RecruitingPhase 2NCT01964859

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.


Sponsor

Johns Hopkins University

Enrollment

80 participants

Start Date

Jan 7, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests autologous fibroblast therapy — using a patient's own skin cells to create a personalized skin graft treatment. Small biopsies of healthy skin are taken, fibroblast cells are grown in the lab, and then injected back into the patient's skin to test safety and feasibility of this regenerative approach. You may be eligible if... - You are between 18 and 65 years old - You have healthy skin as assessed by the study team - You are in good overall health with no significant laboratory abnormalities - If female and of childbearing potential, you agree to use contraception and avoid pregnancy during the study You may NOT be eligible if... - You have received an investigational drug in the past 30 days - You have an allergy to local anesthetic, DMSO, human albumin, bovine products, or hetastarch - You are pregnant, lactating, or trying to become pregnant - You have a history of keloid formation - You have an active non-healing wound - You have HIV, hepatitis B or C, HTLV I/II, autoimmune skin diseases, active skin conditions, or uncontrolled diabetes - You are an active smoker or on chronic immunosuppressive medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALautologous skin fibroblasts

autologous skin fibroblasts

BIOLOGICALFiller Product

In some select subjects the investigators will test if the addition of an FDA approved filler product Bellafill might enhance cellular efficacy.


Locations(1)

Johns Hopkins School of Medicine, Dermatology Department

Baltimore, Maryland, United States

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NCT01964859


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