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RecruitingAccepts healthy volunteersPhase 2

Feasibility Study for Fibroblast Autologous Skin Grafts

Johns Hopkins University · with National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NCT01964859

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
80
US sites recruiting
1
Study start
January 7, 2015
Record last updated
June 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: autologous skin fibroblasts; Filler Product

Conditions: Wounds and Injuries

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Johns Hopkins School of Medicine, Dermatology Department

    Baltimore, MD 21287

    Site contact: Sherry Leung · 410-502-7546 · ctrep@jhmi.edu

Study contacts (from the official record)

  • Ruizhi Wang · 410-502-7546 · rwang53@jhmi.edu
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Feasibility Study for Fibroblast Autologous Skin Grafts (NCT01964859) | Bored Studies