Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.

A Phase 2 Multicenter Randomized Single Arm Crossover Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees

The study will enroll 38 adults ages 18-65 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users with active skin problems. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=19) or to a vehicle control (n=19). Participants will undergo biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the stump. Fibroblasts will be processed at the Hopkins Cellular Therapy Core Lab and volar cells primed for injection will be sent to participating centers for administration. Participants will be treated with low dose cells with Bellafill to enhance engraftment. Injections will be administered on at least 2 and up to three separate days over the course of one week. Injections will be administered to the affected area. Participants randomized to the vehicle control group will receive injection of cryoprotectant. All participants will be followed at 2 weeks, 1, 2 and 3 months after the last injection. These visits will include a clinical evaluation for complications, non-invasive assessments of wound size, skin firmness and thickness, wound recurrence and patient reported outcomes. After the final monitoring visit, individuals randomized to the control group will have the opportunity to receive the volar fibroblast injections and will be followed for an additional 3 months. The investigators hypothesize that (1) There will be no difference in the rate of serious adverse events among patients treated with volar fibroblast injections compared with patients treated with vehicle control, and (2) The rate of wound healing will be faster in patients treated with volar fibroblast injections compares with patients tread with vehicle control.

Multicenter Trial Evaluating the Safety and Efficacy of Autologous Volar Fibroblast Injection Into the Terminal Limb of Amputees.

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