GVHD Clinical Trial - Allogeneic Skin Grafting

Status Withdrawn

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

GVHD

Clinical Trial Details

NCT number	NCT04015947
Study type	Interventional
Source	University of Minnesota
Contact
Status	Withdrawn
Phase	N/A
Start date	August 1, 2019
Completion date	April 1, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02942173` - CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT	Phase 2/Phase 3
Terminated	`NCT01940796` - Phase I Trial of Brentuximab Vedotin for Refractory Chronic Graft-vs.-Host Disease (GVHD)	Phase 1
Completed	`NCT02066051` - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD	N/A
Not yet recruiting	`NCT05544448` - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases	N/A
Completed	`NCT01295710` - Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD)	Phase 3
Not yet recruiting	`NCT06000982` - Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis	Phase 3
Not yet recruiting	`NCT06075225` - MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib	Phase 2
Active, not recruiting	`NCT03680092` - Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation	Phase 2
Not yet recruiting	`NCT06083129` - Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor	Phase 3
Not yet recruiting	`NCT05094765` - Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD	Early Phase 1
Active, not recruiting	`NCT05415410` - Proof-of-concept Trial of Apraglutide in GVHD	Phase 2
Completed	`NCT02441075` - 70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014	N/A
Completed	`NCT02588339` - Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention	Phase 2
Not yet recruiting	`NCT06334367` - Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT	Phase 2
Completed	`NCT03846479` - Itacitinib for Low Risk GVHD	Phase 2
Completed	`NCT02891603` - A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression	Phase 1/Phase 2
Completed	`NCT02712762` - Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients
Completed	`NCT03945591` - High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)	Phase 2
Terminated	`NCT02338232` - Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation	N/A
Completed	`NCT02156479` - Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Allo-HSCT Recipients