Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040482
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2002-06-26
Brief Title:
High Dose ChemoRadiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Intensive Immunosuppression Followed by Rescue With CD34 Selected T Cell Depleted Leukopheresis Products in Patients With Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple Sclerosis is a disease that may be caused by the immune system reacting against the nervous system It is possible that by changing the immune system we can modify the progression of this disease In this study we will try to learn whether treatment with a bone marrow transplant BMT can help patients with multiple sclerosis We will also try to learn what the side effects are of this treatment in patients with multiple sclerosis
Detailed Description:
To participate in this study patients will need to have a central line a thin plastic catheter or tube that is placed during surgery into one of the large veins in the neck or chest Central lines are used to give intravenous medications or to draw blood Before the transplant we will test the patients blood for viruses which can cause problems after the transplant These viruses include Hepatitis B which causes liver damage cytomegalovirus which causes lung disease and HIV which causes AIDS If a patient is positive for the AIDS virus they will not be able to undertake the transplant In addition to these blood tests patients will also have an MRI where pictures are created using magnetic rather than x-ray energy of the brain and other evaluations that are standard for any patient before having a transplant
Before the transplant patients will receive daily G-CSF Neupogen This medicine will help to stimulate the production of white blood cells WBC that will be used for the bone marrow transplant In addition 6 tablespoons of blood will be collected to look at how the immune system is functioning before and after transplant After the white blood cells have reached a certain level patients will undergo leukapheresis Leukapheresis is a procedure where blood is removed from a patients arm pumped into a machine where the white blood cells are separated from most of the other cells then returned to the patient through the same needle or through a needle in the other arm After collection of the white blood cells we will use a device in the lab to select out certain types of white blood cells CD34
After leukapheresis patients will receive an antibody from horses called Atgam ATG to help destroy the immune system and also a drug called cyclophosphamide After this radiation treatment will be given to the entire body This will be done 2 times a day for 3 days This treatment will kill most of the blood-forming cells in the bone marrow We will then give the CD34 white blood cells that were collected during leukapheresis
Blood will be collected for immune reconstitution studies monthly for 3 months and at 6 9 and 12 months after transplant to look at how the immune system is functioning The amount of blood taken will be no more than 90ml 6 tablespoons After the first year of treatment patients will continue to have 90ml 6 tablespoons of blood taken for immune reconstitution studies every 6 months for 2 more years
Before the transplant patients will receive daily G-CSF Neupogen This medicine will help to stimulate the production of white blood cells WBC that will be used for the bone marrow transplant In addition 6 tablespoons of blood will be collected to look at how the immune system is functioning before and after transplant After the white blood cells have reached a certain level patients will undergo leukapheresis Leukapheresis is a procedure where blood is removed from a patients arm pumped into a machine where the white blood cells are separated from most of the other cells then returned to the patient through the same needle or through a needle in the other arm After collection of the white blood cells we will use a device in the lab to select out certain types of white blood cells CD34
After leukapheresis patients will receive an antibody from horses called Atgam ATG to help destroy the immune system and also a drug called cyclophosphamide After this radiation treatment will be given to the entire body This will be done 2 times a day for 3 days This treatment will kill most of the blood-forming cells in the bone marrow We will then give the CD34 white blood cells that were collected during leukapheresis
Blood will be collected for immune reconstitution studies monthly for 3 months and at 6 9 and 12 months after transplant to look at how the immune system is functioning The amount of blood taken will be no more than 90ml 6 tablespoons After the first year of treatment patients will continue to have 90ml 6 tablespoons of blood taken for immune reconstitution studies every 6 months for 2 more years
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 |
|---|---|---|---|
| Multiple Sclerosis | None | None | None |