Using patients' own skin cells to create thicker skin for better wound healing
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.
This study is testing if using a patient's own skin cells to make thicker skin can help improve healing and protect areas of the body that are at risk of breakdown, especially for those with amputations and prosthetics.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT01964859 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with no significant skin abnormalities.
Not a fit: Patients with existing skin conditions or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance skin durability for patients with amputations, reducing complications and improving quality of life.
How similar studies have performed: While the approach of using autologous skin cells is promising, this specific application is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.