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Autologous Stem Cell Transplant for Multiple Sclerosis

NCT01099930 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-09-28

No results posted yet for this study

Summary

Multiple sclerosis is an autoimmune disease. We are studying whether high dose chemotherapy and autologous stem cell transplant can replace the autoreactive immune system and if this reduces clinical inflammatory disease in the central nervous system (CNS). A second goal is to examine whether there is long-term stabilization or improvement in disability scores if the inflammatory disease is controlled.

Conditions

Interventions

OTHER

immuno-ablation and autologous CD34 selected hematopoietic stem cell transplantation (HSCT),

Stem Cell Mobilization with Cyclophosphamide 4.5 gm/m2 and rhGCSF 10 ug/kg/d x 10 day. Stem Cell Collection with Cobe Spectra Stem Cell Purification with Miltenyi CliniMACS Stem Cell Transplant Conditioning with Busulphan 9.6 mg/kg iv, Cyclophosphamide 200 mg/kg iv, rabbit ATG 5 mg/kg iv followed by CD34 selected autologous hematopoietic stem cell transplant

OTHER

Standard Therapy

Patient will receive standard therapy as decided upon by their treating neurologist.

Sponsors & Collaborators

  • Multiple Sclerosis Scientific Research Foundation

    collaborator UNKNOWN

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Harold L Atkins, MD · Ottawa Hospital Research Institute

  • Mark S Freedman, MD · Ottawa Hospital Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2012-11-30
Completion
2016-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01099930 on ClinicalTrials.gov