Research Clinical Trials

AFIRM-Funded Clinical Trials - The AFIRM conducts clinical trials so that research can be translated from the laboratory to the clinic. For more information, click on the links below.

Current Clinical trials:

AFIRM II Clinical Trials

Extremity Injury Treatment

• ER-05: Phase 1/2 Prospective Double-blind, Placebo-controlled Randomized Clinical Trial Using Losartan to Treat Grade II and III Hamstring Strains

Facial/Skull Reconstruction

• CF-06: An Explorative Clinical Prospective Feasibility Study to Address the Effectiveness and Safety of Calciumphosphate/Poly(lactic-co-glycolic-acid) for Bone Augmentation in Maxillary Sinus Floor Elevation Surgery – conducted at Radboud University in the Netherlands
• CF-11: A Phase I Open-Label Study Evaluating the Safety of Acellular Adipose Tissue (AAT), a Novel Soft Tissue Reconstruction Solution, in Healthy Volunteers

Hand and Face Transplantation

• CTA-09: Vascularized Composite Allotransplantation of the Hand (HandCTA)
• CTA-10: Face Transplantation
• CTA-11: Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants

Skin Injury Treatment

• SR-06: StrataGraft^® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns – Completed Phase 1. Phase II trial pending.
• SR-08: Reducing Side Effects of Autologous Skin Tissue Harvesting – Massachusetts General Hospital
• ER-11: Feasibility Study for Fibroblast Autologous Skin Grafts – Johns Hopkins University

AFIRM I Trials

Limb and Digit Salvage

• WFPC 4.4.2: Human Upper Extremity Allotransplantation

Burn Repair

• RCCC 4.7.2: Safety and Efficacy Study of Autologous Engineered Skin Substitute to Treat Partial- and Full-Thickness Burn Wounds
• RCCC 4.2.7: ReCell^® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
• RCCC 4.2.7: StrataGraft^® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns – completed

Craniofacial Reconstruction

• RCCC 4.3.1b: Face Transplantation Clinical Trial (Cleveland Clinic)
• WFPC 4.1.4/4.1.5: A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury (BTI) – completed
• WFPC 4.1.4/4.1.5: Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort (BTI Plus Up) – completed
• WFPC 4.1.4/4.1.5: Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material (BTI++) – completed

Limb Reconstruction, regeneration or transplantation

• WFPC 4.1.4/4.1.5: Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection

Wound Healing without Scarring

• RCCC 4.7.3: Autologous Fat Transfer for Scar Prevention and Remodeling
• WFPC 4.5.9: A Study of a Novel Silicone Dressing to Minimize Scar Formation (REFINE) – completed
• WFPC 4.5.9: Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE) – completed

Several of these studies are still recruiting participants.