Johns Hopkins University
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.
This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins. The investigators have demonstrated that injection of fibroblasts (from the palm or sole) is safe in healthy adults and potentially enhances palm or sole features in skin cells in areas other than the palm and sole. In a prior study, healthy adults injected with fibroblasts (from the palm or sole) experienced more…
Inclusion Criteria: Patients interested in study participation must meet all of the following inclusion criteria: * May be male or female * Must be between 18 years and 65 years of age * Must have a below the knee amputation. * Must be using a prosthetic for 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 within 7 days before baseline for which the investigator identified no clinically significant abn…
The site or whole stump will be injected with autologous fibroblasts
The site or whole stump will be injected medium only without autologous skin fibroblasts
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