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Cell Therapy

Autologous Skin Grafts for Wounds and Injuries

Baltimore, MD
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
Must not have
An active nonhealing wound
A diagnosis of uncontrolled diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

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

See full description
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
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I am between 18 and 65 years old.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a wound that is not healing.
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My diabetes is not under control.
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I am not on long-term immunosuppressive drugs, including oral or topical steroids.
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I have a known bleeding disorder.
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I do not have autoimmune diseases like lupus affecting my skin.
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Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cytoplasmic size increase
Secondary study objectives
Durometer reading

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: autologous skin fibroblastsExperimental Treatment1 Intervention
we are comparing 3 injection sites in the same individual

Find a Location

Closest Location:Johns Hopkins School of Medicine, Dermatology Department· Baltimore, MD

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,361 Previous Clinical Trials
15,160,402 Total Patients Enrolled
28 Trials studying Wounds and Injuries
16,218 Patients Enrolled for Wounds and Injuries
National Institutes of Health (NIH)NIH
2,890 Previous Clinical Trials
8,050,620 Total Patients Enrolled
39 Trials studying Wounds and Injuries
13,881 Patients Enrolled for Wounds and Injuries
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
507 Previous Clinical Trials
1,089,706 Total Patients Enrolled
9 Trials studying Wounds and Injuries
5,881 Patients Enrolled for Wounds and Injuries
United States Department of DefenseFED
934 Previous Clinical Trials
338,120 Total Patients Enrolled
104 Trials studying Wounds and Injuries
36,423 Patients Enrolled for Wounds and Injuries
Luis Garza, MD, PhDPrincipal InvestigatorDepartment of Dermatology, Johns Hopkins School of Medicine

Media Library

Wounds and Injuries Clinical Trial 2023: Autologous Skin Fibroblasts Highlights & Side Effects. Trial Name: NCT01964859 — Phase 2
~17 spots leftby Dec 2027
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