Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176878
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-09-12
Brief Title:
Stem Cell Transplant for Bone Marrow Failure Syndromes
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Bone Marrow Transplantation for Non-Malignant Congenital Bone Marrow Failure Disorders
Status:
COMPLETED
Status Verified Date:
2017-12
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 researchers hypothesize that it will be possible to perform unrelated bone marrow or cord blood transplants in a safer manner by using less intensive therapy yet still achieve an acceptable level of donor cell engraftment for non-malignant congenital bone marrow failure disorders
Detailed Description:
Prior to transplantation subjects will receive the drugs busulfan orally or through the catheter as well as fludarabine and anti-thymocyte globulin ATG via the catheter Busulfan fludarabine and ATG will be given with Total Lymphoid Irradiation TLI to help the new donor bone marrow take and grow after transplantation
Those patients receiving donor marrow will have the T cells a type of white blood cell in the donor marrow removed to lower the risk that the new marrow will react to their body a condition called Graft-Versus-Host-Disease GVHD After bone marrow transplantation subjects will receive drugs to help prevent GVHD including cyclosporin and mycophenolate mofetil MMF
Blood samples are taken at day 28 day 60 day 100 1 year and as required by medical status yearly for five years after transplant to evaluate how well the new marrow is growing A bone marrow biopsy is required at day 21 at day 100 and 1 year
Those patients receiving donor marrow will have the T cells a type of white blood cell in the donor marrow removed to lower the risk that the new marrow will react to their body a condition called Graft-Versus-Host-Disease GVHD After bone marrow transplantation subjects will receive drugs to help prevent GVHD including cyclosporin and mycophenolate mofetil MMF
Blood samples are taken at day 28 day 60 day 100 1 year and as required by medical status yearly for five years after transplant to evaluate how well the new marrow is growing A bone marrow biopsy is required at day 21 at day 100 and 1 year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 9504M09637 | OTHER | IRB University of Minnesota | None |