Using patients' own skin cells to create thicker skin for better wound healing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the feasibility of transforming normal skin into thicker skin similar to that found on the palms and soles. Investigators will extract autologous skin fibroblasts from a participant's palm or sole, multiply these cells in a laboratory, and then inject them into a different skin area, such as the buttock. The goal is to assess whether these grafts can induce a change in skin properties, potentially improving skin resilience for individuals with amputations and prosthetics. This innovative approach could provide new solutions for managing skin breakdown in vulnerable areas.

Why it matters

Who can join: the full rules

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

Where it's running

• Johns Hopkins School of Medicine, Dermatology Department
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Luis Garza, MD, PhD — Department of Dermatology, Johns Hopkins School of Medicine
• Study coordinator: Ruizhi Wang
• Email: rwang53@jhmi.edu
• Phone: 410-502-7546

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.