EUCTR2012-002357-35-GB进行中（未招募）1 期
Stem cells in Rapidly Evolving Active Multiple Sclerosis (STREAMS) - Stem cells in Rapidly Evolving Active Multiple Sclerosis (STREAMS)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 13
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
入选标准
- •Patients with clinically and radiologically active multiple sclerosis as defined by:
- •1. Diagnosis of MS:
- •a. Relapsing remitting MS (RRMS): =1 moderate-severe relapse and =1 GEL in past 18 months or =1 moderate-severe relapse and =1 new T2 lesion in past 18 months.
- •b. Secondary progressive MS (SPMS) with an increase of =1 EDSS point (if baseline EDSS =5) or 0.5 EDSS point (if baseline EDSS =5.5), in the previous 18 months and =1 GEL in past 18 months or =1 moderate-severe relapse and =1 new T2 lesion in past 18 months.
- •c. Primary progressive MS (PPMS) patients with positive oligoclonal bands
- •(OCBs) in the cerebrospinal fluid (CSF) and an increase of =1 EDSS point (if baseline EDSS is =5.0) or 0.5 EDSS point (if baseline EDSS is =5.5), or quantifiable, objective evidence of equivalent progression in the previous 18 months and =1 GEL in past 18 months or =1 new T2 lesion in past 18 months.
- •2.Age 18 to 50 years.
- •3.Disease duration 2 to 10 years from diagnosis (inclusive).
- •4.EDSS 3.0 to 6.5 at screening evaluation.
- •5.=1 GEL on MRI within 3 months prior to harvesting.
- •6.Adequate culture of a subject’s MSCs and their release for clinical use.
- •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 13
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. RRMS without at least one severe relapse in the previous 18 months or without at least one GEL or one new T2 in the previous 18 months.
- •2. SPMS without relapses and without new lesions (GEL or T2 positive) at MRI in the last 18 months.
- •3. PPMS without positive CSF OCBs or without a GEL or new T2 lesion in the previous 18 months.
- •4. No gadolinium enhancing lesion(s) in the 3 months prior to bone marrow harvesting.
- •5. A previously ineligible patient who failed to meet the MRI requirements of the inclusion criteria will not be reviewed again even if further imaging, revealing =1 GEL, becomes available.
- •6. Failure of BM sample to generate MSCs suitable for clinical use within a specified time frame (4 weeks).
- •7. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the last 3 months.
- •8. Treatment with interferon-beta or glatiramer acetate within the last 1 month.
- •9. Treatment with alemtuzumab (campath-1H) within the last 2 years.
- •10. Prior treatment with total lymphoid irradiation and autologous or allogeneic hematopoietic stem cell transplantation.
- •11. Participation in clinical trials of any experimental drugs in the 6 months before study entry.
- •12. Corticosteroid treatment in the last 30 days.
- •13. Presence of any active or chronic infection.
- •14. Previous history of a malignancy other than basal cell carcinoma of the skin and carcinoma in situ that has been in remission for more than one year.
- •15. Severely limited life expectancy by any other co-morbid illness.
- •16. Abnormal blood counts, a history of myelodysplasia or other cytopenia.
- •17. Known pregnancy, positive urine pregnancy test at screening or risk or pregnancy (this includes patients who are unwilling to practice active contraception during the duration of the study).
- •18. Contraindication to MRI including but not limited to intracranial aneurysm clips (except Sugita), history of intra-orbital metal fragments that have not been removed by an MD (as confirmed by orbital X-Ray), pacemaker and non-MR compatible devices (e.g. heart valves, inner ear implants), history of claustrophobia or the inability of the subject to lie still on their back for a period of 1.5 hours in the MRI scanner.
- •19. An estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m2 or history or presence of renal impairment (e.g. serum creatinine clearance less than 30ml/min).
- •20. Inability to give written informed consent/comply with study procedures.
- •21. Any significant organ dysfunction or co-morbidity that the Investigators consider would put the subject at unacceptable risk by participating in the study or that would interfere with the functional assessments.
研究者
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