Scientists test injecting skin cells to create tougher skin
NCT ID NCT01964859
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study explores whether injecting special skin cells (fibroblasts) can change normal skin into the thicker skin found on palms and soles. Researchers will take a small skin sample, grow the cells in a lab, and inject them back into the skin. They will measure changes in cell size and firmness. The goal is to learn if this approach could help heal wounds or improve skin quality.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous skin fibroblasts (with or without Bellafill filler)
- What this could lead to
- If successful, this could point toward a way to grow thicker, tougher skin for wound healing or skin repair.
- What could go wrong
- This is an early feasibility study with only 80 participants. It focuses on lab measurements, not clinical outcomes, so real-world benefits are uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2015
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Wounds and injuries are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Johns Hopkins School of Medicine, Dermatology Department
RECRUITINGBaltimore, Maryland, 21287, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Spinal fluid antibody shots tested for fresh spinal cord injuries
- A new physical therapy twist could rebuild knees after dislocation
- Can whole blood beat component transfusions in trauma?
- Testosterone may rebuild strength after spinal cord injury — trial puts it to the test
- Which humidifier prevents airway blockages in trauma ICU patients?
- Penis transplants could restore form and function for wounded warriors