Mesenchymal Stem Cell Transplantation in MS

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01228266
• Date of registration: 25/10/2010
• Prospective Registration: Yes
• Primary sponsor: Albert Saiz
• Public title: Mesenchymal Stem Cell Transplantation in MS CMM-EM
• Scientific title: Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study
• Date of first enrolment: December 2010
• Target sample size: 9
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01228266
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Spain

Contacts

• Name: Albert Saiz, MD
• Affiliation: Hospital Clinic de Barcelona

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Biological: autologous mesenchymal stem cells

Primary Outcome(s)

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 [Time Frame: 12 months]

Secondary Outcome(s)

To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales [Time Frame: 12 months]

Secondary ID(s)

CMM-EM

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Instituto de Salud Carlos III