A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of StrataGraft Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns
Phase: PHASE1
Conditions: Full Thickness Thermal Burn
Sponsor: Stratatech, a Mallinckrodt Company

O ffici al Titl e :  A P h as e 1/ 2 a, C o ntr oll e d, R a n d o miz e d, M ultic e nt er St u d y Ev al u ati n g t h e Effic ac y, S af et y, a n d   
 T ol er a bilit y of Str at a Gr aft Ov erl a y of M es h e d A ut o gr aft ( S O M A) i n Tr e at m e nt of F ull- T hic k n ess 
         T h er m al B ur ns
N C T N u m b er :   N C T 0 4 7 6 5 2 0 2
D oc u m e nt D at e:    Pr ot oc ol A m e n d m e nt 5 :  2 8 S e pt e m b er 2 0 2 3

C o nfi de ntial a n d Pr o p riet ar y 
   
 
S T R A T A G R A F T ®  C O N S T R U C T  
Pr ot oc ol Title: A P h ase 1/ 2 a, C o ntr olle d, R a n d o mi ze d, M ultice nter St u d y E v al u ati n g t he 
Effic ac y, S afet y, a n d T oler a bilit y of Str at a Gr aft O verl a y of Mes he d A ut o gr aft ( S O M A) i n 
Tre at me nt of F ull -T hic k ness T her m al B ur ns  
Pr ot oc ol N u m ber: M N K 0 1 0 6 2 1 1 7  
A me n d me nt N u m ber: 5  
C o m p o u n d N u m ber: N/ A  
S h ort Title: Str at a S O M A  
D osa ge F or m ulati o n: Strata Graft is a li vi n g, bi oe n gi neere d cell ular tiss ue c o nstr uct t hat is gr o w n 
i n a recta n g ul ar 1 0 0 s q uare ce nti meter f or mat. 
S p o ns or N a me a n d Le g al Re gistere d A d dress:  
Str at atec h C or p or ati o n, a M alli nc kr o dt C o m p a n y 
5 1 0 C h ar m a n y Dri ve , S uite 1 5 0  
M a dis o n, WI  5 3 7 1 9   
U nite d St at es of A meric a  
Re g ulat or y A ge nc y I de ntif yi n g N u m ber: 0 1 0, 1 1 3  
A p pr o val Dat e:  2 8  Se p te m ber 2 0 2 3  

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt  5   
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
2  
C o nfi de ntial a n d Pr o prietar y  
S P O N S O R SI G N A T U R E P A G E  
M y si g nat ure, i n c o nj u ncti o n wit h t he si g nat ure of t he i n vesti gat or, c o nfir ms t he a gree me nt of 
b ot h parties t hat t he cli nical st u d y will be c o n d uct e d i n acc or da nce wit h t he pr ot oc ol a n d 
a p plica ble la ws a n d ot her re g ulati o ns i ncl u di n g, b ut n ot li mite d t o, t he I nter nati o nal C o u ncil f or 
Har m o nisati o n (I C H) G ui deli ne f or G o o d Cli nical Practice ( G C P), t he U S C o de of Fe deral 
Re g ulati o ns ( C F R) ( w h ere a p plica ble), all a p plica ble nati o nal a n d l ocal re g ulati o ns, pr otecti o ns 
f or pri vac y, a n d ge n erall y acce pte d et hical pri nci ples f or h u ma n researc h s uc h as t he Declarati o n 
of Helsi n ki.  
N ot hi n g i n t his d oc u me nt is i nte n de d t o li mit t he a ut h orit y of a p h ys icia n t o pr o vi de e mer ge nc y 
me dical care.  
Refer t o e -si g n at ure p a ge 
S p o ns or Si g nat ure  
 
 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt  5   
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
3  
C o nfi de ntial a n d Pr o prietar y  
A C K N O W L E D G E M E N T O F R E C EI P T A N D U N D E R S T A N DI N G O F  
S P O N S O R S T U D Y M A T E RI A L S  
M y si g nat ure c o nfir ms t h at t he cli nical st u d y will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol 
a n d a p plica ble la ws a n d ot her re g ulati o ns i ncl u di n g, b ut n ot li mite d t o, t he I nter nati o nal C o u ncil 
f or Har m o nisati o n (I C H) G ui deli ne f or G o o d Cli nical Practice ( G C P), t he U S C o de of Fe deral 
Re g ulati o ns ( C F R),  pr otecti o ns f or pri vac y, a n d ge nerall y acce pte d et hical pri nci ples s uc h as t he 
Declarati o n of Helsi n ki.  
N ot hi n g i n t his d oc u me nt is i nte n de d t o li mit t he a ut h orit y of a p h ysici a n t o pr o vi de e mer ge nc y 
me dical care.  
I c o nfir m t h at I h ave receive d, re a d, a n d u n derst o o d t he f oll o wi n g d oc u me nt(s) f or: 
P R O D U C T: 
Strata Graft ®   
S T U D Y:  
Strata S O M A  - Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Pr ot oc ol A me n d me nt 5 , date d 2 8  Se p te m ber 2 0 2 3  
P RI N CI P A L/ C O O R DI N A TI N G I N V E S TI G A T O R( S)  
Na me:  
Title:  
SI G N A T U R E _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ D A T E: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt  5   
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
4  
C o nfi de ntial a n d Pr o prietar y  
S U M M A R Y O F C H A N G E S F O R A M E N D M E N T S  
A me n d me nt 5  i ncl u des c ha n ges rel ate d t o t he F D A’s re visi o n of t he xe n otra ns pla ntati o n 
re q uire me nts f or Strata Graft a n d mi n or  a d mi nist rati ve clarificati o ns . A  c o m plete s u m mar y of t he 
c ha n ges  reflecte d i n t his pr ot oc ol is pr o vi de d i n A p pe n di x  7 . 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt  5   
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
5  
C o nfi de ntial a n d Pr o prietar y  
T A B L E O F C O N T E N T S  
S P O N S O R SI G N A T U R E P A G E  ....................................................................................................2  
A C K N O W L E D G E M E N T O F R E C EI P T A N D U N D E R S T A N DI N G O F S P O N S O R 
S T U D Y M A T E RI A L S  .................................................................................................3  
S U M M A R Y O F C H A N G E S F O R A M E N D M E N T S  .....................................................................4  
1.  
S Y N O P SI S  ...................................................................................................................8  
2.  
S C H E D U L E O F A C TI VI TI E S  ..................................................................................1 2  
3.  
I N T R O D U C TI O N ......................................................................................................1 4  
3. 1.  
St u d y R ati o nale  ...........................................................................................................1 4  
3. 2.  
Bac k gr o u n d  .................................................................................................................1 5  
3. 3.  
Be nefit/ Ris k Assess me nt  ............................................................................................1 6  
4.  
O BJ E C TI V E S A N D E N D P O I N T S ............................................................................1 8  
5.  
S T U D Y D E SI G N  .......................................................................................................2 1  
5. 1.  
O verall  Desi g n  ............................................................................................................2 1  
5. 2.  
Partici pa nt a n d St u d y C o m pleti o n  ..............................................................................2 1  
5. 3.  
E n d of St u d y Defi niti o n  ..............................................................................................2 1  
5. 4.  
Scie ntific Rati o nale f or St u d y Desi g n  ........................................................................2 1  
5. 5.  
J ustificati o n f or D ose ..................................................................................................2 1  
5. 6.  
St u d y St o p pi n g Criteria  ..............................................................................................2 2  
6.  
S T U D Y P O P U L A TI O N  .............................................................................................2 3  
6. 1.  
I n cl usi o n Criteria ........................................................................................................2 3  
6. 2.  
E xcl usi o n Criteria  .......................................................................................................2 3  
6. 3.  
Lifest yle R estricti o ns  ..................................................................................................2 4  
6. 4.  
Scree n Fail ures  ............................................................................................................2 4  
7.  
T R E A T M E N T S  ..........................................................................................................2 5  
7. 1.  
Treat me nt s A d mi nistere d ............................................................................................2 6  
7. 2.  
D ose M o dificati o n  ......................................................................................................2 6  
7. 3.  
Met h o d of Treat me nt Assi g n me nt  ..............................................................................2 6  
7. 4.  
Bli n di n g  ......................................................................................................................2 7  
7. 5.  
Pre parati o n/ Ha n dli n g/ St ora ge/ Acc o u nta bilit y  ............................................................2 7  
7. 6.  
Treat me nt C o m plia nce  ................................................................................................2 7  
7. 7.  
C o nc o mita nt T hera p y  .................................................................................................2 7  

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt  5   
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
6  
C o nfi de ntial a n d Pr o prietar y  
7. 7. 1.  
C o nc o mita nt Me dicati o ns  ...........................................................................................2 7  
7. 7. 2.  
C o nc o mita nt T hera pies  ...............................................................................................2 8  
7. 7. 3.  
Pr o hi bite d Me dicati o ns a n d T hera pies  .......................................................................2 8  
8.  
DI S C O N TI N U A TI O N/ WI T H D R A W A L C RI T E RI A  ...............................................2 9  
9.  
S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S  ......................................................3 0  
9. 1.  
Efficac y Assess me nts  .................................................................................................3 0  
9. 1. 1.  
W o u n d Cl os ure  ...........................................................................................................3 0  
9. 1. 2.  
St u d y Site P h ot o gra p h y  ..............................................................................................3 0  
9. 1. 3.  
Bli n de d Assess me nt of Treate d W o u n d Sites  .............................................................3 0  
9. 2.  
Safet y Assess me nts  .....................................................................................................3 1  
9. 2. 1.  
A d verse E ve nts ( A Es)  .................................................................................................3 1  
9. 2. 2.  
P h ysical E x a mi nati o n a n d Me dical Hist or y Re vie w  ..................................................3 1  
9. 2. 3.  
Vital Si g ns  ..................................................................................................................3 1  
9. 2. 4.  
Cli nical Safet y La b orat or y Assess me nts  ....................................................................3 1  
9. 2. 5.  
A d verse E ve nts of S peci al I nt erest  .............................................................................3 2  
9. 2. 6.  
Ot her Safet y Ass ess me nts  ...........................................................................................3 2  
9. 2. 6. 1.  
I n ci de nce of L ocal W o u n d E ve nts I ncl u di n g I nfecti o n ..............................................3 2  
9. 2. 6. 2.  
Meas ures of I m m u n o ge nicit y  .....................................................................................3 2  
9. 2. 6. 3.  
Arc hi val Sa m ple C ollecti o n  ........................................................................................3 3  
9. 2. 6. 4.  
Hist ol o gic Assess me nt of Heale d Tiss ue C haract eristics  ...........................................3 3  
9. 3.  
P har mac o ki netics  ........................................................................................................3 3  
9. 4.  
P har mac o d y na mics  .....................................................................................................3 3  
9. 5.  
B i o mar kers ..................................................................................................................3 3  
9. 6.  
Healt h Care Res o urce Utilizati o n ( H C R U)  ................................................................3 3  
1 0.  
S T A TI S TI C A L C O N SI D E R A TI O N S  .......................................................................3 5  
1 0. 1.  
Sa m ple Size Deter mi nati o n  ........................................................................................3 5  
1 0. 2.  
P o p ulati o ns f or A nal ys es  ............................................................................................3 5  
1 0. 3.  
Statistical A nal yses  .....................................................................................................3 5  
1 0 . 3. 1. 
A d va nce m e nt t o C o h ort 2  ...........................................................................................3 6  
1 0. 3. 2.  
Efficac y A nal yses  .......................................................................................................3 6  
1 0. 3. 3.  
Safet y A nal yses  ..........................................................................................................3 7  
1 0. 3. 4.  
C o nc o mita nt Me dicati o n a n d Pr oce d ures  ...................................................................3 7  

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt  5   
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
7  
C o nfi de ntial a n d Pr o prietar y  
1 0. 3. 5.  
I nteri m A nal yses .........................................................................................................3 7  
1 1.  
R E F E R E N C E S  ...........................................................................................................3 8  
1 2.  
A P P E N DI C E S  ............................................................................................................3 9  
A p pe n di x 1: A b bre viati o ns a n d Tra de m ar ks  .................................................................................3 9  
A p pe n di x  2: Cli nical La b orat or y Tests  ..........................................................................................4 1  
A p pe n di x 3: St u d y G o ver na nce C o nsi derati o ns  ............................................................................4 2  
Re g ulat or y a n d Et hical C o nsi derati o ns  ..........................................................................................4 2  
Fi na ncial Discl os ur e .......................................................................................................................4 2  
I nf or me d C o nse nt Pr ocess .............................................................................................................4 2  
Data Pr otecti o n ...............................................................................................................................4 3  
C o m mittees Str uct ure .....................................................................................................................4 3  
P u blicati o n P olic y  ..........................................................................................................................4 3  
Data Q ualit y Ass ura nce  .................................................................................................................4 4  
S o urce D oc u m e nts  .........................................................................................................................4 4  
St u d y a n d Site Cl os ure  ...................................................................................................................4 5  
A p pe n di x 4: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, E val uati n g, 
F oll o w -u p, a n d Re p orti n g  ...........................................................................................4 6  
A p pe n di x  5: C o ntrace pti ve G ui da nce a n d C ollecti o n of Pre g na nc y I nf or m ati o n  .........................5 2  
W o ma n of C hil d beari n g P ote ntial ( W O C B P) ................................................................................5 2  
N o n -W O C B P Stat us  ......................................................................................................................5 2  
Pre g n a nc y Testi n g  ..........................................................................................................................5 2  
C ollecti o n of Pre g n a nc y I nf or mati o n .............................................................................................5 3  
Fe male Partici pa nts w h o bec o me pre g na nt ....................................................................................5 3  
A p pe n di x 6: C o u ntr y -s p ecific Re q uire me nts.................................................................................5 4  
A p pe n di x  7: Pr ot oc ol A me n d me nt Hist or y  ...................................................................................5 5  
 
 
LI S T O F T A B L E S  
Ta ble  1:  
Sc he d ule of Acti vities  .................................................................................................1 2  
Ta ble  2:  
S u m mar y of C ha n ges  ..................................................................................................5 5  
 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt  5   
 
