Ignite Creation Date:
2024-05-06 @ 2:57 AM
Last Modification Date:
2024-10-26 @ 11:25 AM
Study NCT ID:
NCT02162511
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2014-06-10
Brief Title:
CD34 Cell Enriched and T Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Mismatched Related Donors or Borderline Organ Function
Sponsor:
Rajni Agarwal
Organization:
Stanford University
Study Overview
Official Title:
An Expanded Access Study Using the CliniMACS System to Offer Therapeutic Manipulated Grafts That Are CD34 Cell Enriched and T Cell Depleted for Allogeneic Stem Cell Recipients With Mismatched Related Donors or Borderline Organ Function
Status:
COMPLETED
Status Verified Date:
2023-05
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:
The purpose of this protocol is to provide access to the CliniMACS System to hematopoietic cell transplant HSCT patients who do not have a matched related donor The CliniMACS system is currently approved for use in patients who have AML and a genetically matched sibling donor Through this protocol the investigators will be able to offer potentially life-saving transplants to patients who have genetically mis-matched donor who have no other options for treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None