High Dose Chemo/Radiotherapy and Hematopoietic Stem Cell Transplant for Patients With Multiple Sclerosis
|Multiple Sclerosis||Drug: Cyclophosphamide Drug: ATG Drug: MESNA Procedure: Radiation therapy||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intensive Immunosuppression Followed by Rescue With CD34 Selected, T Cell Depleted, Leukopheresis Products in Patients With Multiple Sclerosis|
|Study Start Date:||April 1999|
|Estimated Study Completion Date:||August 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040482
|United States, Texas|
|The Methodist Hospital|
|Houston, Texas, United States, 77030|
|Study Chair:||Malcolm K. Brenner, MD||Baylor College of Medicine|