Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis - Full Text View

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

This study is currently recruiting participants.

Verified September 2010 by Fundacion Progreso y Salud, Spain

First Received on January 25, 2010. Last Updated on September 21, 2010 History of Changes

Sponsor:	Fundacion Progreso y Salud, Spain
Collaborator:	Carlos III Health Institute
Information provided by:	Fundacion Progreso y Salud, Spain
ClinicalTrials.gov Identifier:	NCT01056471

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 I Phase II

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:

MedlinePlus related topics: Autoimmune Diseases Multiple Sclerosis Neurologic Diseases

U.S. FDA Resources

Further study details as provided by Fundacion Progreso y Salud, Spain:

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:

Patients diagnosed with Multiple Sclerosis (Poser and McDonald criteria).
Secondary progressive MS patients with EDSS ≥ 5.5 and ≤ 9.
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.
Patients with no MS relapse and no steroid treatment within the month prior to inclusion.
Patients who give written consent to participate in the study. -

Exclusion Criteria:

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

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Contacts and Locations

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

Fundacion Progreso y Salud, Spain

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:

Andalusian Initiative for Advanced Therapies This link exits the ClinicalTrials.gov site

Andalusian Molecular Biology and Regenerative Medicine Centre This link exits the ClinicalTrials.gov site

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 Fundacion Progreso y Salud, Spain:

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 February 09, 2012