Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-30 @ 12:06 AM
Study NCT ID:
NCT01235468
Status:
WITHDRAWN
Last Update Posted:
2015-12-03
First Post:
2010-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)
Sponsor:
Dr. Avichai Shimoni MD
Organization:
Study Overview
Official Title:
Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders
Status:
WITHDRAWN
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
loss of support
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.
Detailed Description:
Stem cell transplantation is a curative approach for patients with hematological malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. However, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. In this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.
Study Oversight
Has Oversight DMC:
False
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?: