NCT02529839

Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation (BMT) in Patients With Multiple Sclerosis (MS)

Safety and Efficacy of an Immunoablative Nonmyeloablative Conditioning Protocol for Autologous Bone Marrow Transplantation in Patients With Multiple Sclerosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hadassah Medical Organization · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
PROCEDURE	Autologous bone marrow transplantation	IMMUNOABLATIVE NONMYELOABLATIVE AUTOLOGOUS BONE MARROW TRANSPLANTATION on Day 0
DRUG	Fludarabine	30mg/m2 on days -6 through -3
DRUG	Cyclophosphamide	50mg/kg on days -5 through -4
DRUG	Alemtuzumab	3mg on day -3, 9mg on day -2, 12 mg on day -1

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2015-08-20
• Last updated: 2015-08-20