Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 1 of 20 7/15/2010 9:57 AM

MEDICAL 

RESEARCH

AND 

TECHNOLOGY

MEDICAL 

ADVANCED 

DEVELOPMENT

DEPLOYMENT

FDA 

Approval
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 2 of 20 7/15/2010 9:57 AM

Environmental Hazards

 Heat and Cold

 Altitude

 Toxic Industrial 

Chemicals & Materials

Systems Hazards

 Laser

 Blast

 Biomechanical 

Insults and Stresses

 Noise

Operational Stressors

 Sleep Deprivation 

 Traumatic Stress and 

Situational Stressors

 Physical Work Load

 Cognitive Burden & 

Operational Complexity

Endemic Disease Threats

 Parasitic Diseases

 Bacterial Diseases

 Viral Diseases

Chemical/Biological 

Warfare Threats

 Bacterial Threats

 Viral Threats

 Toxin Threats

 Nerve Agents

 Vesicant Agents

 Blood Agents

Combat Injuries

 Hemorrhage

 Head Trauma

 Blast Injury

Difficulties of Medical 

Command, Control, 

Communications, Computer, 

Intelligence, Surveillance and 

Reconnaissance (C4ISR)
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 3 of 20 7/15/2010 9:57 AM

Working Together

Joint programs

Service collaboration

Contemporary Health Threats

Blast Injury 

Post Traumatic Stress Disorder (PTSD)

Traumatic Brain Injury (TBI)

Restoration and 

rehabilitation of 

Wounded Warriors

Help Reset the Force

Revolutionary Approaches

Improved laboratory techniques 

(high performance computing, etc.)

Systems biology

Collaborative 

interdisciplinary 

research teams
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 4 of 20 7/15/2010 9:57 AM

(1) Basic Research, (2) Applied Research, and (3) Advanced Technology Development to prove techbase concepts for medical products (drugs, biologics & devices) and information

CHEMICAL & BIOLOGICAL DEFENSE 

PARTNERSHIP SUPPORT 

DIRECTORATE (PSD)

LTC Nick Koterski

Interface with Defense Threat 

Reduction Agency (DTRA)

• Medical Biological Defense 

Research Program (MBDRP)

Managed by DTRA

► Vaccines and pre-treatments

► Small molecule therapies

► Next generation diagnostics

► Animal model development

► Broad-spectrum therapeutics

• Medical Chemical Defense Research 

Program (MCCDRP)

Managed by DTRA

► Nerve agent pre-treatments

► Therapeutics for nerve agents

► Therapeutics for vesicant injury

► Diagnostic assays/technologies

BLAST INJURY COORDINATING 

OFFICE – Mr. Mike Leggeri

• History: 

► Directed by Congress in FY06 National 

Defense Authorization Act

► Established by DoD Directive 6025.21E

► Secretary of the Army is Executive Agent

► USAMRMC is program coordinator

• Mission: 

Coordinate DoD medical research programs 

focused on the prevention, mitigation, and 

treatment of blast injuries.

• Key Accomplishments:

► ID knowledge gaps to focus blast injury 

research programs across DoD, federal 

agencies, academia, and industry

► Developed funding requirements

► Established the Joint Trauma Analysis and 

Prevention of Injury in Combat (JTAPIC) 

Program - provides a coordinated approach 

to improve tactics, techniques, procedures, & 

materiel solutions to prevent blast injuries

► Strengthened collaboration between medical 

researchers and materiel developers to 

provide improved individual and combat 

vehicle blast protection systems

Before

Right middle finger during an 

early stage of regrowth after 

an August 2005 accident cut 

off the tip.

After

After four months of healing.

Product: Extract of pig bladder for 

promoting healing and tissue 

regeneration.

