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Cell Therapy

Autologous Skin Grafts for Wounds and Injuries

Phase 2

Recruiting

Led By Luis Garza, MD, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be between 18 years and 65 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing whether investigators can change the type of skin on a person's body.

Who is the study for?

Adults aged 18-65 with healthy skin who can follow the study's procedures, including visits and wound care. Women must test negative for pregnancy, not plan to become pregnant or breastfeed during the study, and use contraception. Excluded are those with allergies to study materials, certain medical conditions like autoimmune diseases or uncontrolled diabetes, active smokers, or on chronic immunosuppressive therapies.Check my eligibility

What is being tested?

The trial is testing if it's possible to transform normal skin into thicker palm/sole-type skin using autologous (patient's own) skin fibroblasts. Participants will undergo a procedure where these cells are injected into their normal skin.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site such as pain, redness or swelling; allergic reactions to components of the treatment; and possibly keloid formation (thick scarring).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cytoplasmic size increase

Secondary outcome measures

Durometer reading

Trial Design

1Treatment groups

Experimental Treatment

Group I: autologous skin fibroblastsExperimental Treatment1 Intervention

we are comparing 3 injection sites in the same individual

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,262 Previous Clinical Trials

14,823,084 Total Patients Enrolled

28 Trials studying Wounds and Injuries

16,260 Patients Enrolled for Wounds and Injuries

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,492,419 Total Patients Enrolled

33 Trials studying Wounds and Injuries

11,859 Patients Enrolled for Wounds and Injuries

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

484 Previous Clinical Trials

1,086,927 Total Patients Enrolled

8 Trials studying Wounds and Injuries

5,787 Patients Enrolled for Wounds and Injuries

Media Library

Wounds and Injuries Clinical Trial 2023: Autologous Skin Fibroblasts Highlights & Side Effects. Trial Name: NCT01964859 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment accept participants under the age of fifty?

"This clinical trial is available to patients between the age of 18 and 65. Additionally, there are 122 separate trials for minors and 589 studies designed for seniors."

Answered by AI

What is the current enrollment rate for this clinical trial?

"Affirmative. Clinicaltrials.gov has information that this research is actively accepting participants, having been published on July 1st 2015 and recently updated on August 6th 2022. This medical trial requires 80 patients from one site to participate in the study."

Answered by AI

Are there any eligibility requirements I must meet to be included in this experiment?

"This medical trial will investigate the efficacy of a new wound care treatment and is open to 80 participants aged 18-65 who possess an existing injury. In order for applicants to be eligible, they must agree to comply with all study procedures, consent to a negative pregnancy test at screening, abstain from conceiving or breastfeeding during/after the study period, have healthy skin as determined by the principal investigator (PI) or Nurse Practitioner (NP), and not exceed 65 years old."

Answered by AI

Does this research endeavor still accept new participants?

"Affirmative. According to public information from clinicaltrials.gov, this research endeavour is still open for recruitment and began enrollment on July 1st 2015. The study seeks 80 patients at a single medical location with the last update being recorded in June 2022."

Answered by AI

Is the usage of autologous skin fibroblasts sanctioned by the FDA?

"Considering the Phase 2 status of this medication, our team at Power has assigned a score of two to autologous skin fibroblasts in terms of safety. This indicates that there is some available data verifying its security, though none proving its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility Study for Fibroblast Autologous Skin Grafts

2015. "Feasibility Study for Fibroblast Autologous Skin Grafts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01964859.

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