8  
C o nfi de ntial a n d Pr o prietar y  
1.    
S Y N O P SI S  
Pr ot oc ol Title:  A P h ase 1/ 2 a, C o ntr olle d, R a n d o mi ze d, M ultice nter St u d y E v al u ati n g t he 
Effic ac y, S afet y, T oler a bilit y of Str at a Gr aft O verl a y of Mes he d A ut o gr aft ( S O M A) i n 
Tre at me nt of F ull -T hic k ness T her m al B ur ns  
S h ort Title: Str at a S O M A  
R ati o n ale:  
T he c urre nt sta n dar d of care f or cl os ure of f ull -t hi c k ness ( F T) b ur ns is a ut o grafti n g, ie, t he 
s ur gical har v est of healt h y s ki n fr o m a n u ni nj ure d site a n d tra ns pla ntati o n of t he har veste d d o n or 
tiss ue t o t he b ur n w o u n d f oll o wi n g s ur gical e xcisi o n of n o n via ble tiss ue. W hile t his met h o d is 
effecti ve i n ac hie vi n g cl os ure of t he ori gi nal w o u n d, a vaila bilit y of sites f or t he har vest of d o n or 
s ki n ma y be li mite d b y b ur n area a n d de pt h, a n d cl os ure of lar ge areas of i nj ur y ma y necessitate 
se q ue ntial re-h ar vest of a vaila ble d o n or sites. Re d ucti o n i n t he a m o u nt of d o n or tiss ue necess ar y 
t o ac hie ve c o m plete w o u n d cl os ure is of cli nical b e nefit, as t he har vest of a d o n or site creates a n 
a d diti o nal partial -t hic k ness w o u n d w hic h a d ds t o t he patie nt’s o verall w o u n d b ur de n a n d is itself 
pai nf ul, s usce pti ble t o i nfecti o n a n d scarri n g, a n d ca n c o n vert t o a F T w o u n d. As a res ult, t here is 
a n ur ge nt nee d f or alter nati ves t hat re d uce  t he area of d o n or site nee de d t o ac hie ve cl os ure of 
b ur n w o u n ds. T he des cri be d i n vesti gati o nal treat me nt is a ntici pate d t o per mit t he use of m ore 
wi del y -m es he d a ut o graft t ha n t he c o m parat or a ut o graft treat me nt , t here b y re d uci n g t he t otal area 
of d o n or s ki n nee d e d t o ac hie ve w o u n d cl os ure.  
O bjecti ves a n d E n d p oi nts  
T he o verall o bjecti ve of t his st u d y is t o e val uate t h e effi cac y, s afet y, a n d t olera bilit y of 
Strata Graft w he n use d as a n o verla y of mes he d a ut o graft t o facilitate w o u n d cl os ure a n d re d uce 
d o n or si te har vest i n t he treat me nt of F T t her mal b ur ns.  
I n t his pr ot oc ol, t he 2 c o m parati ve st u d y treat me nt sites are referre d t o as f oll o ws: 
1.  T he st u d y treat me nt t hat is S trata Graft O verla y of M es he d A ut o graft ( S O M A), w here 
mes he d a ut o graft is a p plie d t o t he b ur n area a n d c o vere d wit h Strata Graft, hereafter is 
referre d t o as “ S O M A T x.” 
2.  T he c o ntr ol treat me nt t hat is mes he d a ut o graft al o ne as a p plie d t o a b ur n area; hereafter is 
calle d “ A G T x.”  
W he n c ollecti vel y referri n g t o b ot h st u d y treat me nts ( ie, t he S O M A T x a n d t he c o ntr ol A G  T x), 
t he y are h ereafter referre d t o as “ St u d y T x.” 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt  5   
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
1 1  
C o nfi de ntial a n d Pr o prietar y  
T he tar get e d e nr oll me nt f or t his st u d y is 4 0 s u bjects wit h F T t her mal  i nj ur y. O n eac h s u bj ect, 
2  w o u n ds, c o m para bl e i n area, w o u n d be d c o m p ositi o n (fat, fascia, or m uscle), a n d ki nesi ol o gic 
stress ors will be i de ntifie d, desi g n ate d as Sites A a n d B, a n d ra n d o mize d t o recei v e eit her A G T x 
(c o ntr ol) or S O M A T x, s uc h t hat eac h s u bject recei ves b ot h treat me nts. F oll o wi n g e xcisi o n, t he 
c o ntr ol a ut o graft treat me nt site will recei ve mes he d s plit -t hic k ness s ki n graft, w hile t he S O M A 
treat me nt site will recei ve a ut o graft t hat is mes he d at 1 or 2 mes h rati o(s) greater t ha n t he c o ntr ol 
treat me nt site a n d o verlai d wit h Strata Graft mes h e d u p t o  1: 1.  
C o h ort 1  will c o nsist of 2 0 s u bjects ra n d o mize d t o o ne of 2 gr o u ps: Gr o u p 1 ( n = 1 0) will recei ve 
A G T x c o nsisti n g of a ut o graft al o ne ( mes h rati o “ m”, per cli nical j u d g me nt) c o m pare d t o S O M A 
T x i n w hic h m + 1: 1 mes he d a ut o graft is o verlai d wit h Strata Graft, w hile Gr o u p 2 ( n = 1 0) will 
recei v e A G T x wit h a ut o graft ( mes h rati o “ m” per cli nical j u d g me nt) c o m p are d t o S O M A T x i n 
w hic h m + 2: 1 mes he d a ut o graft is o verlai d wit h Strata Graft, a p plie d t o w o u n ds of 1 0 0 t o 4 0 0 c m
2 
i n area. S u bjects will be f oll o we d a n d assess me nts perf or me d per t he Sc he d ule of Acti vities 
(Ta ble  1 ). Eac h s u bject will be deter mi ne d t o be a s uccess or fail ure base d u p o n t he criteria 
bel o w, a n d o ne of t he 2 treat me nts, m + 1 or m + 2, will be deter mi ne d t o meet t he a pri ori  
esta blis he d criteria wit hi n t he al g orit h m t o m o ve f or war d:  
•  Perce nt  cl ose d (re -e pit helializati o n) at Da y 2 8, wit h s uccess declare d if t he differe nce 
bet wee n p aire d w o u n ds <  1 0 %  
•  T otal sc ore of O bser ver assess me nt of t he P O S A S at Da y 2 8, wit h s uccess d eclare d if t he 
differe n ce b et wee n p aire d w o u n ds <  2 0 %  
C o h ort 2  will c o nsist of 2 0 s u bjects, all of w h o m will recei ve t he S O M A T x ( wit h a ut o graft 
mes he d at m + 1 or m + 2) i de ntifie d f oll o wi n g assess me nt of C o h ort 1 a n d t he A G T x c o ntr ol, 
a p plie d t o w o u n ds of 4 0 0 t o 1, 9 0 0 c m 2 i n area. S u bjects will be f oll o we d a n d assess me nts 
perf or me d p er t he Sc h e d ule of Acti vities .  
N u m ber of P artici p a nt s: 
A ma xi m u m of 4 0 partici pa nts will recei ve st u d y t reat me nt. 
Tre at me nt Gr o u ps a n d D ur ati o n:  
T his st u d y is o pe n -la bel. S u bjects will ser ve as t heir o w n c o ntr ol. S u bjects will be ra n d o mize d t o 
recei v e a ut o graft, mes he d at a rati o per cli nicia n j u d g me nt at 1 treat me nt site ( m), a n d 
Strata Graft o verla y of a ut o graft at eit her m + 1 or m + 2, relati ve t o t he c o ntr ol mes h rati o.  
It is a ntici pate d t hat eac h s u bject will partici pate i n t his st u d y f or u p t o 1 4 m o nt hs: u p t o 2 wee ks 
of scree ni n g f oll o we d b y u p t o 1 2 m o nt hs ( ± 4 wee ks) of p ost -treat me nt o bs er vati o n.  
E S TI M A T E D D U R A TI O N O F S T U D Y  
E nr oll me nt ~ 3 6  m o nt hs  
D urati o n of s u bject partici pati o n u p t o 6 0 wee ks  
T otal st u d y d urati o n ~ 9 6  m o nt hs  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
1 4  
C o nfi de ntial a n d Pr o prietar y  
3.    
I N T R O D U C TI O N 
I n t he U nite d States i n 2 0 1 3, 5 3, 2 2 0 patie nts re q uire d h os pitalizati o n f or se vere s ki n l oss d ue t o 
b ur n -relat e d i nci de nces a n d, of t h ose i n di vi d uals, 2 9. 4 % ( 1 5, 6 2 5) re q uire d t he s ur gi cal 
i nter ve nti o n of s ki n grafti n g (Mc Der m ott, 2 0 1 6 ). De pe n di n g u p o n t he e xte nt of t he i nj ur y, 
h os pitalizati o n ca n ofte n be pr otracte d. F or s ur vi v ors, t he a vera ge le n gt h of sta y was sli g htl y 
greater t ha n 1 da y p er perce nt  t otal b o d y s urface area ( T B S A) b ur ned bas e d o n t he 2 0 1 8 Nati o nal 
B ur n Re p osit or y a n n u al re p ort of data c ollecte d fr o m 1 0 1 healt h care facilities bet wee n J a n uar y 
2 0 0 8 a n d J u ne 2 0 1 7 ( A merica n B ur n, 2 0 1 7 ). T he mea n le n gt h of h os pital stay is cl ose t o d o u ble 
( 8. 1 vs 4. 5 da ys) t hat of a n y ot her dia g n osis re q uiri n g h os pital sta y. A hi g her perce nta ge of 
pe o ple wit h b ur n -relate d h os pital i n patie nt sta ys die fr o m t heir b ur n-rel ate d i nj uries ( 2. 2 % of 
5 3, 2 2 0 t otal b ur ne d i n patie nts) c o m pare d t o a ll ot her dia g n osis re q uiri n g h os pital i n patie nt sta ys 
( 1. 9 % of 3 5, 5 4 4, 5 7 2 t otal i n patie nts) (Mc Der m ott, 2 0 1 6 ).  
After sta bilizati o n of t he critical care iss ues i n t h ose w h o s ustai n a b ur n -i nj ur y, atte nti o n is 
directe d t o war d b ur n w o u n d ma na ge me nt. T he ulti mate ai m of b ur n w o u n d ma na ge me nt is t o 
pre ve nt w o u n d i nfecti o ns a n d facilitate cl os ure of t he w o u n ds, eit her s p o nta ne o usl y or b y 
a ut ol o g o us s ki n grafts. Ke y ele me nts of b ur n w o u n d ma na ge me nt i ncl u d e clea nsi n g, 
de bri de me nt a n d/ or s ur gical e xcisi o n, a n d a p plicati o n of t o pical a nti micr o bial a ge nts a n d 
dressi n gs.  
Re gar dless of t he a ge of t he patie nt, e vi de nce s u g gests t hat earl y e xcisi o n of b ur n esc har is 
effecti ve i n decreasi n g m or bi dit y, i m pr o vi n g t h e m ortalit y rate, a n d re d uci n g le n gt h of sta y  
(Her n d o n, 1 9 8 9 ; M uller, 1 9 9 4 ) as well as h os pital c osts (M u nster, 1 9 9 4 ). E xcise d areas are 
us uall y cl ose d wit h a ut o graft, or if n ot a vaila ble, all o graft, xe n o graft, or ot h er s ki n s u bstit ute is 
use d u ntil a ut o graft is a vaila ble or t he w o u n d s p o nta ne o usl y cl oses. A vaila bilit y of a ut ol o g o us 
d o n or tiss ue, h o we ver, is li mite d b y t h e e xte nt of t he b ur n i nj ur y, a n d i n lar ger i nj uries, d o n or 
sites are ofte n re peate dl y har veste d, i ncreasi n g t he li keli h o o d of scarri n g at t h ose sites. As s uc h, 
met h o ds t o re d uce t he a m o u nt of d o n or tiss ue nee de d t o ac hi e ve w o u n d cl os ure are al wa ys 
s o u g ht. 
3. 1.    
St u d y R ati o n ale  
Strata Graft is u n der de vel o p me nt b y Stratatec h, a Malli nc kr o dt C o m pa n y, as a n alter nati ve t o 
a ut o grafti n g t o pr o m ote t he heali n g of t her mal b ur ns.  
Cli nical data i n a d ults ha ve s u g geste d t hat treat me nt of dee p partial -t hic k ness ( D P T) t her mal 
b ur ns wit h Strata Graft ca n res ult i n w o u n d cl os ure w hile re d uci n g or eli mi nati n g t he nee d f or 
a ut o graft (H ol mes, 2 0 1 9 ). Cli nical data ha ve als o s h o w n t hat t his tiss ue c o nstr uct d oes n ot 
tra ns pla nt b ut is re place d b y t he patie nt’s cells as t he w o u n d heals. Strata Graft is a n all o ge nei c 
h u ma n tiss ue -e n gi neere d pr o d uct a n d n ot a n a ut ol o g o us, patie nt -s p ecific pr o d uct.  
T his st u d y is bei n g c o n d ucte d i n or der t o e val uate  safet y a n d cli nical o utc o mes ass ociate d wit h 
t he use of Strata Graft as a n o verla y t o mes h e d a ut o graft t o pr o m ote w o u n d cl os ure a n d re d uce d 
area of d o n or site har vest i n t he treat me nt of f ull -t hic k ness ( F T) t her mal b ur ns i n a p o p ulati o n of 
s u bjects wit h t her mall y-i n d uce d F T b ur ns. 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
1 5  
C o nfi de ntial a n d Pr o prietar y  
T his st u d y will be c o n d u cte d i n c o m plia nce wit h a p plica ble re g ulati o ns a n d g ui da nce relate d t o 
G o o d Cli nical Practice ( G C P ) a n d t his pr ot oc ol.  
3. 2.    
B ac k gr o u n d  
Strata Graft ( Stratatec h, a Malli nc kr o dt c o m pa n y, Ma dis o n, WI) is a n  all o ge neic, cell ularize d 
scaff ol d c o nstr uct c urre ntl y u n der e val uati o n f or t he treat me nt of patie nts wit h F T a n d D P T 
b ur ns. It is bila yer, wit h  b ot h a n e pi der mis a n d a der mis. T he e pi der mal la yer is c o m p ose d of 
via ble, stratifie d, h u ma n kerati n oc ytes o n a der mal la yer of h u ma n fi br o blasts e m be d de d i n a n 
a ni mal-deri ve d, n o n -b o vi ne s o urce d T y pe I c olla ge n. T he e pi der mal la yer of Strata Graft is 
c o m p ose d of NI K S ®  kerati n oc ytes, a c o nsiste nt s o urce of ne o natal h u ma n e pi der mal pr o ge nit or 
cells (Alle n -H off ma n n, 2 0 0 0 ). I n precli nical st u dies, NI K S kerati n oc ytes e x hi bit c haracteristic 
e pi der mal differe ntiati o n, i ncl u di n g t he de vel o p me nt of a basal cell la yer wit h a d hesi o n pr otei ns 
a n d he mi -des m os o mes t h at atta c h t o t he der mal e q ui vale nt ( Alle n -H off ma n n, 2 0 0 0 ). Strata Graft 
re pr o d uces t he str uct ural a n d bi ol o gical pr o perties of b ot h t he e pi der mal a n d der mal c o m p o ne nts 
of i nterf ollic ular s ki n. I n a d diti o n, it e x hi bits g o o d i ntra o perati ve ha n dli n g c haracteristics a n d ca n 
be mes he d a n d s ec ure d t o t he w o u n d be d b y s ur gi cal sta pli n g, s ut uri n g, or gl ui n g.  
Strata Graft has bee n e val uate d i n t he treat me nt of D P T w o u n ds i n t he c o m plete d st u dies 
S T R A T A 2 0 1 1 a n d S T R A T A 2 0 1 6.  
I n t he S T R A T A 2 0 1 1 p hase 1 b st u d y of 3 0 s u bjects, n o ne of t he w o u n ds treate d wit h Strata Graft 
u n der we nt a ut o grafti n g pri or t o Da y 2 8 a n d 9 3 % of t he w o u n ds e x hi bite d c o m plete w o u n d 
cl os ure at Wee k 1 2 ( H ol mes, 2 0 1 9 ). Res ults fr o m t he S T R A T A 2 0 1 1 cli nical st u d y s u p p orte d 
e vi de nce t h at treat me nt of c o m ple x s ki n defects c o ntai ni n g i ntact der mal ele me nts wit h 
Strata Graft pr o m otes s ki n re -e pit helizati o n at t he b ur n site wit h o ut t he nee d f or s ur gical 
har vesti n g a n d tra ns pl a ntati o n of a n a ut o graft.  
I n t he S T R A T A 2 0 1 6 p hase 3 st u d y of 7 1 s u bjects, a n a nal ysis of t he c o -pri mar y e n d p oi nts of t he 
a vera ge perce nt area of Strata Graft treat me nt a ut o grafte d b y M o nt h 3 a n d t he perce nt d ura bl e 
w o u n d cl os ure wit h o ut a d diti o nal a ut o grafti n g was perf or me d. T he st u d y o utc o mes met b ot h c o -
pri mar y e n d p oi nts wit h a statisticall y si g nifica nt d ecrease i n mea n perce nt area a ut o grafte d sites 
w he n c o m pari n g Strat a Graft treat me nt sites t o t he a ut o grafte d sites (c o ntr ol) ( p  <  0. 0 0 0 1) . B y 
M o nt h 3, 3 s u bjects ( 4. 2 %) re q uire d a ut o grafti n g of t he Strata Graft treat me nt site, t w o of w h o m 
als o re q uire d a d diti o nal a ut o grafti n g of t heir a ut o grafte d st u d y treat me nt site. A d diti o nall y, 
s uccess f or Strata Graft d ura ble w o u n d cl os ure was o bser ve d w he n t he res ulta nt 9 5 % c o nfi de nce 
i nter val (CI ) l o wer b o u n d of 7 4. 4 % of s u bjects f or Strata Graft was greater t ha n t he 
pre deter mi ne d s uccess of t he 9 5 % CI l o wer b o u n d of ≥ 5 0 % of s u bjects, w he n c o m pare d wit h 
a ut o graft. T he res ulti n g p erce nt d ura ble w o u n d c l os ure was si milar i n b ot h treat me nt gr o u ps 
( Strata Graft 8 3 % vs a ut o graft 8 6 %). 
T hese st u dies i n a d ults wit h D P T t her mal b ur ns ha ve de m o nstrate d t hat, i n t he maj orit y of cas es, 
Strata Graft treat me nt ca n s u bsta ntiall y re d uce or eli mi nate t he nee d f or a ut o gr aft t o ac hi e ve 
w o u n d cl os ure.  
A d diti o nall y, Strata Graft has bee n e v al uate d i n t he treat me nt of F T w o u n ds i n 2  pre vi o us l y 
c o m plete d st u dies: S T R A T A 2 0 0 1 a n d S T R A T A 2 0 1 4. 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
1 6  
C o nfi de ntial a n d Pr o prietar y  
T he S T R A T A 2 0 0 1 st u d y i n vesti gate d t he a d mi nistrati o n of Strata Graft i n 1 5 s u bjects wit h F T 
c o m ple x s ki n defects ( Ce nta n ni, 2 0 1 1 ). I n t his st u d y, s ur gicall y de bri de d ac ute w o u n ds were 
di vi de d i nt o half a n d eac h half ra n d o mize d t o recei ve eit her ca da ver s ki n or Strata Graft as 
te m p orar y cl os ur e pri or t o defi niti ve a ut o grafti n g. T he area of treat me nt was escalate d i n eac h of 
3 c o h orts, i ncreasi n g fr o m a p plicati o n of 4 4 t o 2 2 0 c m 2 of Strata Graft. At a sec o n d pla n ne d 
pr oce d ure, a b o ut 2 w ee ks after place me nt, t he Strata Graft a n d ca da ver s ki n w ere re m o ve d a n d, if 
t he w o u n d was j u d ge d rea d y, a ut o graft was a p plie d. At Wee k 2 after Strat a Graft place me nt, 
a ut o graft “t a ke” was c o m para ble bet wee n ca da ver s ki n a n d Strata Graft f or all 3 c o h orts 
c o m bi ne d ( 9 7. 7 % vs 9 6. 7 % f or Strata Graft a n d ca da ver s ki n, res pecti vel y) (Sc h urr, 2 0 0 9 ). 
F urt her, Strata Graft de m o nstrate d a safet y pr ofile c o m para ble t o ca da ver all o graft.  
T he S T R A T A 2 0 1 4 st u d y was desi g ne d t o assess t he safet y a n d efficac y of si n gle or re peate d 
a p plicati o ns of Strata Graft i n re placi n g a ut o graft f or t he cl os ure of F T s ki n defects. I n t his st u d y, 
u p t o 2 0 s u bjects were t o be e nr olle d i nt o 2 c o h orts wit h 1 0 %  t o 4 9 % (i ncl usi ve) T B S A s ki n l oss 
a n d c o ntai ni n g a n F T c o m p o ne nt. T h o u g h n o safet y c o ncer ns were n ote d i n data safet y 
m o nit ori n g b oar d re vie w of m ulti ple a p plicati o ns of Strata Graft treat me nt per s u bject, t he st u d y 
was cl ose d after e nr oll me nt of 3 s u bjects. All 3 s u bjects re q uire d a ut o grafti n g of s o me p orti o n of 
t he Strata Graft treat me nt site ( w o u n d areas 1 6 5 c m 2 t o 1 8 0 c m 2). Beca use of t he s mall sa m ple 
size, t here was i ns uffici e nt e vi de nce t o dra w c o ncl usi o ns f or st u d y efficac y assess me nts.  
F or Strata Graft t reat me nt of F T s ki n defects, t he S T R A T A 2 0 0 1 res ults de m o nstrate d o utc o mes 
of Strata Graft a p plicati o n t o a n e x cise d F T w o u n d be d t o be si milar t o t h ose ac hie ve d wit h 
ca da v eric all o graft, wit h s u bse q ue nt a ut o graft ta ke t o be greater t ha n 9 5 %. T his st u d y , 
Str ata S O M A, will e val uate t he effi cac y, s afet y, a n d t olera bilit y of Strata Graft t o pr o m ote d ura ble 
cl os ure of b ur n w o u n ds f oll o wi n g a p plicati o n o n t o p of mes he d a n d e x pa n de d a ut o graft, w hile 
re d uci n g t he area of d o n or site har veste d i n t he treat me nt of F T t her mal b ur ns.  
3. 3.    
Be nefit/ Ris k Assess me nt  
Res ults t o date i n dicate t hat Strata Graft is well t olerate d a n d n o cli nicall y o bser va ble all o ge neic 
i m m u ne res p o nses ha ve bee n re p orte d. T he m ost c o m m o n n ote d a d verse reacti o n ass ociate d wit h 
Strata Graft treat me nt is pr urit us.  
T he oretical ris ks s pecific t o Strata Graft treat me nt i ncl u de de vel o p me nt of a n i m m u ne res p o nse t o 
t he all o ge neic cells of Strata Graft a n d t he nee d f or s u bse q ue nt a ut o grafti n g of t he Strata Graft 
treat me nt site. Beca us e Strata Graft c o ntai ns h u ma n cel ls, t here is t he p ossi bilit y of tra ns missi o n 
of a n i nfecti o us a ge nt. A d diti o nall y, Strat a Graft c o ntai ns gl yceri n, t heref ore i n patie nts w h o ha ve 
a gl yceri n se nsiti vit y, t here is a ris k of a n aller gic reacti o n.  
W hile n o cli nicall y rele va nt i m m u ne res p o nse t o Strata Graft has bee n s ee n i n S T R A T A 2 0 0 1, 
S T R A T A 2 0 1 1, S T R A T A 2 0 1 4, or S T R A T A 2 0 1 6, or  t here is a t he oretical p ossi bilit y t hat 
s u bjects w h o m o u nt a n i m m u ne res p o nse t o t he all o ge neic cells of Strata Graft a n d w h o t he n 
bec o me ca n di dates f or recei vi n g s oli d or g a n tra ns pla nts c o ul d e x perie nce a narr o wi n g of t he 
s uita ble d o n or p o ol. 
Data fr o m S T R A T A 2 0 0 1 s h o we d t hat a ut o graft ta ke after treat me nt of t h e w o u n d be d wit h 
Strata Graft was si milar t o ca da v er all o graft, 9 7 % a n d 9 6 %, res p ecti vel y. A d diti o nall y, t h e 2 
S T R A T A 2 0 1 1, t he 3 S T R A T A 2 0 1 4, a n d t he 3 S T R A T A 2 0 1 6  s u bjects w h o recei v e d a ut o graft at 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
1 7  
C o nfi de ntial a n d Pr o prietar y  
sites pre vi o usl y treate d wit h Strata Graft s h o we d c o m plete w o u n d cl os ure bef ore or at M o nt h 3, 
de m o nstrati n g t hat treat me nt wit h Strata Graft d oes n ot i m pe de ac hie ve me nt of w o u n d cl os ure i n 
t he e ve nt a ut o graft is use d t o ac hie ve defi niti ve cl os ure.  
Strata Graft is a xe n otra ns pla ntati o n pr o d uct beca use i n t he past, o ne of t he cell t y pes use d t o 
ma ke Strata Graft was gr o w n wit h m o use cells. T he cell ba n ks ha ve bee n teste d a n d f o u n d t o be 
free of detecta ble i nfecti o us a ge nts a n d m o use cells are n o l o n ger use d i n t he ma n ufact ure of 
Strata Graft.  T here h a ve b ee n n o i de ntifie d healt h c o ncer ns ass o ciate d wit h t hese m o use cells.   
Reci pie nts of x e n otra ns pla ntati o n pr o d ucts are ge nerall y n ot  eli gi ble, per fe deral re g ulati o ns, t o 
d o nate w h ole bl o o d, bl o o d c o m p o ne nts, s o urce plas ma or s o urce l e u k oc ytes. H o we ver, 
i n di vi d ual bl o o d ba n ks ma y re q uest a n e xce pti o n fr o m F D A. Strata Graft reci pie nts wis hi n g t o 
d o nate bl o o d or bl o o d pr o d ucts s h o ul d c hec k wit h t heir d o nati o n ce nter. Strata Graft reci pie nts 
w h o ot her wise meet t he d o n or re q uire m e nts are eli gi ble t o d o nate h u ma n cells, tiss ues, breast 
mil k, o va, s per m, or b o d y parts f or tra ns pla ntati o n.  
T he be nefit of treati n g b ur ns wit h Strata Graft is t hat t he via ble cells of Strat a Graft pr o d uce a n d 
secret e a variet y of pe pti des, gr o wt h fact ors, a n d c yt o ki nes t hat are c ollecti vel y a ntici pate d t o 
facilitate w o u n d re pair a n d tiss ue re ge nerati o n. Cli nical data s u g gest t hat treat me nt of D P T 
t her mal b ur ns wit h Strata Graft ca n res ult i n w o u n d cl os ure w hile re d uci n g or eli mi nati n g t he 
nee d f or a ut o graft a n d als o s u g gest t hat t he c o nstr uct d oes n ot tra ns pla nt, b ut is re place d b y t he 
s u bject’s cells as t he w o u n d heals (H ol mes, 2 0 1 9 ). T he a ntici pate d be nefit of Strata Graft 
treat me nt as a n o v erla y of mes he d a ut o graft is re d ucti o n i n a ut o graft d o n or site har vest; t his 
treat me nt is a ntici pate d t o cl ose t he o pe n w o u n d areas (i nterstices) left after treat me nt wit h 
mes h e d a n d e x pa n de d a ut o graft, pr o vi di n g cli nicia ns t he a bilit y t o use m ore wi del y e x pa n de d 
a ut o graft (ie, wit h a hi g h er mes h rati o), t here b y re d uci n g t he area of a ut o graft har vest fr o m d o n or 
sites.  
M ore detaile d i nf or mati o n a b o ut t he k n o w n a n d e x pecte d be nef its, ris ks, a n d reas o na bl y 
e x pecte d a d verse e v e nts ( A E) ca n be f o u n d i n t he I n vesti gat or’s Br oc h ure.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 0  
C o nfi de ntial a n d Pr o prietar y  
•  Cli nicall y si g nifica nt c ha n ges i n pa nel reacti ve 
a nti b o dies (P R A ) a n d a nti-B S A le vels bet wee n 
Baseli ne a n d M o nt h 3  
•  C o nc o mita nt me dicati o n use  
 
