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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
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
Study Start Date :	January 2010
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: 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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Andalusian Molecular Biology and Regenerative Medicine Centre 

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 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