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

• Sponsor: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud (Other)
• Overall Status: Completed
• CT.gov ID: NCT01056471
• Collaborator: Carlos III Health Institute (Other)
• Enrollment: 30
• Locations: 2
• Arms: 3
• Duration (Months): 65
• Patients Per Site: 15
• Patients Per Site Per Month: 0.2

Study Details

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.

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.; Other: Autologous mesenchymal stem cells from adipose tissue.	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• 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: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Regional Universitario de Málaga	Málaga		Spain	29010
2	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Andalusian Molecular Biology and Regenerative Medicine Centre

Publications

None provided.

• Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• ClinicalTrials.gov Identifier: NCT01056471
• Other Study ID Numbers: CMM/EM/2008
• First Posted: Jan 26, 2010
• Last Update Posted: Aug 7, 2015
• Last Verified: Feb 1, 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: Multiple Sclerosis; Nervous System Diseases; Multiple Sclerosis, Chronic Progressive; Demyelinating Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases; Immune System Diseases; Sclerosis

Study Results

No Results Posted as of Aug 7, 2015