O utc o me Me as ures:  
N u m ber of treat me nt sites wit h c o m plete w o u n d cl os ure wit h o ut a d diti o nal a ut o grafti n g at 
M o nt h 2.  
N u m ber of s u bjects wit h d ura ble w o u n d cl os ure of t he st u d y treat me nt sites wit h o ut a d diti o nal 
a ut o grafti n g at M o nt h 1 2.  
 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 1  
C o nfi de ntial a n d Pr o prietar y  
5.    
S T U D Y D E SI G N  
5. 1.    
O ver all Desi g n  
T his is a m ultice nter, o pe n -la bel, ra n d o mize d, wit hi n-patie nt, c o ntr olle d, mes h -rati o-fi n di n g 
st u d y i n s u bjects wit h 2 % t o 4 9 % (i ncl usi ve) T B S A t her mal b ur n. T he o bjecti ve of t his st u d y is 
t o e val uate t he efficac y, safet y, a n d t olera bilit y of Strata Graft as a n o verla y f or mes he d a ut o graft 
t o pr o m ote c o m plete w o u n d cl os ure  (F o o d a n d Dr u g A d mi nistrati o n [ F D A ], 2 0 0 6) a n d re d uce d 
area of d o n or site har vest e d i n t he treat me nt of F T t her mal b ur ns . 
T he tar get e d e nr oll me nt f or t his st u d y is u p t o 4 0 s u bjects wit h F T t her mal i nj ur y, eac h s u bject 
recei vi n g b ot h S O M A T x a n d A G T x a n d ser vi n g as his or her o w n c o ntr ol. S u bjects will be 
e nr olle d i nt o o ne of 2 co h orts , t he first C o h ort t o deter mi ne a mes h rati o es calati o n w he n 
a ut o graft is use d i n c o nj u ncti o n wit h Strata Graft, a n d t he sec o n d C o h ort t o assess t he e n d p oi nt 
varia bilit y. Bi o psies of t h e heale d Strat a Graft -treat e d w o u n d a n d a dj ace nt  u ni nj ure d s ki n will be 
o btai ne d fr o m s u bjects i n C o h ort 1  at M o nt h 3 t o assess tiss ue arc hitect ure.  
5. 2.    
P artici p a nt a n d St u d y C o m pleti o n  
A p pr o xi matel y 4 0 p artici pa nts will be e nr olle d a n d ra n d o mize d i n t his st u d y. Scree ni n g be gi ns 
wit h e xec uti o n of c o nse nt a n d e nr oll me nt occ urs at t he ti me of place me nt of Strata Graf t. 
5. 3.    
E n d of St u d y Defi niti o n  
S u bjects e nr olle d i n t his st u d y will c o m plete partici pati o n after c o m pleti o n of t he M o nt h 1 2 
assess me nts, wit h dra wal of c o nse nt, or I n vesti gat or wit h dra wal.  
5. 4.    
Scie ntific R ati o n ale f or St u d y Desi g n  
T he c urre nt sta n dar d of care f or c l os ure of F T b ur ns is a ut o grafti n g, i e, t he s ur gical har vest of 
healt h y s ki n fr o m a n u ni nj ure d site a n d s u bse q ue nt tra ns pla ntati o n of t he d o n or tiss ue t o t he 
w o u n d f oll o wi n g s ur gi cal e xcisi o n of n o n via ble tiss ue fr o m t he b ur n. W hile t his met h o d is 
effecti ve i n ac hie vi n g cl os ure of t he ori gi nal w o u n d, o pti mal sites f or t he har vest of d o n or s ki n 
are ofte n li mite d, a n d cl os ure of lar ge areas of i nj ur y ma y necessitate se q ue ntial re -har vest of 
a vaila ble d o n or sites. A d diti o nall y, t h e d o n or site is pai nf ul, s usce pti ble t o i nfecti o n a n d scarri n g, 
a n d ca n c o n vert t o a F T w o u n d. As a res ult, t here is a n ur ge nt nee d f or treat me nt alter nati ves t hat 
re d uce d o n or site har vesti n g f or treat me nt of se vere b ur ns. 
5. 5.    
J ustific ati o n f or D ose  
A maj or fact or li miti n g s ur vi val f oll o w i n g e xte nsi ve t her mal i nj ur y is i ns ufficie nt a vaila bilit y of 
healt h y d o n or sites t o pr o vi de e n o u g h s ki n f or t he re q uire d grafti n g pr oce d ures. I n or der t o 
mi ni mize t he a m o u nt of d o n or site har veste d, d o n or s ki n is ofte n mes he d t o all o w e x pa nsi o n of 
t he a ut ograft a n d i ncreas e t he w o u n d area t hat ca n be c o vere d. H o we ver, s uc h e x pa nsi o n carries 
ris ks s uc h as i nfecti o n of t he w o u n d be d wit hi n t he i nterstices or l o n g-ter m s carri n g of t hese o pe n 
areas, res ulti n g i m pair m e nt of t he graft t o s uccessf ull y i nc or p orate a n d re vasc ularize ( ie,“ta ke”) 
i nt o t he w o u n d d ue t o desiccati o n i n t he f or mer or i n a p o or c os metic a n d/ or f u ncti o nal o utc o me 
i n t he case of t he latter. A n y s u c h graft l oss us uall y necessitates a d diti o nal grafti n g a n d i ncreas es 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 2  
C o nfi de ntial a n d Pr o prietar y  
t he ris ks of m or bi dit y a n d mortalit y. Ale xa n der h y p ot hesize d t hat t he a p plicati o n of all o graft 
o ver wi del y mes he d a ut o graft w o ul d ser ve as a pr otecti ve bi ol o gical dressi n g as t he a ut o graft 
re-vas c ularize d a n d t he n re -e pit helialize d t he mes h i nterstices. T he y re p orte d t he s uccessf ul u se 
of ca da v er s ki n as a n o verla y of wi del y mes he d a ut o graft i n pre ve nti n g t hese p ote ntial a d verse 
o utc o mes i n 1 4 s u bjects a n d 2 2 grafti n g pr oce d ures of 1 % t o 1 5 % T B S A. H o we ver, alt h o u g h 
s uccessf ul i n gai ni n g w o u n d cl os ure, it di d n ot pre ve nt scarri n g i n t he i nterstices d ue t o t he lac k 
of a der mis i n t hese areas ( Ale x a n der, 1 9 8 1 ).  
T he use of A pli graf ® , a si milar F T li vi n g-s ki n a nal o g, was re p orte d i n 3 8 patie nts c o m pari n g 
o utc o mes t o a n i ntra patie nt c o ntr ol of s plit t hic k ness s ki n graft al o ne mes he d at t he sa me rati o 
(Wa y mac k, 2 0 0 0 ). U n d er t he A pli graf o verla y, t he me dia n n u m ber of da ys t o > 7 5 % cl os ure of 
t he i nterstices was 8 d a ys c o m pare d t o 1 3 da ys f or t he c o ntr ol sites. Of i nterest, w o u n ds wit h 
A pli graf o verla y of s plit t hic k ness s ki n graft e x hi bite d si g nifica nt i m pr o ve me nt i n plia bilit y 
c o m pare d t o t he a ut o graft al o ne w o u n ds wit h t he f or mer ac hie vi n g n or mal plia bilit y i n a me di a n 
of 3 5 da ys  c o m pare d t o s uc h rest orati o n i n t he a ut o graft al o ne w o u n ds i n a me dia n of m ore t ha n 
8 4 9 da ys. H o we v er, A pli graf has n ot b ee n a p pr o ve d f or t his use.  
5. 6.    
St u d y St o p pi n g Criteri a  
I n t his st u d y, safet y will be m o nit ore d b y t h e Me dical M o nit or a n d Gl o bal Safet y Lea d fr o m t he 
S p o ns or, as well as t he D ata S afet y M o nit ori n g B oar d ( D S M B). T he D S M B will be i n de pe n de nt 
of st u d y c o n d u ct. S u bject e nr oll me nt will be pa use d pe n di n g disc ussi o n wit h D S M B if a n y of t he 
f oll o wi n g occ ur: 
•  U ne x pecte d i nfecti o n at t he Strata Graft tr eate d site t hat is p ossi bl y or pr o ba bl y relate d 
t o Strata Graft a n d is a n S A E  
•  Se vere ac ute h y perse nsiti vit y reacti o n attri b ute d t o Strata Graft  
•  Deat h attri b ute d t o Strata Graft  
I n t he e ve nt t hat a n y of t hese e ve nts o cc ur, t he l o cal i nstit uti o nal re vie w b oar d (I R B) a n d D S M B 
will be n otifie d. T he Me dical M o nit or will re vie w t he safet y data ass ociate d wit h t he A E  wit h t he 
I n v esti gat or a n d ge n erate a s u m mar y narrati ve. T he Me dical M o nit or, Gl o b al Safet y Lea d, a n d 
D S M B will c o n d uct a c o m pre he nsi ve re vie w of t he safet y data pri or t o res u m pti o n of s u bject 
e nr oll me nt. T he fi n di n gs fr o m t he D S M B will be disc usse d wit h t he S p o ns or cli nical tea m a n d 
Cli nical Trial Lea d pri or t o a n y acti o n bei n g ta ke n.   

