Allogeneic Skin Grafting

GVHD Clinical Trial

Official title:

Allogeneic Skin Grafting in the Treatment of Chronic Cutaneous Graft-versus-host Disease: a Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04015947
• Other study ID #: DERM-2016-25255
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• GVHD

Intervention

Device:
• CelluTome® Epidermal Harvesting System
split-thickness skin grafts from a matched bone marrow donor using the CelluTome® Epidermal Harvesting System

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CGAA	Evaluation of clinical improvement in inflammation and sclerosis based on visual inspection and photodocumentation with outcome outcomes determined using the Chronic GVHD Activity Assessment (CGAA) to measure therapeutic response. The CGAA is an 8-item assessment measuring symptom severity of GVHD on a scale from 0 (not present) to 10 (as bad as you can imagine). Global score is calculated by summing items.	Change from baseline up to 12 months
Primary	Change in ELISA Markers of GVHD	Chronic GVHD lesions will be assessed following transplantation through serum ELISA assays of elafin and CXCL10 (validated biomarkers for assessment of GVHD disease activity)	Change from baseline up to 12 months