Stopped earlyPhase 2Relapsing and progressiveNCT01228266

What it found

Stopped early

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

Loading reviews and guidelines…

Related trials

History

    1. Started

      Dec 2010

    2. Main results due

      Jun 2013

    3. Finished

      Dec 2013

    Assembled by software from public sources and not checked by people. Each record links to its source. Report an error