The purpose of this study is to evaluate the safety and efficacy of an immunoablative nonmyeloablative conditioning protocol for autologous bone marrow transplantation in patients with Multiple Sclerosis. Patients meeting inclusion and exclusion criteria will start an immunoablative nonmyeloablative conditioning regimen followed by autologous bone marrow transplantation. Patients will be followed for one year by a neurologist to evaluate the course of the disease after treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
IMMUNOABLATIVE NONMYELOABLATIVE AUTOLOGOUS BONE MARROW TRANSPLANTATION on Day 0
30mg/m2 on days -6 through -3
50mg/kg on days -5 through -4
3mg on day -3, 9mg on day -2, 12 mg on day -1
Engraftment parameters of Neutrophils and Platelets
Absolute Neutrophil count \>500 /microliter, Platelets\>20,000/microliter
Time frame: 1 year
Transplant related mortality by Day 100
Time frame: Day 100
Changes in the Expanded Disability Status Scale (EDSS score, as compared to baseline)
Time frame: 1 year
Overall survival (OS) at 1 year
Time frame: 1 year
Progression-free survival (PFS) at 1 year
Time frame: 1 year
Changes in MRI activity
T2 number
Time frame: 1 year
Changes in MRI activity
Volume of gadolinium enhancing lesions
Time frame: 1 year
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