Mesenchymal Stem Cell Transplantation in MS

Phase 2

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Biological: autologous mesenchymal stem cells

• Registration Number: NCT01228266
• Lead Sponsor: Albert Saiz

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-25
• Study First Posted: 2010-10-26
• Study Start: 2010-12
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-12
• Last Update Posted: 2014-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
autologous mesenchymal stem cell	autologous mesenchymal stem cells	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

Primary Outcome Measures

Name	Time	Method
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	The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI

Secondary Outcome Measures

Name	Time	Method
To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales	12 months	clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis

Trial Locations

Locations (1)

Neurology Service, Hospital Clinic de barcelona; 🇪🇸 Barcelona, Spain