CMM-EM
What it found
The trial ended early for another reason (see below).
Reason given: Ended the recruitment in June 2012 for low enrollement accrual
What was tested
Treatment tested
- autologous mesenchymal stem cells
What it measured
Main measures
To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study
12 months
MRI lesionsSafety
Other measures (1)
To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales
12 months
Disability progressionRelapsesMRI lesionsRetina scans (OCT)Quality of life (reported by participants)
Who could take part
Relapsing and progressive · 18 to 50
Inclusion Criteria: 1. Inflammatory forms of MS 1. Relapsing-remitting MS (RRMS) patients 2. Secondary progressive MS (SPMS) patients with continued relapses 3. Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding) 2. Age 18-50 years 3. Disease duration >= 2 and >= 10 years 4. EDSS 3.0 - 6.5 5. Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by: 1. Increase of >= 1 EDSS point (if baseline EDSS \<= 5.0) or 0.5 EDSS points (if baseline EDSS >= 5.5), or quantifiable, objective evidence of equivalent progression 2. >= 1 moderate-severe relapses in past 18 months 3. >= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium) 4. >= 1 new T2 lesion 5. For PPMS only, >= 1 Gadolinium enhancing lesions 6. Has given informed consent to participate in the study. Exclusion Criteria: 1. SPMS without ongoing relapses 2. PPMS without positive CSF or Gadolinium enhancing lesions 3. \<= 3 months since treatment with any immunosuppressive therapy 4. \<=1 month since last treatment with interferon-B or glatiramer acetate 5. Corticosteroid treatment \<= 30 days 6. Relapse \<= 60 days 7. History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C 8. Any metallic or electronic device that precludes from undergoing MRI 9. Pregnancy or lactation 10. Current treatment with an investigational therapy
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis
Papers
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History
Started
Dec 2010
Main results due
Jun 2013
Finished
Dec 2013
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