natgillin/translations-raw huggingface dataset:
Even if the surgeon has already taken a small sample of cartilage cells (a biopsy) needed to produce the product, it is possible that you will not be eligible for treatment with ChondroCelect.
Čak i ako je kirurg postupkom biopsije već uzeo mali dio uzorka stanica hrskavice koje su potrebne za izradu lijeka, može se dogoditi da nećete biti podobni za liječenje lijekom ChondroCelect.
Treatment failure in the ChondroCelect group was generally related to delamination of the graft.
Neuspjeh liječenja u skupini liječenoj lijekom ChondroCelectbio je uglavnom povezan sdelaminacijom presatka.
In this technique, a good fixation using stitches on the edges of the collagen membrane is required, in order to assure a direct contact of the implanted cells with the defect bed.
U ovoj je tehnici potrebna dobra fiksacija, korištenjem šavova na rubovima kolagenske membrane, kako bi se osigurao izravan kontakt implantiranih stanica s ležištem na dnu hrskavičnog defekta.
Elderly population The use of ChondroCelect has not been studied in this age group.
Starije osobe Primjena lijeka ChondroCelect nije ispitana u ovoj dobnoj skupini.
From a pre-clinical study in the orthotopic goat model it appeared that this technique provided comparable results as the Brittberg technique, on condition that a good fixation is established using stitches on the edges of the collagen membrane.
činilo se da ova tehnika daje rezultate slične kao i Brittberg tehnika, pod uvjetom da je uspostavljena dobra fiksacija korištenjem šavova na rubovima kolagenske membrane.
Where possible, concomitant knee problems should be corrected prior to or at the latest at the time of ChondroCelect implantation.
Kada je god to moguće, prateći problemi s koljenom trebali bi se izliječiti prije ili najkasnije prilikom implantacije lijeka ChondroCelect.
The safe use of ChondroCelect has not been demonstrated during pregnancy or breast-feeding.
Nije dokazana sigurna upotreba lijeka ChondroCelect tijekom trudnoće ili dojenja.
Romeinse straat 12/2 3001 LEUVEN Belgium
Romeinse straat 12/2 3001 LEUVEN Belgija
ChondroCelect is therefore not recommended for use in children and adolescents below 18 years.
ChondroCelect se stoga ne preporučuje kod djece i adolescenata mlađih od 18 godina.
The safe use of ChondroCelect with other medicines has not been studied.
Nije provedeno ispitivanje sigurne upotrebe lijeka ChondroCelect s drugim lijekovima.
ChondroCelect must be administered by an appropriately qualified surgeon and is restricted to hospital use only.
ChondroCelect mora primjenjivati primjereno kvalificirani kirurg, a primjena je ograničena na bolničku primjenu.
• The handling of ChondroCelect and its preparation for the implantation
• Rukovanje lijekom ChondroCelect i njegovim pripravcima za implantaciju
Dulbecco's Modified Eagles Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Dulbecco's Modified Eagles Medium, DMEM) (kojai sadrži aminokiseline, vitamine, soli i ugljikohidrate).
What you need to know before you use ChondroCelect
Što morate znati prije primjene lijeka ChondroCelect
Seven patients treated with ChondroCelect needed re-intervention, compared to 10 patients in the microfracture group.
U sedam bolesnika liječenih lijekom ChondroCelect bio je neophodan ponovni zahvat, u usporedbi s 10 bolesnika u skupini liječenoj mikrofrakturom.
To keep the cartilage cells in place, a biological membrane is sewn over the defect.
Kako bi se stanice hrskavice održale na mjestu, preko oštećenja se prišiva biološka membrana.
ChondroCelect is not recommended for pregnant and breast-feeding women.
ChondroCelect se ne preporučuje trudnicama i dojiljama.
• The femoral condyle is the end of the thigh bone, which forms part of your knee.
• Femoralni kondil je završetak natkoljenične kosti koji čini dio Vašeg koljena.
If the surgeon decides that treatment with ChondroCelect is appropriate for you, he/she will take a small sample of cartilage cells (a biopsy) from your knee.
