Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650553
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
Umbilical Cord Blood-Supported Haplo-HSCT for Aplastic Anemia Treatment Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on Umbilical Cord Blood-Supported Haploidentical Hematopoietic Stem Cell Transplantation for the Treatment of Aplastic Anemia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aplastic anemia AA is a rare bone marrow failure syndrome with an annual incidence of about 074100000 affecting all ages but more common in the elderly Its divided into congenital and acquired forms with the latter being more prevalent The primary acquired form is linked to T lymphocyte activation and genetic factors The best treatment is allogeneic hematopoietic stem cell transplantation allo-HSCT with a near 90 cure rate Sibling allo-HSCT is ideal but finding a match is challenging For those who relapse after immunosuppressive therapy haploidentical HSCT is a viable option despite risks like graft failure and GVHD Advances in transplantation have made haplo-HSCTs efficacy comparable to other methods Recent studies suggest co-transplantation with umbilical cord blood cells can improve outcomes by hastening hematopoietic recovery and prognosis Our study will evaluate the feasibility and safety of this approach in AA treatment comparing it to sibling fully matched transplantation with a focus on infection rates GVHD incidence TRM and EFS aiming to enhance treatment practices and benefit patients and the medical industry
Detailed Description:
Aplastic anemia aplastic anaemiaAA is a syndrome of bone marrow hematopoietic dysfunction bone marrow hematopoietic failureBMFwith an annual incidence rate of approximately 074100000 people affecting all age groups with a higher incidence rate in the elderly and similar incidence rates between males and females AA is divided into congenital and acquired types with acquired AA being more common The pathogenesis of primary acquired AA is mainly related to the abnormal activation of T lymphocytes and genetic background may also play a role in the development and progression of AA Currently allogeneic hematopoietic stem cell transplantation allo-HSCT is the best treatment for AA with a cure rate close to 90 Sibling allogeneic hematopoietic stem cell transplantation HLA-matched HSCT is the preferred treatment plan but it is not easy to find a fully matched sibling donor For patients who relapse after immunosuppressive therapy IST haploidentical hematopoietic stem cell transplantation haplo-HSCT is a good alternative despite the risks of engraftment failure infection and graft-versus-host disease GVHD With the advancement of transplantation technology the efficacy of haplo-HSCT is not significantly different from that of unrelated donor hematopoietic stem cell transplantation MUD-HSCT and HLA-matched sibling donor hematopoietic stem cell transplantation MSD-HSCT Studies have shown that haplo-HSCT has a higher survival rate in treating patients with severe aplastic anemia SAA and there is no significant difference compared to MSD-HSCTTo address the risk of complications associated with haplo-HSCT recent research has indicated that co-transplantation with third-party umbilical cord blood cells can shorten the time for hematopoietic reconstitution and improve prognosis The co-transplantation of third-party umbilical cord blood with bone marrow and peripheral blood hematopoietic stem cells has become a new transplantation option Studies at home and abroad have shown that combined third-party transplantation can shorten the time for hematopoietic reconstitution and improve long-term survival rates This study plans to adopt a prospective open-label parallel-controlled trial design to conduct a clinical study of non-related umbilical cord blood-assisted haploidentical allogeneic hematopoietic stem cell transplantation for the treatment of AA The study will compare the umbilical cord blood combined with haploidentical transplantation plan with sibling fully matched transplantation to assess the feasibility and safety of the umbilical cord blood combined with haploidentical transplantation plan and to monitor the incidence of patient infections acutechronic GVHD incidence transplant-related mortality TRM and event-free survival EFS in the hope of providing new practical experience in the field of AA treatment and bringing dual benefits to patients and the social medical enterprise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None