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Autologous Mesenchymal Stromal Cells for Multiple Sclerosis

NCT02495766 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-01-21

No results posted yet for this study

Summary

This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.

Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6, the treatment will be crossed to receive the other product. The objective is to assess the safety of a single infusion BM-MSC, and to explore its efficacy in these patients.

Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.

Conditions

  • Relapsing-Remitting Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis

Interventions

DRUG

XCEL-MC-ALPHA

Single infusion

DRUG

Placebo

Single infusion

Sponsors & Collaborators

  • Vall d'Hebron Research Institute (VHIR)

    collaborator UNKNOWN

  • Banc de Sang i Teixits

    lead OTHER

Principal Investigators

  • Xavier Montalban, MD, PhD · Hospital Vall d'Hebron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-05-11
Primary Completion
2017-11-27
Completion
2018-11-15

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02495766 on ClinicalTrials.gov