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Feasibility Study for Fibroblast Autologous Skin Grafts

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ClinicalTrials.gov Identifier: NCT01964859
Recruitment Status : Recruiting
First Posted : October 17, 2013
Last Update Posted : May 29, 2019
Sponsor:
Collaborators:
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 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 2020
Estimated Study Completion Date : December 2022

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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 2 weeks 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, antibiotics, antimycotics, dimethyl sulfoxide, human albumin, or bovine constituents, or hetastarch
  • Specifically: subjects allergic to penicillin, streptomycin, amphotericin will be excluded in addition to those listed above.
  • 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, 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

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 ClinicalTrials.gov identifier (NCT number): NCT01964859


Contacts
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Contact: Ruizhi Wang 410-502-7546 rwang53@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins School of Medicine, Dermatology Department Recruiting
Baltimore, Maryland, United States, 21287
Contact: Sherry Leung    410-502-7546    ctrep@jhmi.edu   
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
Investigators
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Principal Investigator: Luis Garza, MD, PhD Department of Dermatology, Johns Hopkins School of Medicine

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov 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 29, 2019
Last Verified: May 2019
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
prosthetics
amputations
dermal fibroblasts
Additional relevant MeSH terms:
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Wounds and Injuries