Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06039436
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-09-09
Brief Title:
Conditioning Regimen Containing Low Dose ATG for The Treatment of Acquired SAA Receiving sUCBT
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
Conditioning Regimen Containing Low Dose ATG for The Treatment of Acquired Severe Aplastic Aplasia Receiving Single Cord Blood Transplant A Multi-center Single-arm Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the safety and efficacy of Single Umbilical Cord blood transplantation sUCBT containing low dose ATG based conditioning regimen in the treatment of acquired Severe Aplastic Anemia SAA
Detailed Description:
Hematopoietic stem cell transplantation HSCT from HLA-compatible sibling donors is the standard preferred therapy for Severe Aplastic Anemia SAA At present HLA-compatible donors in China fail to meet the needs of patients for transplantation Umbilical Cord blood transplantation UCBT is an alternative treatment for patients with emergency conditions who lack compatible sibling donors have failed immunosuppressant therapies or cannot wait for unrelated fully compatible donors However implantation failure is one of the main problems in UCBT for SAA due to the low cord blood stem cells Nowadays there is no consensus on the optimal conditioning regimen for UCBT treatment of SAA and whether ATG should be added to the conditioning regimen is still controversial Early clinical studies in UCBT have shown that the sufficient ATG in the conditioning regimen will lead to a decrease rate of implantation rate and affect survival of UCBT ultimately However a range of recent studies have found that with the addition of low-dose ATG T cell reconstitution seems to outperform bone marrow or peripheral blood stem cell transplantation Therefore how to properly use ATG to both retain its effective GVHD prevention effect and reduce its impact on immune reconstruction has important clinical significance for improving the transplantation efficacy In this study a multicenter clinical study will be conducted to observe the safety and efficacy of UCBT with low dose ATG in the treatment of SAA and the long-term quality of life of patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None