Ako kirurg odluči da Vam odgovara liječenje lijekom ChondroCelect, on/ona će postupkom biopsije uzeti mali uzorak stanica hrskavice iz
BATCH NUMBER, DONATION AND PRODUCT CODES Lot {lot number}
BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA Serija {broj serije}
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
• Uoči svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik.
Each vial contains 0.4 ml of autologous human cartilage cells suspension and is closed with a chlorobutyl stopper and aluminium seal.
Svaka bočica sadrži 0,4 ml suspenzije autolognih stanica hrskavice ljudskog podrijetla i zatvorena je čepom od klorobutila i aluminijskim prstenom.
The product is made from a small sample of cartilage cells (a biopsy) taken from your knee.
Lijek je dobiven iz malog uzorka stanica hrskavice koje su postupkom biopsije uzete iz Vašeg koljena.
Too early and vigorous activity may compromise the grafting and the durability of clinical benefit from ChondroCelect.
Prerana i preintenzivna aktivnost može ugroziti primanje presatka i trajnost kliničke koristi lijeka ChondroCelect.
≥1/1,000 to <1/100
Manje često ≥1/1000 i <1/100
Histological examination of the repair biopsy at 12 months showed superior structural repair in the ChondroCelect arm compared to the microfracture arm.
Histološko ispitivanje materijala biopsije s mjesta liječenja nakon 12 mjeseci pokazalo je bolji strukturalni oporavak kod skupine ispitanika liječenih lijekom ChondroCelect u usporedbi sa skupinom ispitanika liječenom mikrofrakturom.
Patients with acute or recent history of bone or joint infections should be temporary deferred until documented recovery.
Liječenje bolesnika s akutnom ili nedavnom infekcijom kostiju ili zglobova treba se privremeno odgoditi sve do potvrđenog ozdravljenja.
For information on preparation and handling of ChondroCelect, please refer to section 6.6.
Za informacije o pripremi i rukovanju lijekom ChondroCelect, vidjeti dio 6.6. 4.3 Kontraindikacije
ChondroCelect can only be prescribed and implanted by an orthopaedic surgeon in a hospital.
Kako primjenjivati ChondroCelect ChondroCelect može propisati i implantirati samo kirurg − ortoped u bolnici.
Driving cars and using machines may be limited during the rehabilitation period.
Tijekom rehabilitacije možda će postojati ograničenja za upravljanje vozilima i rad sa strojevima.
The vials are placed in a sterile falcon tube with a plastic screw top.
Bočice se nalaze u sterilnoj falcon epruveti s plastičnim navojnim vrhom.
There was continuous improvement up to 36 months in the clinical outcome measure KOOS (the Knee Injury and Osteoarthritis Outcome Score) in both treatment arms.
36 mjeseci u mjeri kliničkog ishoda KOOS (rezultat mjerenja ishoda nakon oštećenja koljena i osteoartritisa; engl. the Knee Injury and Osteoarthritis Outcome Score) u obje liječene skupine.
These studies have demonstrated that this type of fibrin sealant can be safely used with ChondroCelect.
Ova su ispitivanja pokazala da se ta vrsta sredstva za zatvaranje na bazi fibrina može sigurno upotrebljavati u kombinaciji s lijekom ChondroCelect.
- ChondroCelect should be implanted in an otherwise healthy knee.
- ChondroCelect treba se implantirati u koljeno koje je po svim ostalim kriterijima zdravo.
In clinical studies with ChondroCelect a periosteal flap was used as a biological membrane.
Tijekom kliničkih ispitivanja provedenih s lijekom ChondroCelect kao biološka membrana koristio se periostalni režanj.
Upon implantation, the patient should follow an appropriate rehabilitation schedule and physical activity should be resumed as recommended by the physician.
Nakon implantacije bolesnik mora slijediti odgovarajući plan rehabilitacije te plan tjelesne aktivnosti prema preporuci liječnika.
A technical variant of the ACI procedure is the cell seeding method, whereby the cells are seeded onto a collagen membrane prior to implantation.
