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

Primary Purpose

Autoimmune Diseases, Immune System Diseases, Demyelinating Diseases

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Autologous mesenchymal stem cells from adipose tissue.

About this trial

This is an interventional treatment trial for Autoimmune Diseases focused on measuring Multiple Sclerosis, Mesenchymal Stem Cells, Autologous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
-

Sites / Locations

Hospital Regional Universitario de Málaga
Hospital Universitario Virgen Macarena

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Low dose autologous mesenchymal cells

High dose

Placebo Control

Arm Description

The dose of infused cells is 10e6 cells/Kg

The dose of infused cells is 4*10e6 cells/Kg

Outcomes

Primary Outcome Measures

To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells

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.

Full Information

NCT ID

NCT01056471

First Posted

January 25, 2010

Last Updated

August 4, 2015

Sponsor

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

Collaborators

Carlos III Health Institute

1. Study Identification

Unique Protocol Identification Number

NCT01056471

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

Collaborators

Carlos III Health Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Diseases, Immune System Diseases, Demyelinating Diseases, Nervous System Diseases, Demyelinating Autoimmune Diseases, CNS, Autoimmune Diseases of the Nervous System

Keywords

Multiple Sclerosis, Mesenchymal Stem Cells, Autologous

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose autologous mesenchymal cells

Arm Type

Experimental

Arm Description

The dose of infused cells is 10e6 cells/Kg

Arm Title

High dose

Arm Type

Experimental

Arm Description

The dose of infused cells is 4*10e6 cells/Kg

Arm Title

Placebo Control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Autologous mesenchymal stem cells from adipose tissue.

Intervention Description

Intravenous infusion of autologous mesenchymal stem cells.Dose:4*10e6 cells/Kg.

Intervention Type

Other

Intervention Name(s)

Autologous mesenchymal stem cells from adipose tissue.

Intervention Description

Intravenous infusion of autologous mesenchymal stem cells. Dose: 10e6 cells/Kg.

Primary Outcome Measure Information:

Title

To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells

Time Frame

12 months.

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Oscar Fernandez Fernandez, MD, PhD

Organizational Affiliation

Hospital Regional Universitario Carlos Haya, Málaga, Spain.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Guillermo Izquierdo Ayuso, MD, PhD

Organizational Affiliation

Hospital Universitario Virgen Macarena, Sevilla, Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Regional Universitario de Málaga

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Universitario Virgen Macarena

City

Sevilla

ZIP/Postal Code

41004

Country

Spain

12. IPD Sharing Statement

Links:

URL

http://www.cabimer.es

Description

Andalusian Molecular Biology and Regenerative Medicine Centre

Learn more about this trial

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

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