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Autologous Skin Fibroblasts · 2 trials · 4 indications
To determine the safety of the use of autologous volar fibroblasts to reprogram non-volar to volar-like epidermis with larger cytoplasmic area in human participants. The investigators will measure the numbers of hospitalizations which are related to the study. The occurrence of any study related hospitalization will be counted as one.
Volar keratinocytes have larger area of the cytoplasm. We will quantitate the area of cytoplasm of non-volar keratinocytes to see if they increase selectively with volar fibroblasts as opposed to other fibroblasts injections or vehicle. The change in the area of cytoplasm of non-volar keratinocytes will be measured. The units of this measurement are a ratio of cytoplasmic area to total cellular area as a control.
| Arm | Type | Description |
|---|---|---|
| Autologous skin fibroblasts | EXPERIMENTAL | For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives autologous skin fibroblast whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives autologous skin fibroblasts. |
| Control | PLACEBO_COMPARATOR | For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives vehicle (placebo) whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives a placebo. |
| Name | Type | Description |
|---|---|---|
| Autologous Skin Fibroblasts | BIOLOGICAL | The site or whole stump will be injected with autologous fibroblasts |
| Placebo | BIOLOGICAL | The site or whole stump will be injected medium only without autologous skin fibroblasts |
| Filler Product | BIOLOGICAL | In some select subjects the investigators will test if the addition of an FDA approved filler product Bellafill might enhance cellular efficacy. |
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 os...
Autologous Skin Fibroblasts is an investigational cell therapy being studied for wounds and injuries, including skin wounds and amputation-related conditions. It is in Phase 2 clinical development for these dermatology indications. The therapy uses a patient's own fibroblasts, which are cells that help build connective tissue, to potentially aid in wound healing and tissue repair.
Autologous Skin Fibroblasts is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate this investigational therapy for wound healing and amputation-related conditions.
Autologous Skin Fibroblasts is currently in Phase 2 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The ongoing Phase 2 trials are recruiting participants to evaluate the therapy's safety and effectiveness for wounds and injuries, including amputation-related conditions.
Autologous Skin Fibroblasts is being studied in two Phase 2 clinical trials. NCT01964859, titled 'Feasibility Study for Fibroblast Autologous Skin Grafts,' is recruiting 80 participants with wounds and injuries in the United States. NCT03947450, titled 'Autologous Volar Fibroblast Injection Into the Stump Site of Amputees,' is recruiting 50 participants with amputation-related conditions. Both trials are randomized, double-blind, and placebo-controlled.
Autologous Skin Fibroblasts is a cell therapy that uses fibroblasts derived from the patient's own skin. Fibroblasts are cells that produce collagen and other components of the extracellular matrix, which are essential for wound healing and tissue repair. By injecting or grafting these cells into the affected area, the therapy aims to promote healing of wounds and injuries.