Recruiting

Phase 2

Fibroblast GraftsFeasibility Study for Fibroblast Autologous Skin Grafts

Sponsor:

Johns Hopkins University

Code:

NCT01964859

Conditions

Wounds and Injuries

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

autologous skin fibroblasts

Filler Product

Study Details

Brief 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.

Conditions

Wounds and Injuries

Study ID

NCT01964859

Start date

Jan 7, 2015

Status verified date

Jun, 2026

Completion date

Nov 1, 2028

Anticipated

Primary completion date

Dec 2, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: autologous skin fibroblasts

The investigators are comparing 3 injection sites in the same individual

Interventions

autologous skin fibroblasts

Filler Product

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

Primary outcome measure

Cytoplasmic size increase [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Ruizhi Wang

410-502-7546 rwang53@jhmi.edu

Locations

Johns Hopkins School of Medicine, Dermatology Department

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Sherry Leung

410-502-7546 ctrep@jhmi.edu

Principal Investigator:

Luis Garza, MD, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

healthy skin
wounds and injuries
prosthetics
amputations
dermal fibroblasts

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-09.