PI: Dr. Stephen Badylak, University of 

Pittsburgh

Example of Tissue Regeneration

ARMED FORCES INSTITUTE OF 

REGENERATIVE MEDICINE (AFIRM) 

COL Bob Vandre

• A virtual organization of 27 universities and 230 

scientists working with the US Army Institute of 

Surgical Research under a five-year 

cooperative agreement 

• Expected to make major advances in the ability 

to understand and control the cellular response 

in wound repair and organ/tissue regeneration 

as well as designing and engineering new 

biomaterial scaffolds to guide the regeneration 

process

• Expected that this institute will be able to 

translate some of its technologies into patients 

within the five-year period

Research Funds from DoD Research Funds from Many Sources Research Funds from Army, Navy, Air Force, NIH, and VA
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 5 of 20 7/15/2010 9:57 AM

Discover, develop, and translate regenerative medicine 

technologies having both near term and far-term translation 

potential

To provide cutting-edge medical capabilities to heal and reset 

our warriors who have catastrophic traumatic injuries and 

disabilities

4. Compartment 5. Burn Repair

Syndrome

2. Healing Without 

Scarring

1. Cranio-Facial 

Reconstruction

3. Limb and Digit 

Salvage and 

Reconstruction
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 6 of 20 7/15/2010 9:57 AM

Cell-based therapy

Cell Bioactives -Scaffold Hybrid

Scaffold

All major scientific 

approaches to 

tissue 

regeneration are 

utilized in the 

development of 

regenerative 

therapies for the 

wounded service 

member
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 7 of 20 7/15/2010 9:57 AM

Nerve, Bone, Other Connective and Soft Tissue
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 8 of 20 7/15/2010 9:57 AM

Goal: Because severely burned patients need skin and need it fast, 

development based on ink jet printer technology device to “print” skin 

directly on burns is underway.

The system will include a scanner to determine the size and depth of the 

burn.

PI: James Yoo
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 9 of 20 7/15/2010 9:57 AM

Goal: Injectable and/or implantable soft tissue substitute resulting in sustained shape 

and volume over time to provide precise shape of facial features after craniofacial 

injury.

Based upon biomaterial scaffolds comprised of silk, collagen, and hyaluronic acids, 

along with autologous cellular elements. 

First clinical trial will be an initial study on the use of autologous adipose derived stem 

cells in a lipoaspirate scaffold. During the coming year, we will determine the optimal 

combination of biomaterials for the clinical therapy

PI: Peter Rubin

Athymic mice sacrificed 6 weeks after injection with lipoaspirate mixed with GFP labeled ASCs (n=6). 

Tissues formed subcutaneously were exposed, excised and measured with water displacement method. 

A. lipoaspirates mixed with 2x106 ASCs. B. lipoaspirates alone C. Tissues harvested after 6 weeks. Left: 

lipoaspirates with ASCs, Right: lipoaspirate without ASCs
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 10 of 20 7/15/2010 9:57 AM

1. Hand transplants (accelerated with Congressional Special Interest funding)

2. Face transplants

3. Use of porcine extracellular matrix to regenerate limb muscle form and function (accelerated with 

JIEDDO/OTT funding)

4. Engineered Skin Substitute (ESS) to treat >50% TBSA burns 

5. Autologous skin cell spraying to treat burn injuries with less scarring (ReCell®)

6. Autologous fat injections to reduce severity of burn scarring (AFT)

7. Skin graft stretching to reduce degree of scarring

8. Segmental nerve gap regeneration using a novel nerve scaffold biomaterial (2010 new start)

9. Safety and efficacy of allogeneic skin substitute for burn coverage (2010 new start)

10. Bandage for Improved healing and scar reduction (2010 new start)

OTT* contributions (2010 new starts) to AFIRM investigators

 Autologous skin cell spraying to repair excessive scars

 Nanoscale Ca PO4 scaffolds for craniomaxillofacial repairs

 Allogeneic Cultured Human Dermal Fibroblasts injections to remodel facial scars

BTI**

 Autologous Adipose Derived Stem Cells For Soft Tissue Reconstruction After Facial Trauma

Moving quickly on our strategy to translate regenerative medicine technologies to 

the clinic

*Office of Technology Transition

** Biotechnology Initiative
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 11 of 20 7/15/2010 9:57 AM

Goal: Protocol for treatment of 

forearm or hand loss by 

transplantation with local 

immunomodulation

Status: Enrollment at approved 

sites is currently underway

PI- Andy Lee, U. Pitt
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 12 of 20 7/15/2010 9:57 AM

CT scan showing 10% increase 

in quadriceps mass (red circled 

area) at 4 months post surgery.

