Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis
This study has been completed.
Sponsor:
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01056471
First received: January 25, 2010
Last updated: August 4, 2015
Last verified: February 2015
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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 Andalusian Initiative for Advanced Therapies - 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 ]
| Enrollment: | 30 |
| Study Start Date: | January 2010 |
| Study Completion Date: | June 2015 |
| 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: Placebo Control |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and Locations
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01056471
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
Additional Information:
| 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 |
| Study First Received: | January 25, 2010 |
| Last Updated: | August 4, 2015 |
| Health Authority: | Spain: Spanish Agency of Medicines |
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 |
ClinicalTrials.gov processed this record on September 27, 2016