Tehnička varijanta ACI postupka je metoda nacjepljivanja stanica, pri čemu se stanice nacjepljuju na kolagensku membranu prije implantacije.
Do not use ChondroCelect if you: are allergic to any of the ingredients of ChondroCelect (listed in section 6) or to bovine serum suffer from advanced osteoarthritis (degenerative joint disease) in your knee.
Nemojte primjenjivati ChondroCelect - Ako ste alergični na bilo koji sastojak lijeka ChondroCelect (naveden u dijelu 6) ili na goveđi serum
ChondroCelect was compared to the procedure of microfracture in the repair of symptomatic single cartilage lesions of the femoral condyles of the knee.
ChondroCelect je uspoređen s postupkom mikrofrakture prilikom popravka pojedinačnih simptomatskih lezija hrskavice femoralnog kondila koljena.
Too early and vigorous activity may compromise the implant and the durability of clinical benefit from ChondroCelect.
Prerana i preintenzivna aktivnost može ugroziti implantat i trajnost kliničke koristi lijeka ChondroCelect.
No statistically significant difference could be observed in clinical benefit between ChondroCelect and microfracture at that point in time.
U tom trenutku, nisu opažene statistički značajne razlike u kliničkoj koristi između skupine liječene lijekom ChondroCelect i skupine liječene mikrofrakturom.
How to store ChondroCelect
Kako čuvati ChondroCelect
During open-knee surgery, the cartilage cells are implanted into the cartilage defect.
Tijekom operacije na otvorenom koljenu, stanice hrskavice se implantiraju u oštećenje hrskavice.
- If you have any further questions, ask your doctor, surgeon or physical therapist.
- Ako imate dodatnih pitanja, obratite se svom liječniku, kirurgu ili fizioterapeutu.
The training material for other healthcare professionals shall include the following key messages and components:
• Protokol praćenja Materijal za obuku ostalih zdravstvenih djelatnika treba uključivati sljedeće ključne poruke i dijelove:
Overall, the clinically relevant benefit of ChondroCelect implantation observed over baseline after 36 months was maintained up to 60 months after treatment.
Sveukupno, klinički značajna korist implantacije lijeka ChondroCelect opažena nakon 36 mjeseci u odnosu na osnovicu održana je i
ChondroCelect consists of autologous cultured cartilage cells.
ChondroCelect se sastoji od autolognih stanica hrskavice uzgojenih u kulturi.
Before re-suspension the cells are settled to the bottom of the container forming an off-white layer and the excipient is a clear colourless liquid.
Prije resuspenzije stanice se nalaze na dnu spremnika i tvore bjelkasti sloj, a pomoćna tvar je prozirna bezbojna tekućina.
OTHER SPECIAL WARNING(S), IF NECESSARY For autologous use only.
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Lijek smije upotrijebiti samo bolesnik kojemu je propisan.
Arthrofibrosis
• artrofibroza
In these patients, a periosteal flap was used to secure the implant.
U tih se bolesnika za učvršćivanje implantata koristio periostalni režanj.
After the 5 year follow-up period, 37 patients were evaluated in the ChondroCelect arm and 40 in the microfracture arm.
Nakon 5-godišnjeg razdoblja praćenja, procijenjeno je 37 bolesnika u skupini liječenoj lijekom ChondroCelect i 40 bolesnika u skupini podvrgnutoj mikrofrakturi.
Do not use this medicine after the expiry date which is stated on the container and vial after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na spremniku i bočici nakon oznake „Rok valjanosti“.
• Obligation to conduct post-authorisation measures Not applicable.
• Obaveza provođenja mjera nakon davanja odobrenja
Before administration, ChondroCelect should be resuspended by gently tapping the vial to bring the cells back into suspension.
Prije primjene lijek ChondroCelect treba resuspendirati laganim lupkanjem bočice kako bi se stanice vratile nazad u suspenziju.
Children and adolescents The use of ChondroCelect is not recommended in children and adolescents below 18 years.
Primjena lijeka ChondroCelect se ne preporučuje u djece i adolescenata mlađih od 18 godina.
