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Mesenchymal Cells From Autologous Bone Marrow, Administered Intravenously in Patients Diagnosed With Multiple Sclerosis

NCT01745783 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-04-06

No results posted yet for this study

Summary

This is a phase I / II for the evaluation of the safety and feasibility of intravenous infusion of mesenchymal cells from autologous bone marrow in patients with Multiple Sclerosis.

Intravenous administration of autologous mesenchymal cells of bone marrow is feasible and safe and can be effective in treating patients suffering from multiple sclerosis.

Conditions

Interventions

OTHER

Bone marrow mesenchymal stem cells autologous

Infusion of mesenchymal cells from autologous bone marrow in a dose of 1-2x106 cells / kg

OTHER

Placebo comparator

Lactated Ringer's solution, 2.5% glucose and 1% human albumin.

Sponsors & Collaborators

  • Iniciativa Andaluza en Terapias Avanzadas

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Guillermo Izquierdo, MD · Section Chief of Neurology, University Hospital Virgen Macarena, Spain

  • Eduardo Agüera, MD · Section of Neurology, University Hospital Reina Sofía, Spain

  • Victoria Fernández, MD · Section of Neurophysiology, University Regional Hospital Carlos Haya, Spain

  • Inmaculada Concepción Herrera, MD · Technical Director of the Cell Therapy Unit, University Hospital Reina Sofia, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT01745783 on ClinicalTrials.gov