Status:
COMPLETED
Immunological Mechanisms of Hematopoietic Stem Cell Transplantation in Multiple Sclerosis
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Our goal is the elucidation of the mechanisms of action of autologous hematopoietic stem cell transplant (HSCT) and immunoablation by high-dose cyclophosphamide in multiple sclerosis (MS). The molecu...
Detailed Description
Our goal is the elucidation of the mechanisms of action of autologous hematopoietic stem cell transplant (HSCT) and immunoablation by high-dose cyclophosphamide in multiple sclerosis (MS). The molecu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Males and females between the ages of 18 and 70 years, inclusive.
- Diagnosis of clinically definite MS according to the McDonald Criteria.
- Must have been on conventional immunomodulatory treatment (interferon beta or glatiramer acetate for at least 3 months OR have not tolerated conventional treatment OR have refused to start conventional treatment).
- Two or more total gadolinium enhancing lesions on each of two pretreatment MRI scans at screening and enrollment OR one large enhancing lesion measuring at least 1 cm refractory treatment with IV steroids on each of the two pre-treatment scans.
- Subject must have EDSS ranging from 1.5 to 6.5.
- Subject must have had at least one clinical exacerbation in the last year, and this must have occurred after having been on Avonex, Betaseron, Copaxone or Rebif therapy for at least 3 months. This does not apply if subject has refused to start conventional therapy.
- Subject must have had a sustained (greater than or equal to 3 months) increase of greater than or equal to 1.0 on the EDSS (historical estimate allowed) between 1.5 and 5.5 or greater than or equal to 0.5 between 5.5 and 6.5 in the preceding year.
- Written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
- Women of childbearing potential should have a negative pregnancy test prior to entry in to the study.
- EXCLUSION CRITERIA:
- Any risk of pregnancy - ALL female patients must have an effective means of birth control or be infertile due to hysterectomy, fallopian tube surgery, or premature menopause.
- Cardiac ejection fraction of less than 45 percent.
- Serum creatinine greater than 2.0.
- Patients who are pre-terminal or moribund.
- Bilirubin greater than 2.0, transaminases greater than 2 times normal.
- Patients with EDSS less than 1.5 or greater than 6.5.
- Patients with pacemakers or implants who cannot get serial MRIs.
- Patients with active infections until infection is resolved.
- Patients with WBC count less than 3000 cells per microliter, platelets less than 100,000 cells per microliter and untransfused hemoglobin less than 10 grams per deciliter.
Exclusion
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 4 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00342134
Start Date
May 1 2002
End Date
May 4 2011
Last Update
July 2 2017
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
Johns Hopkins University
Baltimore, Maryland, United States, 21205