Adverse reactions occurred in 78.4% of the patients over a 36-months postoperative follow-up period..
Tijekom postoperativnog razdoblja praćenja od 36 mjeseci nuspojave su se pojavile u 78,4%
NAME OF THE MEDICINAL PRODUCT ChondroCelect 10,000 cells/microlitre implantation suspension
NAZIV LIJEKA ChondroCelect 10 000 stanica/mikrolitar suspenzija implantata
adverse reactions are presented in order of decreasing seriousness.
nuspojave su poredane prema padajućem redoslijedu ozbiljnosti.
Most of the reported adverse reactions were expected as related to the open-knee surgical procedure..
Većina prijavljenih nuspojava očekivani je rezultat kirurškog postupka na otvorenom koljenu..
This cartilage sample will be used to make ChondroCelect.
Uzorak hrskavice upotrijebit će se za izradu lijeka ChondroCelect.
The MAH shall perform the pharmacovigilance activities as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates.
Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
When a collagen membrane was used to seal the lesion site after application of ChondroCelect, the incidence of cartilage hypertrophy was reported to be 1.8% compared to 25% in the randomized, controlled trial alone.
primijećena incidencija hipertrofije hrskavice bila je 1,8% u usporedbi s 25% u samom randomiziranom kontroliranom ispitivanju.
ChondroCelect is solely intended for autologous use and should be administered in conjunction with debridement (preparation of the defect bed), a physical seal of the lesion (placement of a biological membrane, preferentially a collagen membrane) and rehabilitation.
Lijek ChondroCelect namijenjen je isključivo za autolognu primjenu i treba se primjenjivati u kombinaciji s debridmanom (kirurškim odstranjivanjem mrtvog tkiva), fizičkim zatvaranjem lezije (postavljenjem biološke, po mogućnosti kolagenske membrane) i rehabilitacijom.
Cases in which ChondroCelect cannot be supplied
Slučajevi u kojima se lijek ChondroCelect ne može dostaviti
What ChondroCelect contains - The active substance of ChondroCelect consists of a treatment dose of viable autologous human cartilage cells in vials containing 4 million cells in 0.4 ml, corresponding to a concentration of
Sadržaj pakiranja i druge informacije Što ChondroCelect sadrži - Djelatna tvar lijeka ChondroCelect sastoji se od doze za liječenje vijabilnim autolognim stanicama hrskavice ljudskog podrijetla u bočicama koje sadrže 4 milijuna stanica u 0,4 ml, što odgovara koncentraciji od 10 000 stanica po mikrolitru.
• Informed consent for the patients to be signed prior to the treatment with ChondroCelect
• Informirani pristanak za sve bolesnike koji oni trebaju potpisati prije liječenja lijekom
If you have any further questions on the use of this medicine, ask your doctor or physical therapist.
U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili fizioterapeutu.
ChondroCelect is intended solely for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI).
ChondroCelect je namijenjen isključivo za autologno liječenje hrskavice i primjenjuje se u bolesnika postupkom implantacije autolognih hondrocita (eng.
Wound infection, Erysipelas, Erythema,
Poremećaji kože i potkožnog tkiva infekcija rane, erizipel (crveni vjetar), eritem,
It will take at least four weeks to select and culture the cells to make ChondroCelect.
Selekcija i uzgoj stanica za izradu lijeka ChondroCelect trajat će najmanje četiri tjedna.
Visit 2: ChondroCelect implantation
2. posjet: implantacija lijeka ChondroCelect
This is called ‘autologous chondrocyte implantation' (ACI).
Autologous Chondrocyte Implantation, ACI).
- ChondroCelect is not recommended for the repair of cartilage defects in other locations than the femoral condyle.
ChondroCelect se ne preporučuje za popravak oštećenja hrskavice na mjestima koja nisu femoralni kondil.
