Status:
WITHDRAWN
Allogeneic Skin Grafting
Lead Sponsor:
University of Minnesota
Conditions:
GVHD
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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 don...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04015947
Start Date
August 1 2019
End Date
April 1 2021
Last Update
April 20 2021
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55414