EUCTR2012-004165-41-GB进行中（未招募）1 期
Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS
orthwestern University0 个研究点目标入组 0 人开始时间: 2013年9月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age between 18-55, inclusive
- •2. Diagnosis of MS using McDonald criteria of clinically definite MS
- •3. An EDSS of 2.0 to 6.0
- •4. Inflammatory disease despite treatment with standard disease modifying therapy including at least 6 months of interferon or copaxone. Inflammatory disease is defined based on both MRI (gadolinium enhancing lesions) and clinical activity (acute relapses *treated with IV or oral high dose corticosteroids and prescribed by a neurologist).
- •Minimum disease activity required for failure is defined as: a) two or more *steroid treated clinical relapses with documented new objective signs on neurological examination documented by a neurologist and treated with steroids within the year prior to the study, or b) one *steroid treated clinical relapse within the year prior to
- •study and evidence on MRI of active inflammation (i.e., gadolinium enhancement) within the last 12 months on an occasion separate from the clinical relapse (3 months before or after the clinical relapse).
- •*A steroid treated relapse will include a relapse that was severe enough to justify treatment but due to patient intolerance of steroids, or a history of nonresponse
- •to steroids, they were offered but not used.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •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 from the time of evaluation for eligibility until 6 months posttransplant (if on transplant) or until appropriate for nontransplant treatment (if on control arm). Effective birth control is defined as 1) abstinence defined as refraining from all acts of vaginal intercourse; 2) consistent use of birth control pills; 3) injectable birth control methods (Depoprovera,
- •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. FEV1/FVC < 60% of predicted after bronchodilator therapy (if necessary)
- •7. DLCO < 50% of predicted (for the transplant arm)
- •8. Resting 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 MS
- •14. Diagnosis of secondary progressive MS
- •15. Platelet count < 100,000/ul, WBC < 1,500 cells/mm3
- •16. Psychiatric illness, mental deficiency or cognitive dysfunction making compliance with treatment or informed consent impossible
- •17. Active infection except asymptomatic bacteriuria
- •18. Use of natalizumab (Tysabri) within the previous 6 months
- •19. Use of fingolimod (Gilenya) within the previous 3 months
- •20. Use of Teriflunomide (Aubagio) within the previous 2 years unless cleared from the body (plasma concentration < 0.02mcg/ml) following elimination from the body with cholestyramine 8g three times a day for 11 days
- •21. Prior treatment with CAMPATH (alemtuzumab)
- •22. Prior treatment with mitoxantrone
- •23. Any hereditary neurological disease such as CharcotMarieTooth disease (CMT) or Spinocerebellar ataxia (SCA) are contraindications
- •24. Use of tecfidera within the previous 3 months
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