Status:
TERMINATED
Hematopoietic Stem Cell Therapy for Patients With Multiple Sclerosis
Lead Sponsor:
Northwestern University
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
Multiple sclerosis is disease believed to be due to immune cells, cells which normally protect the body, but are now attacking the tissue in the brain and possibly the spinal cord. The likelihood of p...
Eligibility Criteria
Inclusion
- Age between 18-50, inclusive.
- Diagnosis of Multiple Sclerosis (MS) using Poser criteria (Appendix A).
- An Expanded Disability Status Scale (EDSS) of 2.0 - 5.5 (Appendix B).
- Inflammatory disease despite primary disease modifying therapy with at least 3 months of interferon. Failure is defined as two or more clinical relapses with documented neurologic changes within the year prior to the study. (NOTE: Relapses must have required treatment with corticosteroids. Sensory only relapses are excluded.) Failure may also be defined as one relapse within the year prior to study if there is evidence on MRI of active inflammation (i.e., gadolinium enhancement).
Exclusion
- Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.
- Prior history of malignancy except localized basal cell, squamous skin cancer or carcinoma in situ of the cervix. Other malignancies for which the patient is judged to be cured, such as head and neck cancer, or breast cancer will be considered on an individual basis.
- Positive pregnancy test.
- Inability or unwillingness to pursue effective means of birth control. Effective birth control is defined as 1) refraining from all acts of vaginal intercourse (ABSTINENCE); 2) consistent use of birth control pills; 3) injectable birth control methods (Depo-provera, Norplant); 4) tubal sterilization or male partner who has undergone vasectomy; 5) placement of an intrauterine device (IUD); or 6) use, with every act of intercourse, of diaphragm with contraceptive jelly and/or condoms with contraceptive foam.
- Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
- Forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC) \< 60% of predicted after bronchodilator therapy (if necessary).
- Diffusing capacity of the lung for carbon monoxide (DLCO) \< 50% of predicted.
- Resting left ventricular ejection fraction (LVEF) \< 50 %.
- Bilirubin \> 2.0 mg/dl.
- Serum creatinine \> 2.0 mg/dl.
- Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins, or to iron compounds/medications.
- Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have MRI exams.
- Diagnosis of primary progressive multipole sclerosis (MS).
- Platelet count \< 100,000/ul.
- Psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible.
- Active infection except asymptomatic bacteruria.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00278655
Start Date
June 1 2003
End Date
May 1 2012
Last Update
May 1 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.