Novel application of 

extracellular matrix to 

encourage regeneration of 

large muscle

PI: S. Badylak, U. Pitt
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide Page 13 of 20 13/ 7/15/2010 9:57 AM

• A regenerative device that uses 

patient’s own cells to treat 

burns, wounds and chronic skin 

defects.

• Goal: FDA approval & the first 

Class I efficacy data w/ longterm outcome data

PI- J. Holmes, 

Wake Forest and Avita Medical

Avita Medical has received approval from the FDA to 

begin its US clinical trial for ReCell spray-on skin. The 

company claims it to be the first regenerative device 

enabling surgeons to treat burns, wounds and chronic 

skin defects using the patient’s own cells (December 

2009 Press Release)

Courtesy Avita Medical 
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 14 of 20 7/15/2010 9:57 AM

A small sample of a patient’s skin is digested and seeded onto a 

resorbable matrix, then treated to grow into a full thickness sheet of 

engineered skin.

PI: S. Boyce, Cincinnati Children’s Hospital
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 15 of 20 7/15/2010 9:57 AM

PI: Sang-jin Lee

Goal: in vitro tissue expander system that permits a rapid increase in surface 

dimensions of donor skin while maintaining tissue viability for subsequent skin 

transplantation. This system was successfully tested and validated on human 

skin samples.

Consistently able to double the surface area of donor skin within 2 weeks while 

maintaining cell viability and showed viable graft take, in animals, when 

implanted on a recipient dermal bed. 

Completed design and built a clinically applicable bioreactor system. 

Defined clinical trial strategy. 
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 16 of 20 7/15/2010 9:57 AM

50.52

18.64

0.00

10.00

20.00

30.00

40.00

50.00

60.00

VAS - Control VAS - Treated

Average VAS score

32 point 

decrease 

(p=0.0039)

PI- G. Gurtner, Stanford Univ 

Preliminary Pilot trial in humans 

post-abdominal surgery (n=9) 

show safety and dramatic 

efficacy of stress-shielding 

device
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 17 of 20 7/15/2010 9:57 AM

EVIDENCE

OPINION

GOOD IDEAS RECEPTOR 

SITES

EVALUATION & 

RESEARCH

POLICY & 

DECISIONS

• New Idea Website1

• Standing BAA 

(Broad Agency 

Announcement)2

• Special CSI 

Solicitations3,4

• HQ Program Staff

• Other Command 

Personnel

USAMRMC

INPUT

• Private Industry

• Academia

• Entrepreneurs

• Innovations

• “Salesmen”

• Congress

• DOD/Services

• Military Leaders

• Soldiers

• Families

• Others

FIELDED MEDICAL POLICIES, 

INFORMATION, AND PRODUCTS

• DOD

• MHS

• Army

• OTSG

• MEDCOM

• Defense 

Centers of 

Excellence

• Services

FEEDBACK

KNOWLEDGE GAP BRIDGING REQUEST

• Program Reviews

• Peer Review

• Knowledge of Other 

Service and Agency 

Programs

• Intramural 

Research Programs

• Extramural 

Research Programs

CONSENSUS
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 18 of 20 7/15/2010 9:57 AM

√ Clinical and Rehabilitative Medicine Research Programhttps://crmrp.amedd.army.mil/

√ AFIRM - http://www.afirm.mil/

√ Grants announcements- http://grants.gov

√ Broad Agency Announcementshttp://www.usamraa.army.mil/pages/baa_forms/User/login.cfm

√ SBIR/STTR- http://www.acq.osd.mil/osbp/sbir/solicitations/

√ Federal contract solicitations- https://www.fbo.gov/

√ Ideas-http://www.usamraa.army.mil/pages/products_ideas/user/login.cfm

√ CDMRP- http://cdmrp.army.mil/

√ TATRC- http://www.tatrc.org/
Dr. James Stewart (301-619-9810)/ james.stewart@us.army.mil UNCLASSIFIED Slide 19 of 20 7/15/2010 9:57 AM