Information for Physicians

HALT-MS is an NIH-sponsored clinical trial evaluating autologous stem cell transplantation for poor prognosis MS.

Study Protocol

Peripheral blood stem cells (CD34+) are mobilized with G-CSF and prednisone, and collected.

Between 7-14 days later, participants are treated with a intensive conditioning regimen of BEAM (carmustine, etoposide, cytosine arabinoside and melphalan) + Thymoglobulin. The BEAM protocol followed by CD34-selected stem cell transplantation. Participants will remain hospitalized until the recovery of peripheral blood cell counts.

In a recently published Italian study, 18 of 19 patients with high disease activity and sustained clinical deterioration showed clinical stabilization or improvement following BEAM/rATG and autologous HCT ^[1].

Eligibility

The study is open to individuals 18-60 years of age, who:

• were diagnosed with relapsing-remitting or progressive-relapsing MS less than 15 years ago
  
  
• are able to walk without an assistive device
  
  
• have had two (2) or more relapses within the past 18 months while on therapy
  
  
• have had worsening MRIs over the past 2 years

Patients with primary progressive MS or secondary progressive MS without relapses for 12 or more months are not eligible. Patients must not have HIV, active hepatitis B or C infection or cirrhosis to be eligible.

*** ENROLLMENT IN the Halt-MS Study is NOW CLOSED ***

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[1] Saccardi, R. et al., Autologous HSCT for severe progressive multiple sclerosis in a multicenter trial: impact on disease activity and quality of life. Blood, 2005. 105(6): p. 2601-7