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 3  
C o nfi de ntial a n d Pr o prietar y  
6.    
S T U D Y P O P U L A TI O N  
S u bjects a ge d 1 8 t o 7 5  (i ncl usi ve) of eit her se x wit h 2 % t o 4 9 % (i ncl usi ve) T B S A t her mal b ur n, 
i ncl u di n g a pr o p orti o n cli nicall y i n dicat e d f or s ur gical e xcisi o n a n d a ut o grafti n g.  
6. 1.    
I ncl usi o n Criteri a 
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:  
S u bject -s pecific criteri a: 
1.  Partici pa nt m ust be 1 8  to 7 5  years of a ge (i ncl usi ve), at t he ti me of si g ni n g t he i nf or me d 
c o nse nt  
2.  Male or fe m ale  
3.  2 %  t o 4 9 % (i ncl usi ve) T B S A t her mal b ur n area, i ncl u di n g a pr o p orti o n of F T i nj ur y 
cli nicall y i n dicat e d f or s ur gical e xcisi o n a n d a ut o grafti n g   
4.  Ca pa ble of gi vi n g si g n e d i nf or me d c o nse nt as des cri be d i n A p pe n di x 3  w hic h i ncl u des 
c o m plia nce wit h t he re q uire me nts a n d restri cti o ns liste d i n t he i nf or me d c o nse nt f or m 
(I C F) a n d i n t his pr ot oc ol 
Tre at me nt site -s pecific criteri a: 
5.  F ull t hic k ness, t her mal b ur ns f or w hic h e xcisi o n a n d a ut o grafti n g are cli nicall y i n dicate d. 
Matc hi n g treat me nt areas of:  
a. 1 0 0 t o 4 0 0 c m 2 eac h are re q uire d f or s u bj ects e nr olle d i n C o h ort 1  
b.  4 0 0 t o 1, 9 0 0 c m 2 eac h f or s u bjects e nr olle d i n C o h ort 2  
6.  St u d y T x sites l ocate d o n t he t ors o or li m bs ( ma y cr oss j oi n ts) 
6. 2.    
E xcl usi o n Criteri a  
Partici pa nts are e x cl u de d fr o m t he st u d y if a n y of t he f oll o wi n g criteria a p pl y:  
S u bject -s pecific criteri a: 
1.  Pris o ners  
2.  B ur ns of c he mical or electrical ( n o n -t h er mal) eti ol o g y 
3.  Pre g n a nt w o me n  
4.  S u bjects recei vi n g s yste mic i m m u n os u p pressi ve t hera p y at t he ti me of i nj ur y  
5.  S u bjects wit h a k n o w n hist or y of mali g na nc y, e xcl u di n g e xtir pate d basal or s q ua m o us 
cell carci n o ma or mela n o ma.  
6.  Pre -a d missi o n i ns uli n -de pe n de nt dia betic s u bjects  
7.  S u bjects wit h c o nc urre nt c o n diti o ns t hat i n t he o pi ni o n of t he i n vesti gat or ma y 
c o m pr o mise s u bject safet y or st u d y o bjecti ves, s uc h as cli nicall y si g nifica nt i n halati o n 
i nj ur y or i na d e q uate fl ui d res uscitati o n 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 4  
C o nfi de ntial a n d Pr o prietar y  
8.  E x pecte d s ur vi val of < 3 m o nt hs  
9.  Treat me nt sites o n t he face, hea d, nec k, ha n ds, feet, b utt oc ks, ge nitalia,  a n d peri ne u m  
1 0.  Treat me nt sites wit h e x p ose d b o ne or te n d o n  
1 1.  Treat me nt sites directl y a djace nt t o u ne xcise d esc har  
1 2.  Cli nical deter mi nati o n of i nfecti o n at t he a ntici pate d treat me nt sites  
1 3.  Pre vi o us a ut o grafti n g of t he treat me nt sites  
1 4.  C o nc urre nt partici pati o n i n  t he treat me nt ar m of a n ot her i nter ve nti o nal a ge nt or wit hi n 
t he 3 0 da ys pri or t o e nr oll me nt t o t his st u d y (a n “i nter ve nti o nal a ge nt ” is a n y dr u g, d e vice 
or bi ol o gic t hat is bei n g a d mi nistere d u n der a n I N D or I D E. Partici p ati o n i n st u dies of 
n utriti o nal s u p ple me nts is n ot e xcl usi o nar y).  
6. 3.    
Lifest yle Restricti o ns  
N o lifest yle restricti o ns are i m p ose d.  
6. 4.    
Scree n F ail ures  
Scree n fail ures are defi ne d as s u bjects w h o c o nse nt t o partici pate i n t he cli nical st u d y b ut are n ot 
s u bse q ue ntl y treate d wit h Strata Graft. 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 5  
C o nfi de ntial a n d Pr o prietar y  
7.    
T R E A T M E N T S  
T his is a P hase 1/ 2a, m ultice nter, o pe n -la bel, ra n d o mize d, wit hi n-patie nt c o ntr olle d st u d y i n 
s u bjects wit h 2 % t o 4 9 % (i ncl usi ve) T B S A t her mal b ur n. Tar gete d e nr oll me nt f or t his st u d y is u p 
t o 4 0 s u bjects wit h F T t her mal i nj ur y. O n eac h s u bject, 2 w o u n ds c o m para ble i n area, w o u n d be d 
c o m p ositi o n (fat, fascia, or m uscle), a n d ki nesi ol o gic stress ors , will be i de ntifie d, desi g nate d as 
Sites A a n d B, a n d ra n d o mize d t o recei ve eit her c o ntr ol A G T x or S O M A T x, s uc h t hat eac h 
s u bject recei ves b ot h treatme nts. F oll o wi n g e xcisi o n, t he c o ntr ol A G T x  site will recei v e mes he d 
s plit-t hic k ness s ki n graft mes he d per cli nicia n j u d g me nt w hile t he S O M A T x  site will recei ve 
a ut o graft t hat is mes he d at 1 or 2 mes h rati o(s) greater t ha n t he c o ntr ol treat me nt site a n d 
o verlai d wit h Strata Graft mes he d u p t o 1: 1.  
C o h ort 1  will c o nsist of u p t o 2 0 s u bjects ra n d o mize d t o o ne of 2 gr o u ps: Gr o u p 1 ( n = 1 0) will 
recei v e a ut o graft ( mes h rati o “ m”, per cli nical j u d g me nt) c o m pare d t o m + 1: 1 mes he d a ut o graft 
o verlai d wit h Strata Graft , w hile Gr o u p 2 ( n = 1 0) will recei ve mes he d a ut o graft ( mes h rati o “ m”, 
per cli nical j u d g me nt) c o m pare d t o m + 2: 1 mes he d a ut o graft o verlai d wit h Strata Graft, a p plie d t o 
w o u n ds of 1 0 0 t o 4 0 0 c m 2 i n area. S u bjects will be f oll o we d, a n d ass ess me nts perf or me d per  t he 
Sc he d ule of Acti vities ( Ta ble  1 ). Eac h s u bject will be deter mi ne d t o be a s u ccess or fail ure base d 
u p o n t he criteria b el o w, a n d o ne of t he 2 treat me nts, m + 1 or m + 2, will be deter mi ne d t o meet t he 
a pri ori  esta blis he d criteri a wit hi n t he al g orit h m t o m o ve f or war d.  
•  % cl ose d (re-e pit helializati o n) at Da y 2 8, wit h s uccess decl are d if t h e differe nce 
bet wee n p aire d w o u n ds <  1 0 %  
•  T otal sc ore of O bser ver assess me nt of t he P O S A S at Da y 2 8, wit h s uccess d eclare d if 
t he differe nce b et wee n p aire d w o u n ds <  2 0 %.  
C o h ort 2  will c o nsist of 2 0 s u bjects, all of w h o m will recei ve t he treat me nt s uccessf ull y meeti n g 
t he criteria i n C o h ort 1. Briefl y, mat c he d paire d w o u n ds will be ra n d o mize d t o recei ve eit her 
a ut o graft ( mes h rati o “ m ”, per cli nical j u d g me nt) or mes he d a ut o graft 1 or 2 rati os greater t ha n 
“ m” wit h Strata Graft o verla y, t o areas of 4 0 0 t o 1, 9 0 0 c m 2. S u bjects will be f oll o we d, a n d 
assess me nts perf or me d p er t he Sc he d ule of Acti vities  (Ta ble  1 ). 
A d diti o nal details ma y b e f o u n d i n t he st u d y’s ma n ual of pr oce d ures, i ncl u di n g g ui da nce o n 
deter mi ni n g t he a p pr o priate mes h rati os a n d t he use of s yst e mic a n d t o pical 
a nti bi otics/a nti micr o bials.   

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 6  
C o nfi de ntial a n d Pr o prietar y  
7. 1.    
T re at me nts A d mi nistere d  
St u d y T x  
Str at a Gr aft C o nstr uct  
D os a ge f or m ul ati o n  
Strata Graft is a via ble a n d meta b olicall y acti ve all o ge neic 
h u ma n NI K S kerati n oc ytes a n d h u ma n der mal fi br o blasts 
cell ularize d la yere d scaff ol d . It is s u p plie d i n a recta n g ular, 
1 0 0  c m 2 f or mat, l o osel y a d here nt t o a p ol ycar b o nate 
me m bra ne of a tiss ue i nsert. Strata Graft is st ore d 
at -7 0° C  t o -9 0° C u ntil t ha we d f or use.  
U nit d ose stre n gt h(s)/ D os a ge 
le vel(s) 
1 a p plicati o n of 1 c m 2 Strata Graft per 1  c m 2 de bri de d  w o u n d. 
T he d osa ge of St rata Graft is t he t otal s urface area of 
Strata Graft a p plie d d uri n g a n y s ur gical pr oce d ure.  
R o ute of A d mi nistr ati o n  
Strata Graft is a p plie d t o picall y t o c o m ple x s ki n defects t hat 
ha ve bee n s ur gicall y e xcise d t o re m o ve n o n via ble tiss ue. It is 
mes he d u p t o 1: 1, place d o nt o t he w o u n d be d, tri m me d t o fit 
t he w o u n d as necessar y, a n d sec ure d i n place. 
D osi n g i nstr ucti o ns  
 
1 a p plicati o n of Strata Graft t o w o u n ds of 1 0 0 t o 4 0 0 c m 2 i n 
C o h ort 1 or 4 0 0 t o 1, 9 0 0 c m 2 i n C o h ort 2, wit h a p plicati o ns 
o verla yi n g mes he d a ut o g raft 
M a n uf act urer  
Stratatec h, a Malli nc kr o dt C o m pa n y  
7. 2.    
D ose M o dific ati o n  
N o d ose m o dificati o n is pla n ne d.  
7. 3.    
Met h o d of Tre at me nt Assi g n me nt  
T his st u d y is desi g n e d as a n o pe n la bel, wit hi n -s u bject c o m parat or st u d y. 
F or ra n d o mizati o n of St u d y T x sites wit hi n eac h s u bject, a n i nteracti ve v oi ce ra n d o mizati o n 
s yste m will be use d i n t his st u d y a n d sites trai ne d o n its use.  
F or eac h s u bject, after e x cisi o n / de bri de me nt is c o m plete d a n d t he St u d y T x sites are c o nfir me d 
t o meet Eli gi bilit y  C riteria, c o m para ble (ie, si milar i n b ot h area a n d de pt h) St u d y T x sites will be 
i de ntifie d as A a n d B b y t he s ur ge o n as o utli ne d bel o w:  
•  Treat me nt Site A will al wa ys be a nteri or, s u peri or, pr o xi mal, lateral or t o t he s u bject’s 
ri g ht  
•  Treat me nt Site B will al wa ys be p osteri or, i nferi or, distal, me dial or t o t he s u bject’s left  
After a n at o mical assi g n me nt of St u d y T x sites t o Site A a n d Site B is c o m plete d per pr ot o c ol 
defi niti o ns, St u d y T x sites will be ra n d o mize d t o recei ve eit her:  
1.  Mes he d a ut ol o g o us s plit -t hic k ness s ki n graft (ie, A G T x)  
2.  Mes he d a ut o graft o verlai d wit h  u p t o  1: 1 mes h of Strata Graft ( ie, S O M A T x):  
a. 1 mes h rati o great er t ha n t he c o ntr ol site  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 7  
C o nfi de ntial a n d Pr o prietar y  
b.  2 mes h rati os great er t ha n t he c o ntr ol site  
7. 4.    
Bli n di n g  
T his st u d y will be o pe n  l a bel f or t he i n vesti gat ors perf or mi n g t he care of e nr olle d s u bjects, 
i ncl u di n g t he a p plicati o n of t he St u d y T xs. All w o u n d  assess me nts, h o we ver, will be perf or me d 
b y a pre vi o usl y desi g nate d bli n de d assess or.  
7. 5.    
Pre p ar ati o n/ H a n dli n g/ St or a ge/ Acc o u nt a bilit y  
Strata Graft will be s hi p p e d t o t he st u d y site o n dr y ice. U p o n arri val, Strat a Graft ma y be 
mai ntai ne d i n t he seale d s hi p pi n g c o ntai ner u ntil t he date a n d ti me i n dicat e d o n t his c o ntai ner. If 
t he Strata Graft will n ot be use d u ntil after t he date a n d ti me i ndicate d o n t he s hi p pi n g c o ntai ner, 
u p o n arri val at t he site , Strata Graft s h o ul d be tra nsferre d fr o m t he s hi p pi n g c o ntai ner t o a s ec ure, 
ultra -c ol d (-7 0 °C t o -9 0 °C) freezer wit h m o nit ore d te m perat ure. O nce Strata Graft has bee n 
recei v e d at t he site, tra nsferre d i nt o a site’s ultra-c ol d freezer, a n y e xc ursi o n fr o m re q uire d 
st ora ge ra n ge m ust be re p orte d t o t he S p o ns or as s o o n as it bec o mes k n o w n a n d pri or t o cli nical 
use. O nl y s u bjects e nr oll e d i n t he st u d y ma y recei ve St u d y T x a n d o nl y a ut h orize d site staff m a y 
s u p pl y or a d mi nister St u d y T x.  
T he i n vesti gat or or t he hea d of t he me dical i nstit uti o n ( w here a p plica ble) is res p o nsi ble f or St u d y 
T x acc o u nta bilit y, rec o nciliati o n, a n d rec or d mai nt e na nce ( ie, recei pt, rec o nciliati o n, a n d fi nal 
dis p ositi o n rec or ds).  
F urt her g ui d a nce a n d i nf or mati o n f or t he St u d y T x pre parati o n, ha n dli n g, a d mi nistrati o n, a n d 
dis p ositi o n of u n use d St u d y T x are pr o vi de d i n a pr oce d ure ma n ual.  
7. 6.    
Tre at me nt C o m pli a nce  
St u d y T x ma y o nl y b e a d mi nistere d b y a trai ne d p h ysicia n. All st u d y staff a n d partici pati n g 
s u bjects a n d/ or care gi vers will be i nstr ucte d o n t he a p pr o priate care of t he b ur n w o u n ds treat e d 
wit h t he st u d y pr o d ucts.   As t his st u d y i n c or p orates t he use of a n i ntra patie nt c o ntr ol, t he t w o 
treat me nt sites are t o be dresse d/ ma na ge d with t he sa me re gi me n wit h e xce pti o ns bei n g t he use 
of a t o pical dr u g f or s us pecte d i nfecti o n or a not her mala d y.  
7. 7.    
C o nc o mit a nt T her a p y  
7. 7. 1.    
C o nc o mit a nt Me dic ati o ns  
A n y me di cati o n or vacci ne t hat t he partici pa nt recei ves fr o m t he ti me of e nr oll me nt ( ie, 
a p plicati o n o f Strata Graft) u ntil c o m pleti o n of st u d y partici pati o n will be rec or de d, i ncl u di n g 
na me of dr u g, i n dicati o n f or a d mi nistrati o n, dates of a d mi nistrati o n, d ose a d mi nistere d, a n d r o ute 
of a d mi nistrati o n.  
I ntra ve n o us fl ui ds, a nest hetic a ge nts, vita mi ns, oral n utriti o n, a n d n utriti o nal s u p ple me nts are n ot 
c o nsi dere d c o nc o mita nt me dicati o ns f or t he p ur p oses of t his st u d y a n d s h o ul d n ot be e ntere d i nt o 
t he C o nc o mita nt Me dicati o ns. 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
2 8  
C o nfi de ntial a n d Pr o prietar y  
7. 7. 2.    
C o nc o mit a nt T her a pies  
All s ur gical pr oce d ures p erf or me d, i n cl u di n g all a ut o grafti n g  pr oce d ures, will be rec or de d, 
i ncl u di n g date a n d t he pri mar y reas o n f or t he pr oce d ure. A d diti o nall y, all tra nsf usi o ns of w h ole 
bl o o d, pac ke d re d bl o o d cells, fres h fr oze n plas ma, or platelets will be rec or de d, i ncl u di n g date 
of tra nsf usi o n, v ol u me of tra n sf usi o n, a n d i n dicati o n f or t he tra nsf usi o n.  
After t he treate d w o u n ds ha ve heale d, a n y use of c o m pressi o n gar me nts, s pli nts, or t o pical 
silic o ne s heet a p plicati o ns a n d a n y ot her s car pre ve nti o n t hera pies will be rec or de d.  
7. 7. 3.    
Pr o hi bite d Me dic ati o ns a n d T her a p ies 
S u bjects e nr olle d i n t his st u d y ma y N O T recei ve t he f oll o wi n g f or t he d urati o n of st u d y 
partici pati o n:  
•
Dressi n gs or w o u n d was hes a p plie d t o t he treat me nt sites c o ntai ni n g sil ver or s ulfa m yl o n
( wit h acti ve i n gre di e nt mafe ni de acet ate) wit h o ut t h or o u g h ri nsi n g wit h sali ne pri or t o
Strata Graft place me nt a n d n o f urt her use f or d urati o n of St u d y T x
•
Re Cell ™ use o n a n y st u d y T x sites
•
V A C t hera p y t o t he St u d y T x sites
•
Las er t hera p y t o t he St u d y T x sites

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
2 9  
C o nfi de ntial a n d Pr o prietar y  
8.    
DI S C O N TI N U A TI O N/ WI T H D R A W A L C RI T E RI A   
S u bjects are free t o wit h dra w c o ns e nt a n d disc o nti n ue partici pati o n i n t he st u d y at a n y ti me. If a 
s u bject deci des t o disc o nti n ue partici pati o n, t he reas o n(s) f or dis c o nti n uati o n will be 
d oc u me nte d.  
S u bjects disc o nti n ue d fr o m t he st u d y d ue t o a n A E will b e f oll o we d u ntil t he A E has res ol ve d or 
is j u d ge d as cli nicall y sta ble b y t he I n vesti gat or.  
T he i n vesti gat or ma y dis c o nti n ue a s u bject’s parti ci pati o n at a n y ti me if s/ he feels it is i n t he 
s u bject’s best i nterest t o be disc o nti n ue d. A d diti o nall y, t he s u bject ma y be c o nsi dere d l ost t o 
f oll o w-u p after 3 d oc u me nte d atte m pts are ma de t o c o ntact t he s u bject.  
All st u d y data fr o m wit h dra w n or disc o nti n ue d s u bjects will be retai ne d a n d use d i n t he fi nal 
st u d y a nal ys es.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 0  
C o nfi de ntial a n d Pr o prietar y  
9.    
S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S  
T he St u d y T x sites will be seriall y e v al uate d t o assess w o u n d heali n g pr o gress.  
9. 1.    
Effic ac y Assess me nts  
9. 1. 1.    
W o u n d Cl os ure  
C o m plete w o u n d cl os ure is defi ne d as c o m plete s ki n re -e pit helializati o n wit h o ut drai na ge 
c o nfir me d at 2 visits at least 2 wee ks a part  b ut n o later t ha n  Wee k 2 0 .  C o m plete w o u n d cl os ure 
will be c o nsi dere d t o ha ve occ urre d at t he earlier of t he t w o o bser vati o ns of c o m plete s ki n re -
e pit helializati o n wit h o ut drai na ge. T he bli n de d ass ess or will e val uate treat me nt site(s) a n d assess 
t he pr o p orti o n of t he treate d w o u n d cl ose d be gi n ni n g at Da y 7 a n d t he n dail y , or as ofte n as 
p ossi ble , d uri n g dressi n g c ha n ges  u ntil w o u n d cl os ure is ac hie ve d.   
D ura ble w o u n d cl os ure is defi ne d as p ersiste nce of cl os ure, mai ntai ne d f or at least 3 m o nt hs after 
t he i nitial o bser vati on of cl os ure ( F D A, 2 0 0 6 ). T he bli n de d assess or will e val uate t he w o u n d 
sites at eac h visit s u bse q ue nt t o w o u n d cl os ure t o assess t he mai nte na nce of t he cl os ure.  
B ot h c o m plete w o u n d cl os ure a n d d ura b le w o u n d cl os ure will be assesse d b y direct cli nicia n 
o bser vati o n d uri n g a st u d y visit .  C o nfir mati o n of cl os ure (ie, t he visit 2 wee ks after t he first 
o bser vati o n of cl os ur e ), ma y b e assesse d b y direct cli nical o bser vati o n or b y s u bject -pr o vi de d 
p h ot o gra p hs , per Sc he d ule of Acti vities  (Ta bl e  1 ). 
9. 1. 2.    
St u d y Site P h ot o gr a p h y  
P h ot o gra p hs will be ta k e n at eac h st u d y visit t o s u p p ort cli nical assess me nt of c o m plete w o u n d 
cl os ure, d ura bl e w o u n d cl os ure, a n d a d verse site e ve nts, as well as t he  P O S A S/ P S A Q 
assess me nts ( ie, a p p eara nce a n d c os mesis) of t he treat me nt sites.  
F oll o wi n g h os pital disc h ar ge, t he s u bject will ha ve t he o pti o n t o s u b mit p h ot o gra p hs of t he St u d y 
T x sites eac h wee k u ntil M o nt h 3, e ver y ot her wee k u ntil M o nt h 6, a n d t he n m o nt hl y u ntil t he 
M o nt h 1 2 visit. I n t h e e v e nt t hat a s u bject is u na bl e t o tra vel t o t he st u d y site f or a visit or if a 
n ota ble e ve nt has occ urre d bet wee n sc he d ule d visits, p h ot o gra p hs s u b mitte d ma y be use d as 
e vi de nce of w o u n d c h aracteristics. See t he p h ot o m a n ual f or s pecific i nstr ucti o ns t o o btai n 
p h ot o gra p hs.  
9. 1. 3.    
Bli n de d Assess me nt of Tre ate d W o u n d Sites  
At eac h cli nical st u d y sit e, a pri mar y a n d bac k -u p assess or will be i de ntifie d. T hese i n di vi d uals 
will be tas ke d wit h assessi n g w o u n d cl os ure a n d o nce cl ose d, t he d ura bilit y of t hat cl os ure, a n d 
will be q ualifie d t o d o s o b y trai ni n g a n d cli nical e x perie nce. Care s h o ul d be ta ke n t o e ns ure 
t hese i n di vi d uals re mai n bli n de d t o t he ra n d o mize d treat me nt. Bli n de d assess me nt of all St u d y 
T x w o u n ds will be gi n o n t he Da y  7 visit, a n d t he n dail y, or as ofte n as p ossi ble  d uri n g dressi n g 
c ha n ges  u ntil t he w o u n d is c o m pletel y cl os e d, a n d t he n perf or me d at eac h visit f or t he d urati o n 
of t hat s u bject’s st u d y p artici pati o n.   

