Feasibility Study for Fibroblast Autologous Skin Grafts

NCT ID: NCT01964859

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-07
• Study Completion Date: 2028-11-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

autologous skin fibroblasts

The investigators are comparing 3 injection sites in the same individual

Group Type: EXPERIMENTAL

autologous skin fibroblasts

Intervention Type: BIOLOGICAL

autologous skin fibroblasts

Filler Product

Intervention Type: BIOLOGICAL

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

Interventions

autologous skin fibroblasts

autologous skin fibroblasts

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Bellafill

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

Maryland Stem Cell Research Fund

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Garza, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology, Johns Hopkins School of Medicine

Locations

Johns Hopkins School of Medicine, Dermatology Department

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ruizhi Wang

Role: CONTACT

rwang53@jhmi.edu

410-502-7546

Facility Contacts

Sherry Leung

Role: primary

ctrep@jhmi.edu

410-502-7546

Other Identifiers

1R01AR064297-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00068684

Identifier Type: -

Identifier Source: org_study_id