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Mesenchymal Stem Cell Transplantation in MS (CMM-EM)

This study has been terminated.
(Ended the recruitment in June 2012 for low enrollement accrual)
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Albert Saiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01228266
First received: October 25, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Multiple Sclerosis
Biological: autologous mesenchymal stem cells
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI


Secondary Outcome Measures:
  • To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis


Enrollment: 9
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autologous mesenchymal stem cell
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
Biological: autologous mesenchymal stem cells
A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01228266

Locations
Spain
Neurology Service, Hospital Clinic de barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Albert Saiz
Instituto de Salud Carlos III
Investigators
Principal Investigator: Albert Saiz, MD Hospital Clinic de Barcelona
  More Information

No publications provided

Responsible Party: Albert Saiz, MD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01228266     History of Changes
Other Study ID Numbers: CMM-EM
Study First Received: October 25, 2010
Last Updated: February 12, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios (AEMPS)

Keywords provided by Hospital Clinic of Barcelona:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014