NCT01964859

Feasibility Study for Fibroblast Autologous Skin Grafts

Feasibility Study for Fibroblast Autologous Skin Grafts: Biopsy of Skin Fibroblasts, Expansion in Cell Therapy Core, Topical Injection of Fibroblasts, and Subsequent Removal of Graft for Laboratory Studies.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This research is being done to determine if investigators can change skin from one type to another. Specifically, investigators are interested in making normal skin into the thicker skin found on our palms and soles.

Detailed description

To change the skin identity investigators propose to take skin cells from a person's own sole or palm (these are called "autologous skin fibroblasts"), multiply them in the lab, inject the cells (now called a "graft") back into the same person but at a different site of skin like the buttock, and then eventually remove the injected cells to see if they caused the skin to change. Investigators hope that information from this study will help with problems like skin break-down in patients with amputations and prosthetics. The skin at their stump was not meant to withstand the pressure and friction of prosthetics and this study is the first step in trying to convert stump skin to palm/sole-like skin. In some select subjects the investigators will test if the addition of an FDA approved filler product might enhance cellular efficacy.

Conditions

• Wounds and Injuries

Interventions

Type	Name	Description
BIOLOGICAL	autologous skin fibroblasts	autologous skin fibroblasts
BIOLOGICAL	Filler Product	In some select subjects the investigators will test if the addition of an FDA approved filler product Bellafill might enhance cellular efficacy.

Timeline

• Start date: 2015-01-07
• Primary completion: 2027-12-02
• Completion: 2028-11-01
• First posted: 2013-10-17
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States