Other cases in which ChondroCelect cannot be supplied
Ostali slučajevi u kojima se lijek ChondroCelect ne može dostaviti
Fibrin glues are routinely used in ACI procedures to seal the outside margins and to improve the water-tightness of the compartment of the biological membrane used to cover the defect.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Fibrinska ljepila rutinski se upotrebljavaju u ACI postupcima za zatvaranje vanjskih rubova i za poboljšavanje vodonepropusnosti odjeljka biološke membrane koja se koristi za prekrivanje oštećenja.
Keep the product vial(s) within the falcon tube in the outer plastic screw top container in order to protect from light and bacterial/fungal contamination.
Bočicu(e) lijeka čuvajte u falcon epruveti u vanjskom spremniku s plastičnim navojnim vrhom kako biste ju zaštitili od svjetla i bakterijske/gljivične kontaminacije.
MINIMUM PARTICULARS TO APPEAR ON SMALL INTERMEDIATE PACKAGING UNITS
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
NAME OF THE MEDICINAL PRODUCT ChondroCelect
NAZIV LIJEKA ChondroCelect
This is the case if the biopsy is of insufficient quality to make ChondroCelect, or in some instances, it may be the cells cannot be grown in the laboratory or that the cells after expansion do not meet all the quality requirements Your surgeon will be informed and might have to select an alternative treatment for you.
ChondroCelect ili, u nekim slučajevima, može se dogoditi da se stanice ne mogu uzgojiti u laboratoriju ili da stanice nakon umnažanja ne ispunjavaju sve uvjete kvalitete.
ChondroCelect 10,000 cells/microlitre implantation suspension.
ChondroCelect10 000 stanica/mikrolitar suspenzija implantata.
Chondromalacia, Gonarthrosis
tendonitis hondromalacija, gonartroza
Related to ChondroCelect:
Povezano s lijekom ChondroCelect:
• The implantation procedure by knee-joint arthrotomy
• Postupak implantacije putem artrotomije zgloba koljena
Implantation of ChondroCelect is to be performed during arthrotomy under sterile conditions and requires both preparation of the defect bed and a seal (biological membrane) to secure the implant.
Implantacija lijeka ChondroCelect treba se obaviti tijekom artrotomije u sterilnim uvjetima, a za zaštitu implantata potrebna je priprema ležišta na dnu hrskavičnog defekta i zatvaranje lezije
EXPIRY DATE EXP {DD month YYYY} at {hours} CET SPECIAL STORAGE CONDITIONS Store between 15°C - 25°C.
POSEBNE MJERE ČUVANJA Čuvati na temperaturi između 15°C - 25°C.
ChondroCelect is used to repair single symptomatic cartilage defects in the femoral condyle of the knee in adults.
ChondroCelect se koristi za popravak pojedinačnog simptomatičnog oštećenja hrskavice femoralnog kondila koljena odrasle osobe.
• The handling of the biopsy harvest
• Postupak uzimanja tkiva za biopsiju
Common side effects ( affects in 1 to 10 users in 100) include: restriction of knee motion (arthrofibrosis, decreased joint range of motion, decreased mobility), excessive amount of joint fluid in the joint (joint effusion), joint lock, joint inflammation (arthritis, bursitis, synovitis), cavity filled with fluid in the knee (bone cyst, synovial cyst), bone swelling, cartilage disorder (chondropathy), benign bony growth (exostosis), blood in a joint (haemarthrosis), joint instability, joint stiffness, loose body in joint, weakening of muscle (muscle atrophy, Trendelenburg's sign), degenerative joint disorder (osteoarthritis), tendon disorder, inflammation of the tendon (tendonitis), impaired healing, treatment failure, gait disturbance, implant site hypersensitivity, peripheral edema, fever (pyrexia), postoperative wound complication (wound site reaction) ,wound infection (including erysipelas), redness, scar overgrowth, itching, scar pain, wound loosening, wound secretion loosening of the graft or membrane (graft complication, graft delamination), injury (cartilage injury, joint injury), blood clot in the deep vein of the leg (deep vein thrombosis), large bruise (haematoma), superficial vein inflammation (phlebitis), nausea, pain or nerve disorder (pain in extremity, peripheral neuropathy, complex regional pain syndrome, autonomic neuropathy), syncope, apnea, arthroscopy.
