Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT01056471 |
Recruitment Status
:
Completed
First Posted
: January 26, 2010
Last Update Posted
: August 7, 2015
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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
Tracking Information | |||||||
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First Submitted Date ICMJE | January 25, 2010 | ||||||
First Posted Date ICMJE | January 26, 2010 | ||||||
Last Update Posted Date | August 7, 2015 | ||||||
Study Start Date ICMJE | January 2010 | ||||||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells [ Time Frame: 12 months. ] | ||||||
Original Primary Outcome Measures ICMJE |
To evaluate safety and tolerability related to the intravenous infusion of autologous mesenchymal stem cells [ Time Frame: 24 hr, 8 days, 1, 2, 3, 6, 9 and 12 months. ] | ||||||
Change History | Complete list of historical versions of study NCT01056471 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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 ] | ||||||
Original Secondary Outcome Measures ICMJE |
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: 24 hr, 8 days, 1, 2, 3, 6, 9 and 12 months ] | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Autologous Mesenchymal Stem Cells From Adipose Tissue in Patients With Secondary Progressive Multiple Sclerosis | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
30 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | June 2015 | ||||||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Spain | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01056471 | ||||||
Other Study ID Numbers ICMJE | CMM/EM/2008 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | ||||||
Study Sponsor ICMJE | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | ||||||
Collaborators ICMJE | Carlos III Health Institute | ||||||
Investigators ICMJE |
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PRS Account | Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | ||||||
Verification Date | February 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |