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Phase I-II Clinical Trial With Autologous Bone Marrow Derived Mesenchymal Stem Cells for the Therapy of Multiple Sclerosis

NCT02035514 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-12-15

No results posted yet for this study

Summary

Immunomodulatory therapies to treat the relapsing-remitting phase of multiple sclerosis (MS) are designed to ameliorate the inflammatory processes that mediate the damage to the central nervous system (CNS) and to delay progression of the disease. To date, there is no effective means to stop the progression of disease and induce remyelination. Adult stem cells therapy show great promise and is rapidly developing as alternative therapeutic strategy. We propose the use of bone marrow-derived autologous Mesenchymal (BM-MSC) Stem Cells transplantation to treat patients with relapsing-remitting MS (RRMS), despite immunomodulatory therapy. Taking advantage of the potential that MSC possess strong immunomodulatory properties thought to play a role in the maintenance of peripheral tolerance and in the control of autoimmunity and that may stimulate repair and regeneration of lesions, we plan a trial of a single injection of autologous BM-MSC into eight patients. First, we aim to assess the feasibility, safety and tolerability of autologous MSC therapy in RRMS. Second, we plan to evaluate the effects of BM-MSC transplantation on MS disease activity by clinical, neurophysiological, immunological and imaging assessments. Autologous MSC will be obtained from bone marrow aspirates, purified by culture and characterized by surface antigen expression. A single dose of autologous BM-MSC will be injected intravenously. Clinical, neurological and immunological assessments will be scheduled at baseline (before BM-MSC transplantation) at 1, 3, and 6 months after transplant. The imaging will be performed at 3 and 6 months after transplant. Proposed trial will enable us to ascertain whether autologous BM-MSC transplantation is a feasible and safe procedure, and whether BM-MSC can establish an environment of immune tolerance and through the local production of neurotrophic/growth factors, might induce neuroprotection and improvement in CNS function.

Conditions

  • Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions

BIOLOGICAL

Bone marrow autologous mesenchymal stem cells transplantation

Sponsors & Collaborators

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

    collaborator OTHER_GOV

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Cristina Ramo, PhD · Germans Trias i Pujol University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02035514 on ClinicalTrials.gov