Allogeneic Skin Grafting

University of Minnesota (UMN)

Status: Withdrawn

Conditions: GVHD

Treatments: Device: CelluTome® Epidermal Harvesting System

Study type: Interventional

Funder types: Other

Identifiers

NCT04015947

DERM-2016-25255

Details and patient eligibility

About

The primary study objective is to evaluate local response to split-thickness skin grafts from a matched bone marrow donor to chronic GVHD-affected skin in a hematopoietic stem cell transplant patient.

Full description

While the mechanisms are still under active study, GVHD is thought to be a donor T-cell mediated attack that preferentially targets three organs: skin, intestine, and liver. T lymphocytes from the donor identify the patient's organ tissues as foreign and initiate inflammation, leading to end organ damage. The investigator's traditional approach has been to use immune suppressing drugs to dampen this inflammatory response after transplantation. However, this approach is ultimately ineffective for a significant percentage of patients. Therefore, the primary objective of this proposal is to test a novel non-immunosuppressive approach to treatment of cutaneous GVHD using allogeneic skin grafting in an effort to tolerize the engrafted immune system to skin it previously recognized as foreign. The potential benefit to transplant patients is tremendous, including reduced immunosuppression, improved quality of life and lower mortality.

A potential novel approach is to apply split-thickness skin grafts from the bone marrow donor to the affected patient's skin. There are four existing case reports that have shown positive outcomes in wound healing in chronic GVHD-associated ulcers. In all four cases, skin grafts were harvested from the patient's allogeneic HLA-matched sibling donors and placed over non-healing wounds (2-5). One case described global improvement in affected skin distant from the site of skin graft application, allowing for tapering of immunosuppressive medications. This suggests potential induction of tolerance by immune cells within the donated skin.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - Patient (Recipient)

• Subjects will be eligible to participate in the study if all of the following conditions exist:
• Diagnosis of chronic, sclerotic, cutaneous graft versus host disease with one or more areas of cutaneous sclerosis and
• More than 1 year after HCT with stable hematopoietic engraftment and original transplant donor is available and agrees to be the epidermal donor for this study
• Stable (mixed or full) donor hematopoietic engraftment
• Original transplant donor is available and willing to be the epidermis donor
• Site for skin grafting free of cellulitis or other evidence of infection
• Insurance pre-authorization for procedure
• Voluntary written consent prior to any research related procedures or treatment.

Inclusion Criteria - Donor

• Age > 18 years (based on prior safety testing of the device)
• Healthy on physical examination in the opinion of the evaluating physician
• Known negativity for Hepatitis B and C, HIV, and HTLV1/2
• Voluntary written consent prior to any research related procedures

Exclusion Criteria

Subjects will be excluded from participation in the study if any of the following conditions exist:

• Patient with cutaneous infection
• Patient with recent change in medical management of chronic cutaneous GVHD (new medication or therapy, or change in dosing of existing medication) within one month of start date.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Active treatment

Experimental group

Description:

This is an open label, single-institution pilot study to evaluate local response to split-thickness skin grafts from a matched bone marrow donor to chronic GVHD-affected skin in a hematopoietic stem cell transplant patient.

Treatment:

Device: CelluTome® Epidermal Harvesting System