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 1  
C o nfi de ntial a n d Pr o prietar y  
9. 2.    
S afet y Assess me nts  
Pla n ne d ti me p oi nts f or all safet y  assess me nts are pr o vi de d i n t he Sc he d ule of Acti vities. Safet y 
assess me nts will i ncl u de m o nit ori n g of A Es, vital si g ns, la b orat or y val ues, i nci de nce of w o u n d -
i nfecti o n relate d e ve nts, a n d i m m u n ol o gic res p o nses t o Strata Graft. 
9. 2. 1.    
A d verse E ve nts ( A Es)  
All A Es t hat occ ur after t he s u bject has si g ne d t he st u d y I C F will be c ollect e d f or t he d urati o n of 
t heir partici pati o n. It is a ntici pate d t hat eac h s u bj ect will partici pate i n t his st u d y f or u p t o 
1 4  m o nt hs: u p t o 2 wee ks of scree ni n g f oll o we d b y u p t o 1 2 m o nt hs ( ± 4 wee ks) of 
p ost -treat me nt o bser vati o n. See A p pe n di x 4  f or f urt her descri pti o n a n d i nf or mati o n cate g orizi n g 
A Es.  
9. 2. 2.    
P h ysic al E x a mi n ati o n a n d Me dic al Hist or y Re vie w  
A brief p h ysical e xa mi nati o n will be perf or me d a n d will i ncl u de, at a mi ni m u m, assess me nts of 
t he s ki n ( ot her t ha n t he b ur n i nj ur y), l u n gs (i ncl u di n g a n y e vi de nce of i n hal ati o n i nj ur y), 
car di o vas c ular s yste m, a n d a b d o me n. As q ualit y of t he heale d St u d y T x si tes is o ne of t he 
pri mar y e n d p oi nts, p ote ntial St u d y T x sites wit h visi ble pre -e xisti n g scars s h o ul d be e xcl u de d 
fr o m c o nsi derati o n. 
A me dical hist or y, i ncl u di n g all pre vi o us s ur gi cal pr oce d ures a n d pre g na nc y hist or y, w here 
a p pr o priate, will be s olicite d f r o m t he s u bject or a bstracte d fr o m t he me dical rec or d, wit h s pecial 
atte nti o n gi ve n t o a n y c hr o nic ill nesses e xisti n g pri or t o t he b ur n i nj ur y.  
9. 2. 3.    
Vit al Si g ns  
Vital si g ns will i ncl u de te m perat ure, s yst olic a n d diast olic bl o o d press ure, a n d heart rate. 
W he ne ve r p ossi ble, vital si g ns will be o btai ne d usi n g a ut o mat e d de vices rat her t ha n ma n ual 
met h o ds.  
9. 2. 4.    
Cli nic al S afet y L a b or at or y Assess me nts  
La b orat or y assess me nts of C M P a n d C B C, as well as uri ne pre g na nc y tests f or w o me n of 
c hil d beari n g p ote ntial, will be perf or me d at t he l ocal cli nical la b orat or y of t he cli nical site.  P R A 
a n d a nti-b o vi ne ser u m al b u mi n (a nti-B S A ) a nti b o d y ass ess me nts will be perf or me d b y a ce ntral 
la b orat or y. A list of all cli nical la b orat or y tests t o be perf or me d is pr o vi de d i n A p pe n di x  2  a n d 
t he Sc he d ule of Acti vities n otes t he ti mi n g a n d fre q ue nc y. It is prefera ble t hat, if p ossi ble, 
la b orat or y a n al ys es re q uire d b y t his st u d y are o btai ne d i n c o nj u ncti o n wit h ot her cli nical 
necessar y a nal ys es a n d d u plicati ve a nal yses are t o be a v oi de d.  
T he i n vesti gat or will re vi e w t he la b orat or y re p ort, d oc u me nt t his re vie w, a n d rec or d a n y 
cli nicall y rele va nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E s ecti o n of t he case re p ort f or m 
(C R F ). T he la b orat or y re p orts will be mai ntai ne d wit h t he st u d y s o urce d oc u me nts. Cli nicall y 
si g nifica nt a b n or mal la b orat or y fi n di n gs are t h ose w hic h are n ot ass ociate d wit h t he u n derl yi n g 
disease, u nless j u d ge d b y t he i n vesti gat or t o b e m ore  se vere t ha n e x pecte d f or t he partici pa nt's 
c o n diti o n.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 2  
C o nfi de ntial a n d Pr o prietar y  
All la b orat or y tests wit h val ues c o nsi dere d cli nicall y si g nifi ca ntl y a b n or mal d uri n g partici pati o n 
i n t he st u d y will be re p eate d as ofte n as d ee me d cli nicall y a p pr o priate, u ntil t he val ues ret ur n t o 
n o r mal or baseli ne or are n o l o n ger c o nsi dere d cli nicall y si g nifica nt. A b n or mal la b orat or y res ults 
are n ot, of t he msel v es, A Es a n d will n ot be re p orte d as s uc h b ut i de ntificati o n of t he r o ot ca us e of 
t he a b n or malit y s h o ul d b e i n vesti gat e d, as it ma y be a n A E. 
9. 2. 5.    
A d verse E ve nts of S peci al I nterest   
A n A d verse E ve nt of S pecial Interest (A E SI ), w het her seri o us or n o nseri o us, is o ne of scie ntific 
a n d me dical c o ncer n s pecific t o t he s p o ns or ’s pr o d uct or pr o gra m, f or w hic h o n g oi n g m o nit ori n g 
a n d ra pi d c o m m u nicati o n b y t he i n vesti gat or t o t he s p o ns or ca n be a p pr o priate. A E SI will be 
re p orte d usi n g t he S A E/ A E SI Re p ort F or m a n d o bser ve t he sa m e re p orti n g ti meli ne (A p pe n di x 
4 ). F or t his st u d y, A E SI i ncl u de:  
•  U ne x pecte d or u n us ual i nfecti o ns   
•  Der mat ol o gical mali g na nc y  
9. 2. 6.    
Ot her S afet y Assess me nt s 
9. 2. 6. 1.  
I nci de nce of L oc al W o u n d E ve nts I ncl u di n g I nfecti o n 
St u d y T x sites wi ll be e xa mi ne d b y t h e i n vesti gat or at eac h visit f or si g ns of s ki n d yscrasias, s uc h 
as vesicle or b ullae f or m ati o n, irritati o n, ras h, dr y ness as well as si g ns of i nfecti o n. A n y n ote d 
iss ue will be re p orte d as a n A E.  
L ocal St u d y T x site i nfecti o n will be d eter mi ne d b y t he cli nical i n vesti gat or a n d ma y i ncl u de 
c o nfir mat or y micr o bi ol o gical assess me nt. Si milarl y, s yste mic i nfecti o n will be deter mi ne d b y t he 
cli nical i n vesti gat or a n d ma y i ncl u d e d oc u me ntati o n of s uc h si g ns as p ositi ve bl o o d c ult ures, 
fe ver ( defi n e d as > 3 8. 5 oC) a n d/ or ele vat e d w hite bl o o d cell c o u nt. C ult ures of t he treat me nt sites 
ma y b e o btai ne d f or micr o bi ol o gical e val uati o n at t he discreti o n of t he cli ni cal i n vesti gat or or per 
i nstit uti o nal Sta n dar d of Care at a n y ti me d uri n g st u d y treat me nt. T he cli ni cal i n vesti gat or will 
e val uate t he w o u n d c ult ure res ults f or i nfecti o ns a n d t heir treat me nt will be d oc u me nte d i n t he 
electr o nic case re p ort f or m (e C R F) wit h n otati o n of s pecific l ocati o n of t he i nfecti o n.  
At i n vesti gat or discreti o n, treat me nt o f i nfecte d/s us pecte d i nfecte d w o u n d sites ma y i ncl u de t h e 
use of tar get e d w o u n d cl ea nsi n g a ge nts, t o pical a nti micr o bial a ge nts a n d/ or s yste mic a nti bi otics. 
St u d y w o u n d sites ma y n ot be treate d wit h a n y pr o hi bite d t hera pies, as o utli ne d i n Secti o n  7. 7. 3 . 
9. 2. 6. 2.  
Me as ures of I m m u n o ge nicit y  
Bl o o d sa m ples will be c ollecte d pri or t o place me nt of S O M A a n d a gai n at M o nt h 3 t o assess 
c ha n ges i n P R A a n d a nti -B S A le vels. P R A is a meas ure of a nti b o d y f or mati o n t o n o n -self h u ma n 
pr otei ns s uc h as t h ose f o u n d i n Strata Graft. T he cells i n Strata Graft are c ult ure d i n me dia 
c o ntai ni n g B S A a n d a nti -B S A a nti b o dies ma y be f or me d wit h e x p os ure t o Strata Graft. F or 
f urt her det ails, see t he ce ntral la b orat or y ma n ual.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 3  
C o nfi de ntial a n d Pr o prietar y  
9. 2. 6. 3.  
Arc hi v al S a m ple C ollecti o n  
I n acc or da n ce wit h c urre nt x e n otra ns pla ntati o n pr o d uct g ui deli nes, a n arc hi val sa m ple will be 
c ollecte d at Baseli ne pri or t o Strata Graft place m e n t. A s mall a m o u nt of bl o o d ( 3 m L) will be 
c ollecte d bef ore Strat a Graft a p plicati o n. T his sa m ple c o ul d be use d as a baseli ne t o assess healt h 
iss ues t hat ma y be relat e d t o treat me nt. T hese s a m ples will be use d o nl y f or t he p ur p ose of 
res p o n di n g t o a re q u est fr o m F D A. B ot h arc hi v al sa m ples a n d a n y ass o ciate d s u bject i nf or mati o n 
will be st ore d a n d use d o nl y as re q uire d a n d all o we d b y l a w. F or f urt her d et ails, see t he ce ntral 
la b orat or y ma n ual.  
9. 2. 6. 4.  
Hist ol o gic Assess me nt of He ale d Tiss ue C h ar acteristics  
S u bjects  i n C o h ort 1 w h o ha ve c o nse nt e d  will ha ve a b i o ps y o btai ne d fr o m t heir heale d S O M A 
T x site. A 3 -m m p u nc h bi o ps y will be har veste d fr o m t he ce ntral secti o n of t he m ost ri g ht, 
lateral, a n d pr o xi mal area of t he heale d S O M A T x w o u n d . A sec o n d 3-m m p u nc h bi o ps y will be 
ta ke n fr o m a n area of u ni nj ure d s ki n a djace nt t o t he heale d S O M A T x w o u n d.  T he res ulta nt 
w o u n d will be  ma na ge d per i nstit uti o nal sta n dar d.  
T he bi o ps y tiss ue will be e x a mi ne d usi n g sta n dar d hist ol o gic tec h ni q ues a n d assesse d f or 
c haracteristics s uc h as arc hitect ure, prese nce of i m m u ne cells, elasti n a n d c olla ge n distri b uti o n.  
F or f urt her det ail, see t he Ma n ual of Pr oce d ures . 
9. 3.    
P h ar m ac o ki netics  
P har mac o ki netic  para met ers are n ot e val uate d i n t his st u d y.  
9. 4.    
P h ar m ac o d y n a mics  
P har mac o d y na mic p ara m eters are n ot e val u ate d i n t his st u d y.  
9. 5.    
Bi o m ar kers  
N o Bi o mar k ers will be assesse d i n t his st u d y.  
9. 6.    
He alt h C are  Res o urce  Utiliz ati o n  ( H C R U) 
H C R U data t hat are ass o ciate d wit h me dical e nc o u nters will be re p orte d i n t he C R F b y t he 
i n vesti gat or a n d st u d y-sit e pers o n nel f or all partici pa nts t hr o u g h o ut t he st u d y. Pr ot oc ol-ma n date d 
pr oce d ures, tests, a n d e n c o u nters are e xcl u de d.  
T he data c ollecte d ma y b e use d t o c o n d uct e x pl orat or y ec o n o mic a nal ys es a n d will i ncl u de:  
•  L ocati o n of care f or Strat a Graft a p plicati o n ( e g, i n patie nt h os pital, 
o ut patie nt/a m b ulat or y h os pital, cli nic)  
•  Treat me nts use d f or all ot her n o n -st u d y b ur n areas f oll o wi n g e xcisi o n a n d % T B S A 
treate d wit h eac h  
•  N u m ber a n d d urati o n of o perati n g r o o m pr oce d ures re q uire d f or st u d y b ur n treat me nt  
•  Le n gt h of i nitial h os pital sta y a n d a n y rea d missi o ns  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 4  
C o nfi de ntial a n d Pr o prietar y  
•  Prescri pti o n dr u gs gi ve n f or pai n c o ntr ol  
•  A nti bi otics gi ve n f or o ut patie nt use at disc har ge  
•  W het her a re -a d missi o n is pla n ne d  
•  Re -a d missi o n wit hi n 3 0 da ys after disc har ge  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 5  
C o nfi de ntial a n d Pr o prietar y  
1 0.    
S T A TI S TI C A L C O N SI D E R A TI O N S   
1 0. 1.   
S a m ple Size Deter mi n ati o n  
T he sa m ple size f or t he st u d y is base d o n cli nical e x perie nce. N o calc ulati o ns were perf or me d t o 
esti mate sa m ple size. U p t o  4 0 s u bjects will be e nr olle d i n 2 c o h orts  ( detaile d i n Secti o n  7 ).  
1 0. 2.   
P o p ul ati o ns f or A n al yses  
F or p ur p oses of a n al ysis, t he f oll o wi n g a nal yses s ets are defi ne d:  
P o p ul ati o n  
Descri pti o n  
E nr olle d  
All s u bj ects w h o si g n t he I C F  
F ull a n al ysis set ( F S A)  
All s u bj ects w h o are ra n d o mize d a n d treate d wit h at least o ne area of 
S O M A T x a n d o ne area of A G T x . Efficac y a nal yses will be base d o n 
treat me nt a p plie d (as treate d).  
Per -Pr ot oc ol set ( P P S)  
All s u bj ects i n t he F S A e xce pt f or t h ose w h o are e xcl u de d beca use of 
maj or efficac y -relate d pr ot oc ol de viati o n. A  ma jo r pr ot oc o l v io latio n  is 
o ne  t hat m a y affect  t he i nter pretati o n  o f st u dy  r es ults. T h e crit eria o f 
m a jo r pr ot oc o l de via tio n s ma y i n cl u d e b ut is n ot li mit e d t o d e vi ati o n 
fr o m: 
•  
A  pa tie n t w h o  d oe s n o t ha ve pri mar y e n d p oi nt val ue  
•  
A n y  maj or  vi o lati o ns of efficacy -relate d e ntr y cr it eria 
•  
D e vi ati o n of a n i n cl usi o n or e x cl usi o n crit eri o n  
Maj or pr ot oc ol de vi ati o ns w ill be revi ewe d  case b y  case o n a  reg ul ar 
b asis d urin g  t he co n d u ct of t he st ud y  b y  the  M edi cal M o nit or  an d  
cli nical trial man ag em ent t eam a n d a dj u dicate d bef ore data base l oc k.  
S af et y A n al ysis Set ( S A F)  
All s u bj ects w h o si g n t he I C F a n d are treate d wit h t he i n vesti gati o nal 
treat me nt are c o nsi dere d e val ua ble as t he safet y p o p ulati o n. 
1 0. 3.   
St atistic al A n a l yses 
T he statistical a nal ysis pla n will be de vel o pe d a n d fi nalize d bef ore data bas e l oc k a n d will 
descri be t he partici pa nt p o p ulati o ns t o be i ncl u de d i n t he a nal ys es, a n d pr oce d ures f or acc o u nti n g 
f or missi n g, u n use d, a n d s p uri o us data. T his secti o n is a su m mar y of t he pla n ne d statistical 
a nal ys es of t he pri mar y a n d sec o n dar y e n d p oi nts.  
F or c o nti n u o us varia bles, descri pti ve statistics will i ncl u de t he f oll o wi n g: t he n u m ber of patie nts 
reflecte d i n t he cal c ulati o n ( n), mea n, me dia n, sta n dar d de viati o n, mi ni mu m, a n d ma xi m u m.  
F or cate g orical or or di nal data, fre q ue nci es a n d perce nta ges will be dis pla ye d f or eac h cate g or y.  
T he defi niti o n of pri mar y a n d sec o n dar y e n d p oi nts is descri be d i n Secti o n  4 . 
Safet y assess me nts will i ncl u de m o nit ori n g of A Es, vital si g ns, la b orat or y s afet y val ues, 
i nci de nce of w o u n d i nfecti o n-relate d e ve nts, a n d i m m u n ol o gic res p o nses t o Strata Graft.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 6  
C o nfi de ntial a n d Pr o prietar y  
T E A E is defi n e d as n e w or w orse ni n g A E after acti ve St u d y T x has bee n a d mi nistere d.  
S afet y assess me nts  
1.  I n ci de nce of T E A E t hr o u g h o ut st u d y 
2.  I n ci de nce of T E A E relat e d t o Strata Graft or A ut o grafti n g pr oce d ure   
3.  I n ci de nce of w o u n d i nfecti o n-relate d e ve nts at St u d y T x sites 
4.  Cli nicall y si g nifica nt c ha n ges i n vital si g ns t hr o u g h o ut st u d y c o m pare d t o Baseli ne  
5.  Cli nicall y si g nifica nt c ha n ges i n la b orat or y val u es bet wee n Bas eli ne a n d Da y 2 8  
1 0. 3. 1.   
A d v a nce me nt t o C o h ort 2  
F oll o wi n g e x cisi o n, a t otal of 2 0 s u bjects ( C o h ort 1) will be ra n d o mize d i nt o o ne of 2 gr o u ps:  
•  Gr o u p 1 s u bjects ( n = 1 0) will recei ve a ut o graft ( m es h rati o “ m”, c h ose n per 
cli nical j u d g me nt) c o m pare d t o m + 1: 1 mes he d a ut o graft o verlai d wit h Strata Graft  
•  Gr o u p 2 ( n = 1 0) will recei ve mes he d a ut o graft ( mes h rati o “ m”, per cli ni cal 
j u d g me nt) c o m p are d t o m + 2: 1 mes he d a ut o graft o verlai d wit h Strata Graft, 
a p plie d t o w o u n ds of 1 0 0 t o 4 0 0 c m 2 i n area.  
F oll o wi n g c o m pleti o n of t he Da y 2 8 assess me nts, eac h s u bject will be deter mi ne d t o be a s uccess 
or fail ure b ase d u p o n t he criteria b el o w:  
•  % cl ose d at D a y 2 8, wit h s uccess declare d if t he differe nce bet wee n paire d w o u n ds 
<  1 0 %, a n d  
•  T otal sc ore of O bser ver assess me nt of t he P O S A S at Da y 2 8, wit h s uccess d eclare d if 
t he differe nce b et wee n p aire d w o u n ds <  2 0 %.  
Gr o u p s uccess will be declare d  if > 8 0 % s u bjects are det er mi ne d t o ha ve treat me nt s uccess 
wit hi n t hat gr o u p. O nl y o ne of t he 2 S O M A T xs, m + 1 or m + 2, will be deter mi ne d t o meet t he a 
pri ori  esta blis he d criteria a b o ve a n d b ec o me t he S O M A T x i n C o h ort 2.  
1 0. 3. 2.   
Effic ac y A n al yses  
Efficac y a nal ys e s will be perf or me d c o m pari n g t h e differe nces bet wee n treat me nts wit hi n 
s u bjects, w here a p pr o priate. Descri pti ve s u m mari es will be re p orte d b y treat me nt site, mes h rati o 
o n S O M A T x site, c o h ort a n d o verall.  
F or calc ulate d perce nt re d ucti o n of d o n or s ki n (a s defi ne d b y [ 1-( A G T x mes h rati o/ S O M A T x 
mes h rati o)  ×  1 0 0]) at M o nt h 2, t he l o g -tra nsf or m ati o n of t he e n d p oi nt will be perf or me d, a n d 
ge o m etric mea n rati o perce nt re d u cti o n of d o n or s ki n bet wee n treat me nt site will be prese nt e d.  
I n a d diti o n, t he areas of treat me nt a n d d o n or sites will be s u m marize d. 
A mi x e d -effect m o del re peate d meas ures met h o d wit h c o variates, i ncl u di n g s u bject, treat me nt 
site, mes h rati o o n S O M A T x site, a n d c o h ort will be use d f or t his l o g-tra nsf or me d pri mar y 
e n d p oi nt.  
A nal ys is met h ods will be perf or me d o n t he F S A , per-pr ot oc ol s et, a n d als o o n all o bser ve d dat a.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 7  
C o nfi de ntial a n d Pr o prietar y  
T he s u m mar y statistics wit h 9 5 % c o nfi de nce i nter val, sta n dar d de vi ati o n, Least -s q uares mea ns 
a n d t he c orres p o n di n g sta n dar d err or will be pres e nte d f or treat me nt site, mes h rati o, c o h ort a n d 
o verall.  
If t he mi x e d-effect m o del re peate d m eas ures m o del d oes n ot c o n ver ge or vi olates t he m o del 
ass u m pti o ns, t he paire d t -test will be use d. If para metric statistics m o dels are n ot a p pr o priate, t he 
Wilc o x o n si g ne d -ra n k t est will be perf or me d. 
Gra p hs of Least -s q uares mea n ± sta n dar d err or a n d mea n ± sta n dar d de viati o n b y visit will be 
pr o vi de d.  
T he sa me a n al ysis met h o d will be use d f or sec o n dar y efficac y c o nti n u o us v aria bles  o n F S A .  
F or t he p aire d bi nar y  e n d p oi nt of differe nce i n perce nt of S O M A T x sites a n d A G T x sites wit h 
c o m plete w o u n d cl os ur e wit h o ut a d diti o nal a ut o grafti n g at M o nt h 2,  9 5 % c o nfi de nce i nter vals 
( CIs) of differe n ce are d eri ve d b y fitti n g a re peate d meas ures m o del wit h  P R O C G E N M O D t hat 
a dj usts f or t he c orrelati o n wit h pairs, a n d t he n t he 9 5 % CI of differe nce ca n be esti mate d usi n g 
t he Mar gi ns Macr o, pr o vi de d b y S A S. T he P-val u e will be deri ve d fr o m M c Ne mar’s test , if 
a p plica ble. 
T he descri pti ve statistics  will als o be p erf or me d b y treat me nt site, mes h rati o o n S O M A T x site, 
c o h ort a n d o verall a n d  o n F S A , per-pr ot oc ol set , a n d all o bser ve d dat a . The missi n g bi nar y data 
will be i m p ute d as n o n -res p o n ders. 
F or ot her paire d s ec o n dar y efficac y bi nar y e n d p oi nts, t he sa me a nal ys is as a b o ve will be use d o n 
F S A . 
1 0. 3. 3.   
S afet y A n al yses  
All safet y a nal yses will be perf or me d o n t he S A F.  
A Es/ T E A E will be c o de d usi n g Me dical Dicti o nar y f or Re g ulat or y Acti vities b y preferre d ter m 
wit hi n s yst e m or ga n cl ass. T he n u m ber of T E A E/ A Es, a n d t he n u m be r of s u bjects re p orti n g 
T E A E/ A Es will be liste d a n d s u m marize d b y b o d y s yste m, preferre d ter m, se verit y, a n d ca usalit y 
a n d b y M es h rati os, c o h ort a n d treat me nt sites. All seri o us A Es  (ie, S A Es) will be s u m marize d 
b y mes h rati os, c o h ort a n d treat me nt sites a n d narrati ves will be create d. O verall, t he  i nci de nce 
of w o u n d  i nfecti o n-relate d e ve nts will be liste d a n d s u m marize d b y mes h rati os, c o h ort, a n d 
treat me nt sites, if a p pr o priate. 
1 0. 3. 4.   
C o nc o mit a nt Me dic ati o n a n d Pr oce d ures  
All c o nc o mita nt me dicati o ns a n d pr oce d ures will be liste d b y s u bject. All c o nc o mita nt 
me dicati o ns will be s u m marize d b y treat me nt a n d d o n or sites. T he s yst e mic c o nc o mita nt 
me dicati o ns a wa y fr o m treat me nt a n d d o n or sites will be s u m marize d.  
1 0. 3. 5.   
I nteri m A n al yses  
See Secti o n 1 0. 3. 1 . 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 8  
C o nfi de ntial a n d Pr o prietar y  
1 1.    
R E F E R E N C E S  
Ale x a n der J W, Mac M illa n B G, La w E, Kitt ur D S. Treat me nt of se vere b ur ns wit h wi del y 
mes he d s ki n a ut o graft a n d mes h e d s ki n all o graft o verla y. J Tra u ma 1 9 8 1; 2 1( 6): 4 3 3 -8.  
Alle n -H off ma n n B L, Sc hl osser SJ, I v arie C A, et al. N or mal gr o wt h a n d differe ntiati o n i n a 
s p o nta ne o usl y i m m ortali ze d near-di pl oi d h u ma n kerati n oc yte cell li ne, NI K S. J I n vest D er mat ol 
2 0 0 0;  1 1 4: 4 4 4 -4 5 5 . 
A merica n B ur n Ass ociati o n. Nati o nal B ur n Re p osit or y 2 0 1 7 Re p ort of Data fr o m 2 0 0 8‐ 2 0 1 7. 
C hica g o, I L: A merica n B ur n Ass ociati o n, Dataset Versi o n 1 3. 0.  
Ce nta n ni J M, Strases ki J A, Wic ks A, Ha n k J A, et al. Strata Graft s ki n s u bstit ute is well t olerate d 
a n d is n ot ac utel y i m m u n o ge ni c i n patie nts wit h tra u matic w o u n ds: res ults fr o m a pr os pecti ve, 
ra n d o mize d, c o ntr olle d d ose escal ati o n trial. A n n S ur g 2 0 1 1; 2 5 3( 4): 6 7 2-8 3.  
F D A. G ui da n ce f or I n d ustr y: C hr o nic c ut a ne o us ul cer a n d b ur n w o u n ds –  de vel o pi n g pr o d ucts 
for treat me nt. J u ne 2 0 0 6.  
Her n d o n D N, Barr o w R E, R uta n R L, et al. A c o m paris o n of c o nser vati ve vers us earl y e xcisi o n 
t hera pies i n se verel y b ur ne d patie nts. A n n S ur g 1 9 8 9; 2 0 9( 5): 5 4 7-5 2.  
H ol mes J H, Sc h urr MJ, Ki n g B T, et al. A n o pe n -la bel, pr os pecti ve, ra n d omize d, c o ntr olle d, 
m ultice nter, p hase 1 b st u d y of Strat a Graft s ki n tiss ue vers us a ut o grafti n g i n patie nts wit h dee p 
partial -t hic k ness t her mal b ur ns. B ur ns 2 0 1 9; 4 5( 8): 1 7 4 9 -1 7 5 8 . 
Mc Der m ott K W, Weiss AJ, Eli x ha user A . B ur n -relate d h os pital i n patie nt sta ys a nd e mer ge nc y 
de part me nt visits , 2 0 1 3. H C U P Statistical Brief # 2 1 7. Dece m b er 2 0 1 6. A ge nc y f or Healt hcare 
Researc h a n d Q ualit y, R oc k ville, M D. htt p:// w w w. hc u p -us.a hr q. g o v/re p orts/stat briefs/s b 2 1 7 -
B ur n -H os pital -Sta ys -E D -Visits -2 0 1 3. p df. (accesse d 2 1 Oct 2 0 1 9).  
M uller MJ, Her n d o n D N. T he c halle n ge of b ur ns. La ncet 1 9 9 4;  3 4 3: 2 1 6 – 2 0.  
M u nster A M, S mit h -Mee k M, S har ke y P. T he effect of earl y s ur gical i nter ve nti o n o n m ortalit y 
a n d c ost -effecti ve ness i n b ur n care, 1 9 7 8 -9 1. B ur ns 1 9 9 4; 2 0: 6 1 – 4.  
Sc h urr MJ, F oster K N, C e nta n ni J M, et al. P hase I/II Cli nical E v al uati o n of Strata Graft: A 
C o nsiste nt, Pat h o ge n -Free H u ma n S ki n S u bstit ute. J Tra u ma 2 0 0 9;  6 6( 3): 8 6 6 -8 7 3.  
Wa y mac k P, D uff R G, Sa b oli ns ki M  a n d T he A pli graf B ur n St u d y Gr o u p. T he effect of a tiss ue 
e n gi n eere d bila yere d li vi n g s ki n a n al o g, o ver mes he d s plit -t hic k ness a ut o grafts o n t he heali n g of 
e x cise d b ur n w o u n ds. B ur ns 2 0 0 0; 2 6( 7): 6 0 9 -1 9.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
3 9  
C o nfi de ntial a n d Pr o prietar y  
1 2.    
A P P E N DI C E S  
A p pe n di x 1: A b bre vi ati o ns a n d Tr a de m ar ks  
A b bre vi ati o n or 
S peci al Ter m  
E x pl a n ati o n  
A E  
A d verse e ve nt  
A G  
A ut o graft –  a tra ns pla nt fr o m 1 l ocati o n t o a n ot her o n sa me pers o n 
A G T x  
A ut o graft treat me nt –  t he c o ntr ol st u d y treat me nt ar m recei vi n g t he tiss ue 
a p plicati o n of mes he d a ut o graft al o ne  
all o graft 
A tra ns pla nt fr o m 1 pers o n t o a n ot her pers o n  
a nti-B S A  
A nti -b o vi ne ser u m  al b u mi n 
CI  
C o nfi de nce i nter val  
C R F  
Case re p ort f or m  
D P T  
Dee p partial -t hic k ness 
D S M B  
Data a n d safet y m o nit ori n g b oar d 
e C R F 
Electr o nic case re p ort f or m  
F D A  
F o o d a n d Dr u g A d mi nistrati o n  
F S A  
F ull a nal ysis set  
F T  
F ull -t hic k ness 
G C P  
G o o d Cli nical Practice  
H C R U  
Healt h care res o urce utilizati o n  
I C F 
I nf or me d c o nse nt f or m 
I C H 
I nter nati o nal C o u ncil f or Har m o nisati o n 
I E C 
I n de pe n de nt Et hics C o m mittee 
I R B 
I nstit uti o nal re vie w b oar d 
P O S A S  
Patie nt a n d O bser ver Scar Assess me nt Scale  
P R A  
Pa nel reacti ve a nti b o dies 
P S A Q  
Patie nt Scar Assess me nt Q uesti o n naire  
P P S  
Per pr ot oc ol set  
S A E  
Seri o us a d verse e ve nt  
S A F  
Safet y a nal ysis set  
S O M A  
Strata Graft O verla y of Mes he d A ut o graft  
S O M A T x  
S O M A treat me nt - S trata Graft O verla y of M es he d A ut o graft ( S O M A), w here 
mes he d a ut o graft is c o vere d wit h Strata Graft a n d a p plie d t o a b ur n area  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
4 0  
C o nfi de ntial a n d Pr o prietar y  
A b bre vi ati o n or 
S peci al Ter m  
E x pl a n ati o n  
St u d y T x  
S O M A T x a n d t he c o ntr ol A G  T x  
T B S A  
T otal b o d y s urface area  
T E A E  
Treat me nt -e mer ge nt a d verse e ve nt  
W O C B P  
W o me n of c hil d beari n g p ote ntial  
 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
4 2  
C o nfi de ntial a n d Pr o prietar y  
A p pe n di x 3: St u d y G o ver n a nce C o nsi der ati o ns  
Re g ul at or y a n d Et hic al C o nsi der ati o ns  
•  T his st u d y will be c o n d u cte d i n acc or da nce wit h t he pr ot oc ol a n d t he f oll o wi n g:  
− C o nse ns us et hical pri nci ples deri ve d fr o m i nter nati o nal g ui deli nes i ncl u di n g t he 
Declarati o n of Helsi n ki a n d C o u ncil f or I nter nati o nal Or ga nizati o ns of Me dical 
Scie nces ( CI O M S) I nter nati o nal Et hical G ui deli nes  
− A p plica ble I C H G C P G ui deli nes  
− A p plica ble la ws a n d re g ulati o ns  
•  T he pr ot oc ol, pr ot oc ol a me n d me nts, I C F, I n vesti gat or Br oc h ure, a n d ot her rele va nt 
d oc u me nts ( e g, a d v ertise me nts) m ust be s u b mitte d t o a n I R B/ I n de pe n de nt Et hics 
C o m mittee ( I E C) b y t he i n vesti gat or a n d re vi e we d a n d a p pr o ve d b y t he I R B/I E C 
bef ore t h e st u d y is i nitiate d.  
•  A n y a me n d me nts t o t he pr ot oc ol will re q uire I R B/I E C a p pr o val bef ore 
i m ple me ntati o n of c ha n ges ma de t o t he st u d y desi g n, e xce pt f or c ha n ges necessar y t o 
eli mi nate a n i m me diate hazar d t o st u d y partici pa nts.  
•  T he i n vesti gat or will be res p o nsi ble f or t he f oll o wi n g:  
− Pr o vi di n g writte n s u m maries of t he stat us of t he st u d y t o t he I R B/I E C a n n uall y or 
m ore fre q u e ntl y i n acc or da nce wit h t he re q uire m e nts, p olicies, a n d pr oce d ures 
esta blis he d b y t h e I R B/I E C  
− N otif yi n g t he I R B/I E C of S A Es or ot her si g nifica nt safet y fi n di n gs as re q uire d b y 
I R B/I E C pr oce d ures 
− Pr o vi di n g o versi g ht of t h e c o n d uct of t he st u d y at t he site a n d a d here nce t o 
re q uire me nts of 2 1 C o de of Fe deral Re g ulati o ns ( C F R ), I C H g ui deli nes, t he 
I R B/I E C, E ur o pea n re g ul ati o n 5 3 6/ 2 0 1 4 f or cli nical st u dies (if a p plica ble), a n d all 
ot her a p plica ble l o ca l re g ulati o ns 
Fi n a nci al Discl os ure  
I n v esti gat ors a n d s u b-i n v esti gat ors will pr o vi de t he s p o ns or wit h s ufficie nt, acc urate fi n a ncial 
i nf or mati o n as re q u este d t o all o w t he s p o ns or t o s u b mit c o m plete a n d acc urate fi na ncial 
certificati o n or discl os ure state me n ts t o t he a p pr o priate re g ul at or y a ut h orities. I n vesti gat ors are 
res p o nsi ble f or pr o vi di n g i nf or mati o n o n fi na ncial i nterests d uri n g t h e c o urse of t he st u d y a n d f or 
1 year after c o m pleti o n of t he st u d y.  
I nf or me d C o nse nt Pr ocess 
•  T he i n vesti gat or or his/ her r e prese nt ati ve will e x plai n t he nat ure of t he st u d y t o t he 
partici pa nt or his/ her le gall y a ut h orize d re pres e nt ati ve a n d a ns wer all q uesti o ns 
re gar di n g t he st u d y.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
4 3  
C o nfi de ntial a n d Pr o prietar y  
•  Partici pa nts m ust be i nf or me d t hat t heir partici p ati o n is v ol u ntar y. Partici pa nts or 
t heir le gall y a ut h orize d re prese nt ati ve will be re q uire d t o si g n a stat e me nt of i nf or me d 
c o nse nt t hat meets t he re q uire me nts of 2 1 C F R 5 0, l ocal re g ulati o ns, I C H g ui deli nes, 
Healt h I ns ura nce P orta bilit y a n d Acc o u nta bilit y Act ( HI P A A) re q uire me nts, w here 
a p plica ble, a n d t h e I R B/I E C or st u d y ce nter.  
•  T he me dical rec or d m ust i ncl u de a state me nt t hat writte n i nf or me d c o ns e nt was 
o btai ne d bef ore t he partici pa nt was e nr olle d i n t he st u d y a n d t he date t he writte n 
c o nse nt was o btai ne d. T h e a ut h orize d pers o n o btai ni n g t he i n f or m e d c o nse nt m ust 
als o si g n t he I C F.  
•  Partici pa nts m ust be re -c o nse nte d t o t he m ost c urre nt versi o n of t he I C F(s) d uri n g 
t heir partici pati o n i n t he st u d y.  
•  A c o p y of t he I C F(s) m ust be pr o vi de d t o t he partici pa nt or t he partici pa nt’s le gall y 
a ut h orize d repres e ntati ve.  
D at a Pr otecti o n  
•  Partici pa nts will be assi g ne d a u ni q ue i de ntifier b y t he s p o ns or. A n y partici pa nt 
rec or ds or datasets t hat are tra nsferre d t o t he s p o ns or will c o ntai n t he i de ntifier o nl y; 
partici pa nt na mes or a n y i nf or mati o n w hic h w o ul d ma ke  t he partici p a nt i de ntifia ble 
will n ot be tra nsferre d.  
•  T he partici pa nt m ust be i nf or me d t hat his/ her pers o nal st u d y -relate d data will be use d 
b y t he s p o ns or i n acc or da nce wit h l ocal data pr otecti o n la w. T he le vel of discl os ure 
m ust als o be e x plai ne d t o t h e partici pa nt.  
•  T he partici pa nt m ust be i nf or me d t hat his/ her me dical rec or ds ma y be e xa mi ne d b y 
Cli nical Q ualit y Ass ura n ce a u dit ors or ot her a ut h orize d pers o n nel a p p oi nte d b y t he 
s p o ns or, b y a p pr o priat e I R B/I E C me m bers, a n d b y i ns pect ors fr o m re g ulat or y 
aut h orities.  
C o m mittees Str uct ure  
A n i n de pe n de nt D S M B will be c o n ve ne d i n or der t o e ns ure t hat t he safet y of s u bjects is 
a de q uatel y pr otecte d. T h e D S M B o bjecti ves, c o m p ositi o n, a n d o perati o nal details of its acti vities 
will be defi ne d i n t he D S M B C harter.  
P u blic ati o n P olic y  
•  T he res ults of t his st u d y ma y be p u blis he d or pres e nte d at scie ntific meeti n gs. If t his 
is f oresee n, t h e i n vesti gat or a grees t o s u b mit all ma n uscri pts or a bstracts t o t he 
s p o ns or bef ore s u b missi o n. T his all o ws t he s p o ns or t o pr otect pr o pri etar y i nf or mati o n 
a n d t o pr o vi de c o m me nts.   
•  T he s p o ns or will c o m pl y wit h t he re q uire me nts f or p u blicati o n of st u d y res ults. I n 
acc or da nce wit h sta n dar d e dit orial a n d et hical practice, t he s p o ns or will ge nerall y 
s u p p ort p u blicati o n of m ultice nter st u dies onl y i n t heir e ntiret y a n d n ot as i n di vi d ual 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
4 4  
C o nfi de ntial a n d Pr o prietar y  
site data. I n t his case, a c o or di nati n g i n vesti gat or will be desi g nat e d b y m ut ual 
a gree m e nt.  
•  A ut h ors hi p will be deter mi ne d b y m ut ual a gree m e nt a n d i n li ne wit h I nt er nati o nal 
C o m mittee of Me dical J o ur nal E dit ors a ut h ors hi p re q uire me nts.  
D at a Q u alit y Ass ur a nce  
•  All partici pa nt data relati n g t o t he st u d y will be rec or de d o n pri nte d or electr o nic C R F 
u nless tra ns mitte d t o t he s p o ns or or desi g nee electr o nicall y ( e g, la b orat or y data). T he 
i n vesti gat or is res p o nsi ble f or verif yi n g t hat data e ntries are acc urate a n d c orrect b y 
p h ysicall y or electr o ni call y si g ni n g t he C R F.  
•  T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce data) t hat s u p p orts 
t he i nf or mati o n e ntere d i n t he C R F.  
•  T he i n vesti gat or m ust per mit st u d y -rel ate d m o nit ori n g, a u dits, I R B/I E C re vie w, a n d 
re g ulat or y a ge nc y i ns pecti o ns a n d pr o vi de direct access t o s o urce data d oc u me nts.  
•  T he s p o ns or or desi g nee is res p o nsi ble f or t he dat a ma na ge m e nt of t his st u d y 
i ncl u di n g q ualit y c hec ki n g of t he data.  
•  St u d y m o nit ors will perf or m o n g oi n g s o urce data verificati o n t o c o nfir m t hat data 
e ntere d i nt o t he C R F b y a ut h orize d site pers o n nel are acc urate, c o m plete, a n d 
verifia ble fr o m s o urce d o c u me nts; t hat t he safet y a n d ri g hts of part ici pa nts are bei n g 
pr otecte d; a n d t hat t he st u d y is bei n g c o n d ucte d i n acc or da nce wit h t he c urre ntl y 
a p pr o ve d pr ot o c ol a n d a n y ot her st u d y a gree me nts, I C H G C P, a n d all a p plica ble 
re g ulat or y re q uire me nts.  
•  All rec or ds, s o urce d o c u me nts, st u d y w or ks heets, si g ne d I C Fs, a n d a n y ot h er 
d oc u me nts pertai ni n g t o t he c o n d uct of t his st u d y m ust be retai ne d b y t he i n vesti gat or 
f or at least 2 years after st u d y c o m pleti o n or a p pr o val of t he dr u g, w hic he ver c o mes 
last, u nless l ocal re g ulati o ns or i nstit uti o nal p olicies req uire a l o n ger rete nti o n peri o d. 
( U S 2 1 C F R § 3 1 2. 6 2). N o rec or ds ma y be destr o ye d d uri n g t he rete nti o n peri o d 
wit h o ut t he writte n a p pr o val of t he s p o ns or. N o rec or ds ma y be tra nsferre d t o a n ot her 
l ocati o n or part y wit h o ut writte n n otificati o n t o t he s p o ns or.  
S o urce D oc u me nts  
•  S o urce d oc u me nts pr o vi d e e vi de nce f or t h e e xiste nce of t he partici pa nt a n d 
s u bsta ntiate t he i nte grit y of t he data c ollecte d. S o urce d oc u m e nts are file d at t he 
i n vesti gat or’s site. 
•  Data re p orte d o n t he C R F or e ntere d i n t he e C R F t hat are tra nscri be d fr o m s o urce 
d oc u me nts m ust be c o nsiste nt wit h t he s o urce d oc u me nts or t he discre pa ncies m ust be 
e x plai ne d. T he i n vesti gat or ma y nee d t o re q uest pre vi o us me dical rec or ds or tra nsfer 
rec or ds, de pe n di n g o n t h e st u d y. Als o, c urre nt me dical rec or ds m ust be a vaila ble.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
4 5  
C o nfi de ntial a n d Pr o prietar y  
St u d y a n d Site Cl os ure  
T he s p o ns or desi g nee res er ves t he ri g ht t o cl ose t h e st u d y site or ter mi nate t he st u d y at a n y ti me 
f or a n y reas o n at t he s ole discreti o n of t he s p o ns or. St u d y sites will be cl ose d u p o n st u d y 
c o m pleti o n. A st u d y sit e is c o nsi dere d cl ose d w he n all re q uire d d oc u me nts a n d st u d y s u p plies 
ha ve bee n c ollecte d a n d a st u d y -site cl os ure visit has bee n perf or me d. 
T he i n vesti gat or ma y i nitiate st u d y -site cl os ure at a n y ti me, pr o vi d e d t here is reas o na ble ca use 
a n d s ufficie nt n ot ice is gi ve n i n a d va nce of t he i nt e n de d ter mi nati o n. 
Reas o ns f or t he earl y cl os ure of a st u d y site b y t he s p o ns or or i n vesti gat or ma y i ncl u de b ut are 
n ot li mite d t o:  
•  Fail ure of t he i n vesti gat or t o c o m pl y wit h t he pr ot oc ol, t he re q uire me nts of t he 
I R B/I E C or l ocal h ealt h a ut h orities, t he s p o ns or's pr oce d ures, or G C P g ui deli nes 
•  I n a de q uat e recr uit me nt of partici pa nts b y t he i n vesti gat or 
•  Disc o nti n uati o n of f urt her st u d y treat me nt de vel o p me nt  
 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
5 2  
C o nfi de ntial a n d Pr o prietar y  
A p pe n di x  5: C o ntr ace pti ve G ui d a nce a n d C ollecti o n of Pre g n a nc y 
I nf or m ati o n 
W o m a n of C hil d be ari n g P ote nti al ( W O C B P)  
A w o ma n is c o nsi dere d fertile f oll o wi n g m e narc he a n d u ntil bec o mi n g p ost -me n o pa usal u nless 
per ma ne ntl y sterile.  
Fe males w h o are p ost me n o pa usal a ge b ut are als o o n H R T a n d w h ose me n o pa usal stat us is i n 
d o u bt will be re q uire d t o use o ne of t he n o n-h or m o nal hi g hl y effecti ve c o ntrace pti o n met h o ds if 
t he y wis h t o c o nti n ue t heir H R T d uri n g t he st u d y. Ot her wise, t he y m ust disc o nti n ue H R T t o 
all o w c o nfir mati o n of n o n -W O C B P bef ore st u d y e nr oll me nt.  
N o n -W O C B P St at us  
•  Pre me narc h al  
•  Per ma ne ntl y  st erile fe male is a pre me n o pa usal fe male wit h 1 of t he f oll o wi n g:  
− D oc u me nte d h ysterect o m y  
− D oc u me nte d bilateral sal pi n gect o m y  
− D oc u me nte d bilateral o o p h orect o m y  
N ote: D oc u me ntati o n ca n c o me fr o m t he site pers o n nel’s: re vie w of t he 
partici pa nt’ s me dical rec or ds, me dical e xa mi nati o n, or me dical hist or y i nter vie w.  
•  A p ost me n o pa usal state is defi ne d as n o me ns es f or 1 2 m o nt hs wit h o ut a n alter nati ve 
me dical ca us e. A hi g h f ollicle sti m ulati n g h or m o ne ( F S H) l e vel i n t he 
p ost me n o pa usal ra n ge m a y be use d  t o c o nfir m a p ost me n o pa usal state i n w o me n n ot 
usi n g h or m o nal c o ntrace pti o n or h or m o nal re place me nt t hera p y ( H R T). N ote t hat i n 
t he a bse nce of 1 2 m o nt hs of a me n orr hea, a si n gl e F S H meas ure me nt is i ns ufficie nt.  
Pre g n a nc y Testi n g  
Fe male p artici pa nts of c hil d beari n g p ot e ntial are eli gi ble t o partici pate i n t his st u d y. All w o me n 
of c hil d beari n g p ote ntial will be teste d f or pre g na nc y a n d if f o u n d t o be pre g na nt, will be 
e x cl u de d fr o m partici pati o n.  

