Feasibility Study for Fibroblast Autologous Skin Grafts

NCT01964859 | Recruiting Phase 2 DMC

• 2 other identifiers: NA_000686841R01AR064297-01A1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

healthy skin; wounds and injuries; prosthetics; amputations; dermal fibroblasts

Outcome Measures

Primary Outcomes (1)

• Cytoplasmic size increase

  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.

  6 months

Secondary Outcomes (1)

• Durometer reading

  6 months

Study Arms (1)

autologous skin fibroblasts

EXPERIMENTAL

The investigators are comparing 3 injection sites in the same individual

Biological: autologous skin fibroblasts; Biological: Filler Product

Interventions

autologous skin fibroblasts BIOLOGICAL

autologous skin fibroblasts

autologous skin fibroblasts

Filler Product BIOLOGICAL

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

Also known as: Bellafill

autologous skin fibroblasts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• United States Department of Defense: collaborator
• Maryland Stem Cell Research Fund: collaborator

Study Sites (1)

Johns Hopkins School of Medicine, Dermatology Department

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

ArteFill

Study Officials

• Luis Garza, MD, PhD

  Department of Dermatology, Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruizhi Wang

CONTACT

410-502-7546; rwang53@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Sites are labeled as A, B and C and masked for outcomes assessors-- but these are all in the same subject.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2013
• First Posted: October 17, 2013
• Study Start: January 7, 2015
• Primary Completion (Estimated): December 2, 2027
• Study Completion (Estimated): November 1, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)