Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis (CMM/EM/2008)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fundación Pública Andaluza Progreso y Salud.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by:
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01056471
First received: January 25, 2010
Last updated: September 21, 2010
Last verified: September 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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. ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated 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: Control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01056471

Contacts
Contact: Ana - Cardesa +34 95 501 90 40

Locations
Spain
Hospital Regional Universitario Carlos Haya Recruiting
Málaga, Spain, 29010
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41004
Sponsors and Collaborators
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:
No publications provided

Responsible Party: Juan Jesús Bandera, Fundacion Progreso y Salud, Spain.
ClinicalTrials.gov Identifier: NCT01056471     History of Changes
Other Study ID Numbers: EudraCT: 2008-004015-35
Study First Received: January 25, 2010
Last Updated: September 21, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Multiple Sclerosis
Mesenchymal Stem Cells
Autologous

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

ClinicalTrials.gov processed this record on September 14, 2014