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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Fludarabine 30mg/m2 for 4 days, Cyclophosphamide 50mg/kg for 2 days, Alemtuzumab administered subcutaneously 24mg total dose. Autologous bone marrow transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow transplantation | Procedure | IMMUNOABLATIVE NONMYELOABLATIVE AUTOLOGOUS BONE MARROW TRANSPLANTATION on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment parameters of Neutrophils and Platelets | Absolute Neutrophil count >500 /microliter, Platelets>20,000/microliter | 1 year |
| Transplant related mortality by Day 100 | Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Expanded Disability Status Scale (EDSS score, as compared to baseline) | 1 year | |
| Overall survival (OS) at 1 year | 1 year | |
| Progression-free survival (PFS) at 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Igor Resnick, Prof. | Contact | 972-50-787-4663 | gashka.resnick@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Igor Resnick, Prof. | Bone Marrow Transplantation, Cancer Immunotherapy & Immunobiology Research Center, Hadassah University Hospital, Ein Kerem, Jerusalem, Israel | Principal Investigator |
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| Fludarabine | Drug | 30mg/m2 on days -6 through -3 |
|
| Cyclophosphamide | Drug | 50mg/kg on days -5 through -4 |
|
| Alemtuzumab | Drug | 3mg on day -3, 9mg on day -2, 12 mg on day -1 |
|
| 1 year |
| Changes in MRI activity | T2 number | 1 year |
| Changes in MRI activity | Volume of gadolinium enhancing lesions | 1 year |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| D000074323 | Alemtuzumab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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