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
5 3  
C o nfi de ntial a n d Pr o prietar y  
C ollecti o n of Pre g n a nc y I nf or m ati o n   
Fe m ale P artici p a nts w h o bec o me pre g n a nt  
•  T he i n vesti gat or will c ollect pre g na nc y i nf or m ati o n o n a n y fe male partici pa nt w h o 
bec o mes pre g na nt w hile partici pati n g i n t his st u d y. I nf or mati o n will be rec or de d o n 
t he a p pr o priat e f or m a n d s u b mitte d t o t he s p o nsor wit hi n 2 4 h o urs of lear ni n g of a 
partici pa nt's pre g n a nc y. T he partici pa nt will be f oll o we d t o deter mi ne t he o utc o me of 
t he pre g na n c y. T he i n vesti gat or will c ollect f oll o w-u p i nf or mati o n o n t he partici pa nt 
a n d t he ne o nat e a n d t he i nf or mati o n will be f or w ar de d t o t he s p o ns or. Ge nerall y, 
f oll o w-u p will n ot be re q uire d f or l o n ger t ha n 6 t o 8 wee ks be y o n d t h e esti mate d 
deli ver y date. A n y t er mi nati o n of pre g na nc y will be re p orte d, re gar dless of fetal 
stat us ( prese n ce or a bse n ce of a n o m alies) or i n dicati o n f or t he pr oce d ure. 
•  W hile pre g na n c y itself is n ot c o nsi dere d t o be a n A E or S A E, a n y pre g na nc y 
c o m plicati o n or electi ve t er mi nati o n of a pre g na nc y will be re p orte d as a n A E or 
S A E. A s p o nta ne o us a b orti o n is al wa ys c o nsi dere d t o be a n S A E a n d will be re p orte d 
as s uc h. A n y p ost-st u d y, pre g na nc y-rel ate d S A E c o nsi dere d reas o na bl y relate d t o t he 
st u d y treat me nt b y t h e i n vesti gat or will be re p orte d t o t he s p o ns or. W hile t he 
i n vesti gat or is n ot o bli gate d t o acti vel y see k t his i nf or mati o n i n f or mer st u d y 
partici pa nts, h e or s he ma y l ear n of a n S A E t hr o u g h s p o nta ne o us re p orti n g.  
•  A n y fe male p artici pa nt w h o bec o mes pre g na nt w hile partici pati n g i n t he st u d y will 
c o nti n ue wit h all sc he d ul e d st u d y e val uati o ns. Pre g na nt s u bjects will be f oll o we d 
u ntil p ost -part u m a n d t he o utc o m e of t he pre g na nc y will be re p orte d.  
 

