Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Northwestern University
Age
18–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age between 18-50, inclusive.
2. Diagnosis of Multiple Sclerosis (MS) using Poser criteria (Appendix A).
3. An Expanded Disability Status Scale (EDSS) of 2.0 - 5.5 (Appendix B).
4. 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).
You may not be if
1. Any illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy.
2. 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.
3. Positive pregnancy test.
4. 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.
5. Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
6. Forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC) \< 60% of predicted after bronchodilator therapy (if necessary).
7. Diffusing capacity of the lung for carbon monoxide (DLCO) \< 50% of predicted.
8. Resting left ventricular ejection fraction (LVEF) \< 50 %.
9. Bilirubin \> 2.0 mg/dl.
10. Serum creatinine \> 2.0 mg/dl.
11. Known hypersensitivity to mouse, rabbit, or E. Coli derived proteins, or to iron compounds/medications.
12. Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have MRI exams.
13. Diagnosis of primary progressive multipole sclerosis (MS).
14. Platelet count \< 100,000/ul.
15. Psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible.
16. Active infection except asymptomatic bacteruria.
Clareo Health | Hematopoietic Stem Cell Therapy for Patients With Multiple Sclerosis
