Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176917
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2005-09-12
Brief Title:
Stem Cell Transplantation for Hurler
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Hematopoietic Stem Cell Transplantation for Hurler Syndrome Maroteaux Lamy Syndrome MPS VI and Alpha Mannosidase Deficiency Mannosidosis
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 purpose of this study is to determine the safety and engraftment of donor hematopoietic cells using this conditioning regimen in patients undergoing a hematopoietic blood forming cell transplant for Hurler syndrome Maroteaux Lamy syndrome Mannosidosis or I-cell disease
Detailed Description:
Prior to transplantation subjects will receive Busulfan intravenously IV via the Hickman line four times daily for 4 days Cyclophosphamide intravenously via the Hickman line once a day for 4 days and Anti-Thymocyte Globulin IV via the Hickman line twice daily for three days before the transplant These three drugs are being given to subjects to help the new marrow take and grow
On the day of transplantation the donors hematopoietic cells will be transfused via central venous catheter
After hematopoietic cell transplant subjects will then receive two drugs cyclosporin and either methylprednisolone or Mycophenolate Mofetil MMF Cyclosporin and methylprednisolone or MMF are given to help prevent the complication of graft-versus-host disease and to decrease the chance that the new donor cells will be rejected
On the day of transplantation the donors hematopoietic cells will be transfused via central venous catheter
After hematopoietic cell transplant subjects will then receive two drugs cyclosporin and either methylprednisolone or Mycophenolate Mofetil MMF Cyclosporin and methylprednisolone or MMF are given to help prevent the complication of graft-versus-host disease and to decrease the chance that the new donor cells will be rejected
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 |
|---|---|---|---|
| 0104M93821 | OTHER | IRB University of Minnesota | None |