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

Albert Saiz1 site in 1 country9 target enrollmentDecember 2010

ConditionsMultiple Sclerosis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Albert Saiz
Enrollment: 9
Locations: 1
Primary Endpoint: 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
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Albert Saiz

Responsible Party

Sponsor Investigator

Principal Investigator

Albert Saiz

Hospital Clinic of Barcelona

Eligibility Criteria

Inclusion Criteria

•Inflammatory forms of MS
•Relapsing-remitting MS (RRMS) patients
•Secondary progressive MS (SPMS) patients with continued relapses
•Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)
•Age 18-50 years
•Disease duration \>= 2 and \>= 10 years
•EDSS 3.0 - 6.5
•Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:
•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
•\>= 1 moderate-severe relapses in past 18 months

Exclusion Criteria

•SPMS without ongoing relapses
•PPMS without positive CSF or Gadolinium enhancing lesions
•\<= 3 months since treatment with any immunosuppressive therapy
•\<=1 month since last treatment with interferon-B or glatiramer acetate
•Corticosteroid treatment \<= 30 days
•Relapse \<= 60 days
•History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C
•Any metallic or electronic device that precludes from undergoing MRI
•Pregnancy or lactation
•Current treatment with an investigational therapy

Outcomes

Primary Outcomes

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

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