The study will enroll 20 adults ages 18-75 with a transtibial amputation with mature residual limbs who are ambulatory prosthesis users. Participants will be randomized to either treatment with low dose volar fibroblast injections (n=10) or to vehicle control (n=10). Participants will undergo a biopsy to harvest volar skin for fibroblast expansion and tattooing to identify injection sites on the residual limb. 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 randomized to the treatment group will be treated with low-dose cells. Injections will be administered on at least 1 and up to three separate days over the course of one week. 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 skin firmness and thickness, skin appearance, and patient-reported outcomes. After the final monitoring visit, individuals randomized to the vehicle 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) Patients treated with volar fibroblast injections will have firmer skin on the residual limb compared with patients tread with vehicle alone.
Ages 18 to 75, inclusive
Must have a transtibial amputation
Must be using a prosthesis within the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month
In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained up to 14 days before baseline for which the investigator identified no clinically significant abnormality.
A skin erosion deeper than the skin dermis.
Ulcers exceeding 4cm in diameter or 2cm in radius
Non circular ulcers that cannot tolerate a 1cm margin at all sides
Having received any investigational drug within 30 days prior to study entry
Crossover
Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees
Combination productAutologous Volar Fibroblasts Treatment- harvested from patient's biopsied volar skin. Intradermal injection of Volar fibroblasts in the residual limb of transtibial amputees.
Safety assessment of complications and adverse events associated with Volar Fibroblast injections
Safety will be evaluated by routinely assessing all complications at each study visit. Minor and expected complications may include local injection reactions like bruising and erythema, swelling and pain. Minor complications that are not expected include local small hemorrhage (x\<1mL), edema, nodules, papules, irritation, dermatitis, pruritus, and cellulitis. Serious Adverse Events are defined as unexpected AND serious AND related or possibly related to the study treatment. These may include but are not limited to osteomyelitis.
Efficacy of autologous volar fibroblasts for increasing skin firmness in individuals with a transtibial amputation.
Efficacy will be determined by treatment group difference in the pre- post-change in skin firmness at three months post injection. Skin firmness is the level of resistance as measured by a non-invasive hand-held durometer
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Major Extremity Trauma Research Consortium
Lead sponsor
United States Department of Defense
Collaborator
