Safety and Efficacy Study of hAESCs Therapy for aGVHD
Status:
Not yet recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT), a process in which
hematopoietic stem cells from a donor are injected into the recipient's body, are the
treatment of choice for many hematologic malignancies. Graft-versus-host disease (GVHD) is a
common and important complication after allogeneic HSCT. GVHD is a major obstacle to the
success of HSCT treatment and a leading cause of death after HSCT treatment.
Hormone therapy is currently the standard treatment for aGVHD, i.e., the first-line
treatment. However, 40%~50% of aGVHD cannot be controlled by hormone therapy, and additional
therapeutic intervention is required. According to the National Comprehensive Cancer Network
(NCCN) clinical practice guidelines for hematopoietic stem cell transplantation -
pre-transplant recipient evaluation and management of GVHD (2021.V3), the recommended drugs
for second-line treatment of grade II~IV aGVHD include: alemtuzumab, α-1 antitrypsin,
antithymocyte globulin, basiliximab, calcineurin inhibitors, etanercept, extracorporeal
photopheresis replacement therapy, infliximab, mammalian rapamycin target protein inhibitors,
mycophenolate mofetil, Pentostatin, ruxolitinib, tocilizumab. Second-line treatment is based
on retrospective data and there is no standard salvage therapy, which is reflected in the
inconsistent treatment strategy for aGVHD across transplant centers.
One of the biological functions of hAESCs in amniotic membranes in vivo is to exert
reproductive immunomodulatory effects and protect the fetus from rejection by the maternal
immune system, so hAESCs have natural immunomodulatory functions. hAESCs have significant
inhibitory effects on T cells, antigen-presenting cells (APCs), natural killer (NK) cells,
macrophages, neutrophils, B cells and other immune cells associated with organ damage during
the pathogenesis of aGVHD, and hAESCs have great potential in the treatment of aGVHD.
Therefore, the sponsor developed hAESCs injections intended for the treatment of aGVHD.
The experimental drug in this study is hAESCs injection, which is intended to be used for the
treatment of adult patients with grade III.~IV. refractory aGVHD after hematopoietic stem
cell transplantation, and to explore the safety and preliminary efficacy of its treatment.
Phase:
Phase 1
Details
Lead Sponsor:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China