Ignite Creation Date:
2024-05-06 @ 6:17 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05617625
Status:
SUSPENDED
Last Update Posted:
2024-07-05
First Post:
2022-11-08
Brief Title:
CD34 Enriched Transplants to Treat Myelodysplastic Syndrome
Sponsor:
Guenther Koehne
Organization:
Baptist Health South Florida
Study Overview
Official Title:
A Phase II Trial of CD34 Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Myelodysplastic Syndrome
Status:
SUSPENDED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study has been put on hold while pending CMS approval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate whether processing blood stem cell transplants using an investigational device the CliniMACS system results in fewer complications for patients who undergo transplant to treat a blood malignancy cancer or blood disorder
The CliniMACS system will be used to remove immune T-cells from the transplant donors blood Immune T-cells contribute to graft versus host disease GVHD - a serious complication that can happen after transplant GVHD occurs when a patients immune system attacks the donors cells The study aims to reduce the number of the donor immune T-cells thereby preventing or reducing the severity of GVHD
The CliniMACS system will be used to remove immune T-cells from the transplant donors blood Immune T-cells contribute to graft versus host disease GVHD - a serious complication that can happen after transplant GVHD occurs when a patients immune system attacks the donors cells The study aims to reduce the number of the donor immune T-cells thereby preventing or reducing the severity of GVHD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None