(tendonitis), slabo zarastanje, neuspjeh liječenja, poremećaj hoda, preosjetljivost na mjestu implantacije, periferni edem, vrućica (pireksija), komplikacija rane nakon operacije (reakcija na mjestu rane), infekcija rane (uključujući erizipel), crvenilo, prekomjeran rast ožiljka, svrbež, bol ožiljka, razdvajanje rane, iscjedak iz rane, opuštanje presatka ili membrane (komplikacije s presatkom, delaminacija presatka), ozljeda (ozljeda hrskavice, ozljeda zgloba), krvni ugrušak u dubokoj nožnoj veni (duboka venska tromboza), velika modrica (hematom), površinska upala vena (flebitis), mučnina, bol ili poremećaj živaca (bol u udovima, periferna neuropatija, kompleksni regionalni bolni sindrom, autonomna neuropatija), sinkopa, apneja, artroskopija.
Dispose of in accordance with local requirements.
OD LIJEKA, AKO JE POTREBNO Odlagati u skladu s važećim lokalnim propisima.
- have a growth plate of the knee that is not fully closed
Ako imate nepotpuno zatvorenu ploču rasta koljena
- The other ingredient is sterile, buffered Dulbecco's Modified Eagles Medium (DMEM), a liquid containing amino acids, vitamins, salts and carbohydrates to store the cells in the vial.
Modified Eagles Medium, DMEM), tekućina koja sadrži aminokiseline, vitamine, soli i ugljikohidrate za pohranu stanica u bočici.
There are no data on the use of ChondroCelect during breast-feeding.
Nema podataka o primjeni ChondroCelecta za vrijeme dojenja.
Depending on the location, the size of the lesion and the patient's profile, appropriate rehabilitation instructions have been developed.
Odgovarajuće upute za rehabilitaciju razvijene su ovisno o položaju, veličini lezije i profilu bolesnika.
Graft complication, Graft delamination, Cartilage injury, Injury,
postoperativna komplikacija rane, svrbež, bol ožiljka, dehiscencija rane, iscjedak iz rane
Most side effects of ChondroCelect implantation are side effects related to open-knee surgery.
Većina nuspojava vezana uz implantaciju lijeka ChondroCelect odnosi se na operaciju na otvorenom koljenu.
EXP {DD month YYYY} at {hours} CET
ROK VALJANOSTI Rok valjanosti {DD mjesec GGGG} u {sati} po srednjeeuropskom vremenu
Autonomic neuropathy, Complex regional pain syndrome,
Poremećaji živčanog sustava autonomna neuropatija, kompleksni regionalni bolni sindrom, bol u udovima, periferna neuropatija, sinkopa,
Therefore, based upon the safety profile of ChondroCelect, which requires the submission of 1yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years' time.
a, CHMP zaključuje da nositelj odobrenja mora, nakon 5 godina, podnijeti zahtjev za još jednu obnovu.
Each vial of product contains 4 million autologous human cartilage cells in 0.4 ml cell suspension, corresponding to a concentration of 10,000 cells/microlitre.
TVARI Svaka bočica sadrži 4 milijuna autolognih stanica hrskavice ljudskog porijekla u 0,4 ml što odgovara koncentraciji od 10 000 stanica po mikrolitru.
The falcon tube is placed in a plastic screw top container together with surgery materials (one sterile syringe of 1 ml, one 18G intravenous catheter and two pieces of Vicryl 6.0) and a temperature monitor.
1 falcon epruveta s 1, 2 ili 3 bočice (x 0,4 ml) Bočice se isporučuju s kirurškim materijalom (jedna sterilna štrcaljka od 1 ml, jedan intravenski kateter 18G i dva komada pribora za šivanje Vicryl 6.0)
At this time point 41 patients were evaluated in the ChondroCelect arm and 49 were evaluated in the microfracture arm.
Do tada je ocijenjen 41 bolesnik u skupini ispitanika liječenih lijekom ChondroCelect i 49 u skupini ispitanika liječenih mikrofrakturom.