Mesenchymal Stem Cell Transplantation in MS

Multiple Sclerosis Clinical Trial

— CMM-EM  

Official title:

Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01228266
• Other study ID #: CMM-EM
• Status: Terminated
• Phase: Phase 2
• First received: October 25, 2010
• Last updated: February 12, 2014
• Start date: December 2010
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Biological:
• autologous mesenchymal stem cells
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS

Locations

Country	Name	City	State
Spain	Neurology Service, Hospital Clinic de barcelona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Albert Saiz	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI	12 months	Yes
Secondary	To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales	clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis	12 months	No