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Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01056471
First Posted: January 26, 2010
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
  Purpose
The main purpose of this study is to evaluate the safety and feasibility of regenerative therapy with mesenchymal stem cells from adipose tissue, administered intravenously in patients with secondary progressive multiple sclerosis who do not respond to treatment.

Condition Intervention Phase
Autoimmune Diseases Immune System Diseases Demyelinating Diseases Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Other: Autologous mesenchymal stem cells from adipose tissue. Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Clinical Trial Phase I / II Randomized, Placebo-controlled Study to Evaluate Safety and Feasibility of Therapy With Two Different Doses of Autologous Mesenchymal Stem Cells in Patients With Secondary Progressive Multiple Sclerosis Who do Not Respond to Treatment

Resource links provided by NLM:


Further study details as provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells [ Time Frame: 12 months. ]

Secondary Outcome Measures:
  • To evaluate effects on MS disease activity measured by: clinical variables, imaging variables, immunological and neurophysiologic analysis, neuropsychological and quality of life scales. [ Time Frame: 12 months ]

Enrollment: 30
Study Start Date: January 2010
Study Completion Date: June 2015
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose autologous mesenchymal cells
The dose of infused cells is 10e6 cells/Kg
Other: Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.
Experimental: High dose
The dose of infused cells is 4*10e6 cells/Kg
Other: Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg.
No Intervention: Placebo Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
  2. Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
  3. Patients with treatment failure defined by: no response to immunomodulators / immunosuppressants, and showing activity in the form of 1 relapse in the last year or 0.5 points in EDSS progression.
  4. Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
  5. Patients who give written consent to participate in the study. -

Exclusion Criteria:

  1. History of current pathology or current laboratory results indicative of any severe disease.
  2. Pacemaker or metallic implants that prevent MR imaging.
  3. Inability to complete questionnaires.
  4. Refusal to give informed consent.
  5. Predicted impossibility for a biopsy of at least 30 grams of fat tissue.
  6. Positive screening test for HIV, Hepatitis B or Hepatitis C.
  7. History of malignancy.
  8. Having been in treatment with any investigational drug or have undergone any experimental procedure in the 3 months prior to baseline.
  9. Body mass index> 40 kg/m2.
  10. Patients who have been treated with prohibited concomitant medication during the month prior to inclusion in the study.
  11. Pregnancy or lactation

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056471


Locations
Spain
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41004
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Carlos III Health Institute
Investigators
Study Director: Oscar Fernandez Fernandez, MD, PhD Hospital Regional Universitario Carlos Haya, Málaga, Spain.
Principal Investigator: Guillermo Izquierdo Ayuso, MD, PhD Hospital Universitario Virgen Macarena, Sevilla, Spain
  More Information

Additional Information:
Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01056471     History of Changes
Other Study ID Numbers: CMM/EM/2008
First Submitted: January 25, 2010
First Posted: January 26, 2010
Last Update Posted: August 7, 2015
Last Verified: February 2015

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
Multiple Sclerosis
Mesenchymal Stem Cells
Autologous

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Multiple Sclerosis, Chronic Progressive
Demyelinating Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Pathologic Processes
Leukoencephalopathies
Brain Diseases
Central Nervous System Diseases