Feasibility Study for Fibroblast Autologous Skin Grafts

This study is exploring if we can change skin from one type to another, specifically making normal skin thicker like the skin on your palms and soles. Researchers will take skin cells from your own sole or palm (called "autologous skin fibroblasts"), grow them in a lab, and then inject them into a different skin area, like your buttock. In some cases, an FDA-approved filler product called Bellafill might also be used to see if it helps. The main goal is to see if the injected cells cause the skin to change, measured by an increase in cytoplasmic size at 6 months. This study is for adults aged 18 to 65 years who are medically able to participate. The current recruitment status is unclear.

Study design: This is an interventional study with a planned enrollment of 80 participants. It is not specified if the study is randomized or blinded.
What's involved: You would undergo laboratory tests, have skin cells taken from your sole or palm, and receive injections of these cells into a different skin site. The injected cells would eventually be removed to check for skin changes.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint, cytoplasmic size increase, is measured at 6 months after the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Feasibility Study for Fibroblast Autologous Skin Grafts

Recruiting

PHASE2Ages 18–65InterventionalBasic science

Johns Hopkins University

~80 participants

Updated 2026-06-09 on ClinicalTrials.gov

What's tested:autologous skin fibroblastsFiller Product

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Cytoplasmic size increase

Measured over 6 months

Conditions

Wounds and Injuries

NCT01964859

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Johns Hopkins School of Medicine, Dermatology Department
Baltimore, Marylandstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Luis Garza, MD, PhD · PRINCIPAL_INVESTIGATOR · Department of Dermatology, Johns Hopkins School of Medicine

Who to contact

Ruizhi Wang

[email protected]

410-502-7546

Email the study team

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Eligibility criteria

Inclusion

May be male or female

Must be between 18 years and 65 years of age

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 abnormality.

Be able to comprehend the informed consent document and provide consent for participation

Females of childbearing potential must:

have a negative pregnancy test at screening

agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study

be willing to use a reliable form of contraception during the study

Have healthy skin as determined by the PI or study Nurse Practitioner.

Be willing and able to comply with the scheduled visits, biopsy/injection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.

Exclusion

Having received any investigational drug within 30 days prior to study entry

An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, or hetastarch

Pregnant, lactating, or trying to become pregnant

A history of keloid formation

An active nonhealing wound

Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, Human T-lymphotropic virus (HTLV) I/II, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate.

Specifically we will exclude those with autoimmune diseases affecting the skin such as lupus.

Having current skin diseases (i.e. extreme and active eczema, psoriasis, lichen planus) that the investigator feels is not safe for study participation

A diagnosis of uncontrolled diabetes

Active smoker during the study

We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.

Known bovine or meat sensitivity or severe allergies manifested by anaphylaxis to any product

Known bleeding disorder

What this trial measures

Cytoplasmic size increase6 months
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.

Trialytics