Cli nical Pr ot oc o l M N K 0 1 0 6 2 1 1 7 
Strata Graft  
A me n d me nt 5  
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
 
5 4  
C o nfi de ntial a n d Pr o prietar y  
A p pe n di x 6: C o u ntr y -s pecific Re q uire me nts  
T his st u d y is pla n ne d f or cli nical sites i n t he U S A t hat a d here t o I C H g ui d a nces a n d G C P. N o 
c o u ntr y-s pecific re q uire me nts f urt her affect t his st u d y pr ot oc ol. 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt 5  
 
5 5  
C o nfi de ntial a n d Pr o prietar y  
A p pe n di x  7: Pr ot oc ol A me n d me nt Hist or y  
T he S u m mar y of C ha n ges prese nte d bel o w i n  Ta ble  2  reflects t he c ha n ges ma de i n A me n d me nt 5  a n d a hi g h -le vel s u m mar y of t he 
reas o n(s). F or matti n g, c o nsiste nc y, a n d mi n or e dit orial c ha n ges are n ot des cri be d .  
T a ble  2 :   
S u m m ar y of C h a n ges  
F or matti n g, c o nsiste nc y, a n d mi n or e dit orial c ha n ges are n ot liste d.  
 
Pr ot oc ol secti o n    
Re m o ve d te xt i n stri ket hr o u g h  a n d ne w te xt i n b ol d  
Iss ue/r ati o n ale f or c h a n ge 
S u m mar y of C ha n ges f or 
A me n d me nts  
 
A me n d me nt 4 5  i ncl u des c ha n ges rel ate d t o t he st u d y ti meli ne, i de ntificati o n 
F D A’s re visi o n  of  a d verse e ve nts of s pecial i nterest ( A E SI), A d verse E ve nt 
Ca usalit y assess me nt  t he xe n otr a ns pl a nt ati o n re q uire me nts  f or Str at a Gr aft 
a n d S A E/ A E SI re p orti n g ti meli ne  as o utli ne d i n A p pe n di x 7, w hic h pr o vi des a 
mi n or  a d mi nistr ati ve cl arific ati o ns. A c o m plete s u m mar y of  t he c ha n ge s 
reflecte d i n  t his pr ot oc ol is pr o vi de d i n A p pe n di x 7.  
I de ntifies t he reas o n f or c ha n ges 
a n d l ocati o n of a c o m plete 
s u m mar y of c ha n ges. U p date d 
f or c urre nt Pr ot oc ol A me n d me nt. 
Ta ble  1 , F o ot n ote f 
f Bli n de d assess or will assess all treat me nt sites f or perce nt re -e pit helializati o n 
be gi n ni n g at Da y 7 a n d t he n dail y, or as ofte n as p ossi ble, d uri n g dressi n g 
c ha n ges, u ntil c o m plete cl os ure , a n d t he n is o bser ve d. A sec o n d o bser v ati o n 
of c o m plete cl os ure a t le ast 2 wee ks after t he i niti al o bser v ati o n is re q uire d 
t o c o nfir m cl os ure. T here after, m ai nte n a nce of cl os ure will be assesse d at 
eac h st u d y visit, t o assess d ura bilit y of cl os ure.  
Clarif y defi niti o ns of c o nfir me d 
c o m plete cl os ure a n d d ura ble 
cl os ure. 
 
