Ignite Creation Date:
2024-05-05 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00638820
Status:
TERMINATED
Last Update Posted:
2017-12-28
First Post:
2008-03-11
Brief Title:
Reduced Intensity AlloTransplant For Osteopetrosis
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Reduced Intensity Allogeneic Transplantation For Severe Osteopetrosis Incorporating A Second Cd34 Selected Graft
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Excess toxicity
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We believe that hematopoietic stem cell transplantation HSCT will help subjects with Osteopetrosis generate functioning osteoclasts and by so doing assist in the resolution of the abnormal bone architecture and the anemia and bone marrow failure that is also characteristic of this disease However we have found in past studies that approximately 30 of Osteopetrosis patients do not engraft Therefore in this study we plan to use a different combination of pre-transplant drugs to try to make transplants safer for this disease as well as to provide a second infusion of stem cells in patients with matched related or unrelated donors The purpose of this research is to find a safer and more effective means of performing stem cell transplantation in patients with Osteopetrosis using chemotherapy and radiation designed to bring about engraftment and lessen transplant mortality
Detailed Description:
This transplant protocol will test the following 1 the ability to achieve engraftment with the reduced intensity protocol 2 the mortality associated with transplant by day 100 3 patient outcomes based on differential imaging and biologic evaluations prior to transplantation and at designated points after transplantation day 100 6 months 1 2 and 5 years Additional biologic studies will include microarray analysis Campath levels just prior to the administration of the graft and establishment of mesenchymal stem cell lines In older patients studies to evaluation osteoclast differentiation and function will also be offered
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 |
|---|---|---|---|
| MT2007-06 | OTHER | Masonic Cancer Center University of Minnesota | None |