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Cell Therapy

Fibroblast Injection for Amputation Healing

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 have a below the knee amputation

Must be between 18 years and 65 years of age

Must not have

Presence of necrotic ischemic tissue on any stump ulcers, and/or capillary refill on stump skin of greater than 3 seconds

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial is testing whether injecting skin cells from the palm or sole can thicken the skin layer at the site of an amputation below the knee, in order to improve healing.

Who is the study for?

This trial is for adults aged 18-65 with below-knee amputations who use a prosthetic. Women must not be pregnant, breastfeeding, or planning to become pregnant and agree to contraception. Excluded are those with deep skin erosions, certain medical conditions (like autoimmune diseases), allergies to study materials, active infections, recent neuromas, or on immunosuppressives.

What is being tested?

The trial tests autologous volar fibroblast injections versus placebo in thickening the stump's skin layer for amputees. Participants will receive either their own cultured skin cells or a placebo injected into the stump site at Johns Hopkins.

What are the potential side effects?

Potential side effects may include local reactions at the injection site such as pain, redness, swelling; risk of infection; allergic reactions to components used during treatment; and possible systemic responses like fever.

Eligibility Criteria

Inclusion Criteria

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

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I have had an amputation below the knee.

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I am between 18 and 65 years old.

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I am of childbearing age and my pregnancy test was negative.

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I agree not to become pregnant or breastfeed during and for 1 month after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have dead tissue on my amputation site or slow blood return in the skin.

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I am not on long-term immunosuppressive treatments, including oral or topical steroids.

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I have a skin wound that is deeper than the outer layer of my skin.

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I have a known bleeding disorder.

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I have a history of severe allergies, like anaphylaxis.

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I have an infection in the part of my body where a limb was amputated.

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I have been using a prosthetic for less than 3 months.

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I have a history of blood disorders or take medications that can affect my blood.

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I do not have an autoimmune disease like lupus affecting my skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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

Safety as assessed by number of hospitalizations

Secondary study objectives

Change in amount of skin breakdown as assessed by ulceration measurement

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Autologous skin fibroblastsExperimental Treatment1 Intervention

For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives autologous skin fibroblast whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives autologous skin fibroblasts.

Group II: ControlPlacebo Group1 Intervention

For whole stump participants: The investigators will be comparing whole stump injection sites that receive autologous skin fibroblasts to vehicle (placebo) injections. This subject receives vehicle (placebo) whole stump injections. For localized injection participants: The investigators are comparing two injection sites in the same individual. This site receives a placebo.

0 / 13Eligibility criteria met