 
 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt 5  
 
5 6  
C o nfi de ntial a n d Pr o prietar y  
Pr ot oc ol Secti o n    
Re m o ve d te xt is stri ket hr o u g h a n d ne w test is i n b ol d  
Iss ue/r ati o n ale f or c h a n ge 
Secti o n  3. 3  
Res ults t o date i n dicate t hat Strata Graft is well t olerate d a n d n o cli nicall y 
o bser va ble all o ge neic i m m u ne res p o nses ha ve bee n re p orte d. T he m ost 
c o m m o n n ote d a d verse reacti o n ass ociate d wit h  Strata Graft treat me nt is 
pr uritis.  
 
T he oretical ris ks s pecific t o Strata Graft treat me nt i ncl u de de vel o p me nt of a n 
i m m u ne res p o nse t o t he all o ge neic cells of Strata Graft, a n d  t he nee d f or 
s u bse q ue nt a ut o grafti n g of t he Strata Graft treat me nt site, a n d t he ris k of 
e x p os ure t o a xe n o ge neic s o urce d i nfecti o us a ge nt . Bec a use Str at a Gr aft 
c o nt ai ns h u m a n cells, t here is t he p ossi bilit y of tr a ns missi o n of a n 
i nf ecti o us a ge nt. A d diti o n all y, Str at a Gr aft c o nt ai ns gl yceri n, t heref ore i n 
p atie nts w h o h a ve a gl yceri n se n siti vit y, t here is a ris k of a n aller gic 
re acti o n.  
 
W hile n o cli nicall y rele va nt i m m u ne res p o nse t o Strata Graft has bee n see n i n 
S T R A T A 2 0 0 1, S T R A T A 2 0 1 1, S T R A T A 2 0 1 4 or S T R A T A 2 0 1 6, or t here is a 
t he oretical p ossi bilit y t hat s u bj ects w h o m o u nt a n i m m u ne res po nse t o t he 
all o ge neic cells of Strata Graft a n d w h o t he n bec o me ca n di dates f or recei vi n g 
s oli d or ga n tra ns pla nts c o ul d e x perie nce of narr o wi n g of t he s uita ble d o n or 
p o ol.  
 
Data fr o m S T R A T A 2 0 0 1 s h o we d t he a ut o graft ta ke after treat me nt of t he 
w o u n d be d wit h  Strata Graft was si milar t o ca da ver all o graft, 9 7 % a n d 9 6 %, 
res pecti vel y.  A d diti o nall y, t he 2 S T R A T A 2 0 1 1, t he 3 S T R A T A 2 0 1 4 a n d t he 3 
S T R A T A 2 0 1 6 s u bjects w h o recei ve d a ut o graft at sites pre vi o usl y treate d wit h 
Strata Graft s h o we d c o m plete w o u n d cl os ure bef o re or at M o nt h 3, 
de m o nstrati n g t hat treat me nt wit h Strata Graft d oes n ot i m pe de ac hie ve me nt of 
w o u n d cl os ure i n t he e ve nt a ut o graft is use d t o ac hie ve defi niti ve cl os ure.  
 
Reflects m o dificati o ns of t he 
xe n otra ns pla ntati o n pr o d uct 
pr o hi biti o ns/re q uire me nts f or 
Strata Graft as gra nte d b y t he U S 
F D A  
 
 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt 5  
 
5 7  
C o nfi de ntial a n d Pr o prietar y  
Pr ot oc ol Secti o n  
Re m o ve d te xt is stri ket hr o u g h a n d ne w test is i n b ol d  
Iss ue/r ati o n ale f or c h a n ge 
Secti o n  3. 3  
T he last t he oretical ris k t hat of a xe n o ge neic res p o nse, is d ue t o a n hist oric 
e x p os ure of t he NI K S kerati n oc ytes t o li ve m uri ne cells d uri n g i n vitr o c ult ure. 
NI K S kerati n oc ytes were i nitial l y is olate d a n d e x pa n de d o n re plicati o n 
i nacti vate d m uri ne 3 T 3 M 1 cells t hat ser ve d as a s o urce of fact ors s u p p orti n g 
cell ular gr o wt h. T hese “fee der cells” were t h or o u g hl y teste d , s h o w n t o be free 
of all teste d diseases, a n d are n o l o n ger use d t o s u p p ort t h e gr o wt h of t he NI K S 
kerati n oc ytes, n or use d i n t he ma n ufact uri n g pr ocess.  
 
Strata Graft is a n all o ge neic, cell ularize d scaff ol d pr o d uct.  T he c o nstr uct 
c o nsists of differe ntiate d e pi der mal la yer of h u ma n kerati n oc ytes ( near di pl oi d 
h u ma n kerati n oc ytes ( NI K S) gr o w n o n a der mal la yer of gelle d c olla ge n 
e m be d de d wit h n or mal h u ma n der mal fi br o blasts.  
Str at a Gr aft is a xe n otr a ns pl a nt ati o n pr o d uct bec a use i n t he p ast, o ne of 
t he cell t y pes use d t o m a ke Str at a Gr aft w as gr o w n wit h m o use cells. T he 
cell b a n ks h a v e bee n teste d a n d f o u n d t o be free of detect a ble i nf ecti o us 
a ge nts a n d m o use cells are n o l o n ger use d i n t he m a n uf act ure of 
Str at a Gr aft. T here h a ve bee n n o i de ntifie d he alt h c o ncer ns ass oci ate d wit h 
t hese m o use cells.  
 
Reci pie nts of xe n otr a ns pl a nt ati o n pr o d ucts are ge ner all y n ot eli gi ble , per 
fe der al re g ul ati o ns, t o d o n ate w h ole bl o o d, bl o o d c o m p o ne nts, s o urce 
pl as m a or s o urce le u k oc ytes. H o we ver, i n di vi d u al bl o o d b a n ks m a y re q uest 
a n e xce pti o n  f r o m F D A. Str at a Gr aft reci pie nts wis hi n g t o d o n ate bl o o d or 
bl o o d pr o d ucts s h o ul d c hec k wit h t heir d o n ati o n ce nter.  Str at a Gr aft 
reci pie nts w h o ot her wise meet t he d o n or re q uire me nts are eli gi ble t o 
d o n ate h u m a n cells, tiss ues, bre ast mil k, o v a, s per m or b o d y p arts f or 
tr a ns pl a nt ati o n. 
 
 
Reflects m o dificati o ns of t he 
xe n otra ns pla ntati o n pr o d uct 
pr o hi biti o ns/re q uire me nts f or 
Strata Graft as gra nte d b y t he U S 
F D A  
 
 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt 5  
 
5 8  
C o nfi de ntial a n d Pr o prietar y  
Pr ot oc ol Secti o n  
Re m o ve d te xt is stri ket hr o u g h a n d ne w te xt is i n b ol d  
Iss ue/r ati o n ale f or c h a n ge 
Secti o n  1  a n d Secti o n  4     
(Wit hi n C o -Pri mar y E n d p oi nts ) 
•  
 Differe nce i n perce nt of S O M A T x sites a n d A G T x sites wit h c o nfir me d 
c o m plete w o u n d cl os ure wit h o ut a d diti o nal a ut o grafti n g at M o nt h 2  
(Wit hi n Sec o n dar y E n d p oi nts ) 
•  
 I nci de nce of c o nfir me d  c o m plete w o u n d cl os ure of t he St u d y T x sites at 
Da ys 1 4, 2 1, 2 8, a n d 4 2, M o nt h 2 a n d M o nt h 3  
Clarif y t hat e n d p oi nts i ncl u de 
c o nfir me d c o m plete w o u n d 
cl os ure, n ot si m ple cl os ure  
Secti o n  5. 6   
I n t his st u d y, safet y will be m o nit ore d b y t he Me dical M o nit or a n d Gl o bal 
Safet y Lea d fr o m t he S p o ns or, as well as t he Data Safet y M o nit ori n g B oar d 
( D S M B). T he D S M B will be i n de pe n de nt of st u d y c o n d uct.  S u bject e nr oll me nt 
will be pa use d pe n di n g disc ussi o n wit h D S M B if a n y of t he f oll o wi n g occ ur : 
 
•  
I nfectio n  U ne x pecte d i nf ecti o n  at t he Strata Graft treate d site attri b ute d  
t h at is p ossi bl y or pr o b a bl y rel ate d t o Strata Graft a n d is a n S A E  
•  
Se vere ac ute h y perse nsiti vit y reacti o n attri b ute d t o Strata Graft  
•  
Deat h attri b ute d t o Strata Graft  
Clarifie d t he t y pe of i nfecti o n 
t hat merits a n A d verse E ve nt of 
S pecial I nterest  
Secti o n  7. 1   
D osa ge f or m ulati o n : 
 
Strata Graft is a na vi a ble a n d met a b olic all y acti ve  all o ge neic , h u m a n NI K S 
ker ati n oc ytes a n d h u m a n der m al fi br o bl asts  cell ularize d l a yere d scaff ol d 
pr o d uct . It is gr o w n  s up plie d  i n a recta n g ular, 1 0 0 c m2 f or mat, a n d s u p plie d 
l o osel y a d here nt t o a p ol ycar b o nate me m bra ne of a tiss ue i nsert. Strata Graft is 
st ore d at -7 0° C  t o -9 0° C u ntil t ha we d f or use.  
 
Pac ka gi n g a n d La beli n g : 
 
Strata Graft is a cr y o preser ve d, sterile, crea m c ol ore d, recta n g ular, li vi n g s ki n 
e q ui vale nt wit h a s urface area of a p pr o xi matel y 1 0 0 c m 2 per u nit t hat ma y be 
mes he d, sta ple d, gl ue d a n d/ or s ut ure d.  
Ali g n descri pti o n  wit h t he 
pac ka ge i nsert  
 
 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt 5  
 
5 9  
C o nfi de ntial a n d Pr o prietar y  
Pr ot oc ol secti o n    
Re m o ve d te xt i n stri ket hr o u g h a n d ne w te xt i n b ol d 
Iss ue/r ati o n ale f or c h a n ge 
Secti o n  7. 5   
Strata Graft will be s u p plie d fr oze n t o t he I n vesti gat or i n a n a p pr o priate s hi p per. 
T he i n vesti gat or or desi g nee m ust c o nfir m a p pr o priate te m perat ure c o n diti o ns 
ha ve bee n mai ntai ne d d uri n g st ora ge a n d tra nsit f or all St u d y T x recei ve d a n d 
a n y discre pa ncies are re p orte d a n d res ol ve d bef ore use of t he St u d y T x.  
O nce recei ve d a n d eac h Strata Graft piece l o g ge d, t he pr o d uct will be st ore d i n a 
sec ure, e n vir o n me ntall y c o ntr olle d a n d m o nit ore d ( ma n ual or a ut o mate d) area 
i n acc or da nce wit h t he la bele d st ora ge c o n diti o ns wit h access li mite d t o t he 
i n vesti gat or a n d a ut h orize d site staff. 
 
Str at a Gr aft will be s hi p pe d t o t he st u d y site o n dr y ice. U p o n arri v al, 
Str at a Gr aft m a y be m ai nt ai ne d i n t he se ale d s hi p pi n g c o nt ai ner u ntil t he 
d ate a n d ti me i n dic ate d o n t his c o nt ai ner. If t he Str at a Gr aft will n ot be 
use d u ntil after t he d ate a n d ti me i n dic ate d o n t he s hi p pi n g c o nt ai ner, u p o n 
arri v al at t he site, Str at a Gr aft s h o ul d be tr a nsferre d f r o m t he s hi p pi n g 
c o nt ai ner t o a sec ure, ultr a -c ol d (-7 0 °C t o -9 0 °C) freezer wit h m o nit ore d 
te m per at ure. O nce Str at a Gr aft h as bee n recei ve d at t he site, a n d 
tr a nsferre d i nt o a site’s ultr a-c ol d f reezer, a n y e xc ursi o n fr o m re q uire d 
st or a ge r a n ge m ust be re p orte d t o t he S p o ns or as s o o n as it bec o mes k n o w n 
a n d pri or t o cli nic al use. O nl y s u bj ects e nr olle d i n t he st u d y ma y recei ve 
St u d y T x a n d o nl y a ut h orize d site sta ff ma y s u p pl y or a d mi nister St u d y T x. 
 
U p date s hi p pi n g a n d recei pt of 
Strata Graft.  
 
 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt 5  
6 0  
C o nfi de ntial a n d Pr o prietar y  
Pr ot oc ol secti o n    
Re m o ve d te xt i n stri ket hr o u g h a n d ne w te xt i n b ol d  
Iss ue/r ati o n ale f or c h a n ge 
Secti o n  9. 2. 5  
A n a d verse e ve nt A d verse E ve nt  of s pecial i nterest (S peci al I nterest  ( A E SI), 
w het her  seri o us or n o n-seri o us), is o ne of scie ntific a n d me dical c o ncer n 
s pecific t o t he s p o ns or’s pr o d uct or pro gra m, f or w hic h o n g oi n g m o nit ori n g a n d 
ra pi d c o m m u nicati o n b y t he i n vesti gat or t o t he s p o ns or ca n be a p pr o priate.  
A d verse E ve nts of S peci al I nterest  ( A E SI) will be re p orte d usi n g t he 
S A E/ A E SI Re p ort F or m a n d o bser ve t he sa me re p orti n g ti meli ne ( A p pe n di x 4).  
F or t his st u d y, A d verse E ve nts of S pecial I nterest ( A E SI ) i ncl u de: 
• 
U ne x pecte d or u n us ual i nfecti o ns
• 
Der mat ol o gical mali g na nc y
• 
A n y xe n otra ns pla ntati o n relate d a d verse e ve nt or cli nical e ve nt t hat is
s us pici o us of a xe n o ge neic ca use, e. g. disease/ dis order of k n o w n 
z o o n otic ori gi n. 
Clarificati o n of la n g ua ge , a n d 
reflects m o dificati o ns of t he 
xe n otra ns pla ntati o n pr o d uct 
pr o hi biti o ns/re q uire me nts f or 
Strata Graft as gra nte d b y t he U S 
F D A  

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt 5  
 
6 1  
C o nfi de ntial a n d Pr o prietar y  
Pr ot oc ol secti o n    
Re m o ve d te xt i n stri ket hr o u g h a n d ne w te xt i n b ol d  
Iss ue/r ati o n ale f or c h a n ge 
Secti o n  9. 2. 6. 1   
St u d y T x sites will be e xa mi ne d b y t he i n vesti gat or at eac h visit f or si g ns of 
s ki n d yscrasias, s uc h as vesicle or b ullae f or mati o n, irritati o n, ras h, dr y ness as 
well as si g ns of i nfecti o n. A n y n ote d iss ue will be re p orte d as a n A E.  
L ocal St u d y T x site i nfecti o n will be deter mi ne d b y t he cli nical i n vesti gat or a n d 
ma y i ncl u de c o nfir mat or y micr o bi ol o gical assess me nt. Si milarl y, s yste mic 
i nfecti o n will be deter mi ne d b y t he cli nical i n vesti gat or a n d ma y i ncl u de 
d oc u me ntati o n of s uc h si g ns as p ositi ve bl o o d c ult ures, fe ver ( defi ne d as 
> 3 8. 5 oC) a n d/ or ele vate d w hite bl o o d cell c o u nt. C ult ures of t he treat me nt sites 
ma y be o btai ne d f or micr o bi ol o gical e val uati o n at t he discreti o n of t he cli nical 
i n vesti gat or or per i nstit uti o nal Sta n dar d of Care at a n y ti me d uri n g st u d y 
treat me nt. T he cli nical i n vesti gat or will e val uate t he w o u n d c ult ure res ults f or 
i nfecti o ns a n d t heir treat me nt will be d oc u me nte d i n t he electr o nic case re p ort 
f or m (e C R F) wit h n otati o n of s pecific l ocati o n of t he i nfecti o n.  
At i n vesti g at or discreti o n, tre at me nt of i nf ecte d/s us pecte d i nfecte d w o u n d 
sites m a y i ncl u de t he use of t ar gete d w o u n d cle a nsi n g a ge nts, t o pic al 
a nti micr o bi al a ge nts a n d/ or s yste mic a nti bi otics. St u d y w o u n d sites m a y 
n ot be tre ate d wit h a n y pr o hi bite d t her a pies, as o utli ne d i n  Secti o n  7. 7. 3 . 
 
Clarifie d i nstr ucti o ns relate d t o 
treat me nt of i nfecti o ns. Li n ke d 
t o P r o hi bite d Me dicati o ns a n d 
T hera pies  secti o n. 
 
 

Cli nical Pr ot oc ol M N K 0 1 0 6 2 1 1 7  
Strata Graft  
A me n d me nt 5  
 
6 2  
C o nfi de ntial a n d Pr o prietar y  
Pr ot oc ol secti o n  
Re m o ve d te xt i n stri ket hr o u g h a n d ne w te xt i n b ol d 
Iss ue/r ati o n ale f or c h a n ge 
Secti o n  9. 2. 6. 3   
I n acc or da nce wit h c urre nt xe n otra ns pla ntati o n pr o d uct g ui deli nes, a n arc hi val 
sa m ple will be c ollecte d at Baseli ne pri or t o Strata Graft place me nt. A s m all 
a m o u nt of bl o o d ( 3 m L) will be c oll ecte d bef ore Str at a Gr aft a p plic ati o n. 
T his s a m ple c o ul d be use d as a b aseli ne t o assess he alt h iss ues t h at m a y be 
rel ate d t o tre at me nt. T hese s a m ples will be use d o nl y f or t he p ur p ose of 
res p o n di n g t o a re q uest fr o m F D A. B ot h arc hi v al s a m ples a n d a n y 
ass oc i ate d s u bject i nf or m ati o n will be st ore d a n d use d o nl y as re q uire d a n d 
all o we d b y l a w. F or f urt her details, see t he ce ntral la b orat or y ma n ual . 
Clarif yi n g t he st ora ge d urati o n 
a n d use of c ollecte d arc hi val 
sa m ples. 
Secti o n  9. 6   
Healt h Ec o n o mics Researc h C are Res o urce  Utilizati o n ( H C R U) 
U p dati n g Secti o n title wit h 
c orrect n o me nclat ure  
 
 
 

Si g nat ure Pa ge f or V V- C LI N- 0 3 0 6 6 8 v 2. 0
Si g nat ure Pa ge f or V V- C LI N- 0 3 0 6 6 8 v 2. 0
A p pr o val Tas k
2 8- Se p- 2 0 2 3 1 8: 5 8: 0 1 G M T + 0 0 0 0