Mesenchymal Stem Cell Transplantation in MS (CMM-EM)

Albert Saiz

Status and phase: Terminated; Phase 2

Conditions: Multiple Sclerosis

Treatments: Biological: autologous mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01228266

CMM-EM

Details and patient eligibility

About

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

Enrollment: 9 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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9 participants in 1 patient group

autologous mesenchymal stem cell

Experimental group

Description:

A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months

Treatment:

Biological: autologous mesenchymal stem cells