What side effects are associated with this type of intervention?

Common treatments for Epidermolysis Bullosa (EB) include hematopoietic cell transplantation and intradermal allogenic fibroblast injections. Hematopoietic cell transplantation, particularly with myeloablative regimens, carries significant risks including high mortality rates and complications such as infections and graft-versus-host disease. Intradermal allogenic fibroblast injections have shown promise in promoting wound healing and collagen synthesis but may cause localized reactions at the injection site. Both treatments aim to improve skin integrity and reduce blistering, but their side effects necessitate careful consideration and monitoring.

What prior FDA approvals exist?

The FDA has approved various treatments for Epidermolysis Bullosa (EB), but specific approvals for therapies involving epidermal skin grafting with permissive immune system and skin chimerism are not detailed in the provided context. However, the CelluTome System, an FDA-approved vacuum device, is being studied for local wound therapy in EB patients, enabling scar-free harvesting of epidermis and its transfer to the recipient. This approach aligns with regenerative therapies aimed at long-term wound healing and epidermal engraftment.

What other types of research exist?

Promising novel alternatives to Epidermal Skin Grafting for Epidermolysis Bullosa patients include: 1) Allogeneic cord blood platelet gel, which has shown increased recovery rates and promotion of healing in dystrophic EB patients post-surgery. 2) Intradermal allogenic fibroblast injections, which have demonstrated increased collagen VII expression and improved wound healing. 3) Stem cell therapy, particularly using allogenic mesenchymal stem cells (MSCs), which have been shown to promote healing and reduce blister formation. 4) Bioengineered skin flaps with perfusable vascular pedicles, which have shown rapid neovascularization, tissue integration, and skin regeneration without scarring.

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Epidermal Harvesting System

Cellutome System for Epidermolysis Bullosa

N/A

Waitlist Available

Led By Christen Ebens, MD, MPH

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

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

Must have

Diagnosis of Dystrophic Epidermolysis Bullosa (DEB) or Junctional Epidermolysis Bullosa (JEB) with at least one wound, visibly free from infection (or previously treated) and meets the eligibility for Arm A or Arm B based on the skin graft source

Peripheral blood donor chimerism should be measured within 21 days of grafting and be >/= 5% and stable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after grafting

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help patients with hard-to-heal wounds by using skin grafts. The grafts are taken without leaving scars and placed on the wounds to promote healing. This method is an emerging option to improve wound healing.

Who is the study for?

This trial is for individuals with Epidermolysis Bullosa (EB) who have at least one wound suitable for treatment. Participants must be over 2 years old, off immune suppressive therapy, and have had a hematopoietic cell transplant from a donor or possess naturally gene-corrected skin. They should not have any infections or autoimmune issues pre-transplant and must consent to the procedure.

What is being tested?

The study tests the Cellutome Epidermal Harvesting System on EB patients. It involves taking epidermal grafts either from their previous bone marrow donor or their own mosaic skin and applying it to wounds using a special vacuum device in hopes of achieving long-term healing.

What are the potential side effects?

While specific side effects are not listed, potential risks may include discomfort during the harvesting process, infection at the graft site, rejection of the epidermal grafts, or complications related to wound healing.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have DEB or JEB with at least one wound that is not infected.

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My blood test shows at least 5% donor cells after a transplant, and it's stable.

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I have never had autoimmune blood disorders before a bone marrow transplant.

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I am not on any immune-suppressing medications.

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My condition involves a genetic change that reversed a previous mutation.

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My skin grafting area is healthy and free from infections or abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after grafting

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks after grafting

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after grafting for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Grafts Successfully Treated

Secondary study objectives

Longevity of Grafted Skin

Participants With Lesion Free Skin

Percentage Change of a Patient's IScorEB Assessment Score

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Self donor from intact skin patchExperimental Treatment1 Intervention

Cells are harvested from the subject using Cellutome, then transferred via Adaptic dressing to that subject's wound with up to 3 harvest sites/treated wound sites on day 0.

Group II: Graft from HCT donorExperimental Treatment1 Intervention

Cells are harvested from a donor using Cellutome, then transferred via Adaptic dressing to the recipient's wound with up to 3 donor harvest sites/treated wound sites on day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cellutome Epidermal Harvesting System

2016

N/A

~40

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Epidermolysis Bullosa (EB) include epidermal skin grafting and stem cell therapy. Epidermal skin grafting involves harvesting healthy skin, often from a donor or from the patient’s own mosaic skin, and transplanting it to wound sites. This method leverages the permissive immune system and skin chimerism to enable long-term engraftment and wound healing. Stem cell therapy, particularly using allogeneic bone marrow or mesenchymal stem cells, aims to reprogram cells to produce collagen type VII, essential for skin integrity. These treatments are crucial for EB patients as they address the root cause of skin fragility and promote durable wound healing, significantly improving quality of life.

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