Feasibility Study for Fibroblast Autologous Skin Grafts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01964859
Recruitment Status : Recruiting
First Posted : October 17, 2013
Last Update Posted : May 23, 2018
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
United States Department of Defense
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Wounds and Injuries Biological: autologous skin fibroblasts Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Sites are labeled as A, B and C and masked for outcomes assessors-- but these are all in the same subject.
Primary Purpose: Basic Science
Official Title: 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.
Study Start Date : December 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: autologous skin fibroblasts
we are comparing 3 injection sites in the same individual
Biological: autologous skin fibroblasts

Primary Outcome Measures :
  1. Cytoplasmic size increase [ Time Frame: 6 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.

Secondary Outcome Measures :
  1. Fibrometer reading [ Time Frame: 6 months ]
    Fibrometers measure the firmness of the skin. We will measure all sites to see if the area injected with volar fibroblasts is more firm. The units of measurement is in Newtons.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • may be male or female
  • must be between 18 years and 65 years of age
  • must be medically able to undergo the administration of study material determined by laboratory tests obtained 2 weeks before baseline for which the investigator identified no significant abnormality
  • provide informed consent for participation
  • females of childbearing potential must: have a negative pregnancy test at screening, agree not be become pregnant or breastfeed for the period of the study, be willing to use reliable form of contraception during the study
  • be willing to comply with the scheduled visits, biopsy/injection procedures, wound care instructions, and treatment plan.

Exclusion Criteria:

  • received any investigational drug within 30 days prior to study entry
  • an allergy history to any study materials including anesthetic, antibiotics, antimycotics, dimethyl sulfoxide, human albumin, bovine constituents, hetastarch, penicillin, streptomycin, amphotericin
  • pregnant, lactating, or trying to become pregnant
  • history of keloid formation
  • an active wound
  • significant medical history of infectious disease (HIV, Human T- Lymphotrophic virus (HTLV) I/II, hepatitis B, hepatitis C), autoimmune conditions, cancer
  • current skin disease (eczema, psoriasis, lichen planus)
  • diagnosis of uncontrolled diabetes
  • active smoker
  • use of chronic immunosuppressive therapies such as oral and topical steroids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01964859

Contact: Sabrina Alessi 410-502-7546

United States, Maryland
Johns Hopkins School of Medicine, Dermatology Department Recruiting
Baltimore, Maryland, United States, 21287
Contact: Sherry Leung    410-502-7546   
Principal Investigator: Luis Garza, MD, PhD         
Sponsors and Collaborators
Johns Hopkins University
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
United States Department of Defense
Principal Investigator: Luis Garza, MD, PhD Department of Dermatology, Johns Hopkins School of Medicine

Responsible Party: Johns Hopkins University Identifier: NCT01964859     History of Changes
Other Study ID Numbers: NA_00068684
1R01AR064297-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Per the requirements of the journal in which we finally publish.

Keywords provided by Johns Hopkins University:
healthy skin
wounds and injuries
dermal fibroblasts

Additional relevant MeSH terms:
Wounds and Injuries