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

August 4, 2015 updated by: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga
      • Sevilla, Spain, 41004
        • Hospital Universitario Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:4*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.
Other: Autologous mesenchymal stem cells from adipose tissue.
Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.
No Intervention: Placebo Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells
Time Frame: 12 months.
12 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

January 25, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMM/EM/2008

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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