Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

NCT00813969 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-03-30

No results posted yet for this study

Summary

The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal stem cell transplantation, involving approximately 24 ambulatory participants with relapsing forms of MS (approximately equal numbers with relapsing-remitting and secondary progressive/ progressive relapsing MS) and evidence of involvement of the anterior afferent visual system.

Conditions

  • Relapsing-Remitting Multiple Sclerosis
  • Secondary Progressive Multiple Sclerosis
  • Progressive Relapsing Multiple Sclerosis

Interventions

BIOLOGICAL

Autologous mesenchymal stem cell transplantation

A single IV infusion of up to 2 million cells per kg based on the MSC numbers achieved after culture expansion

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    collaborator OTHER
  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Jeffrey A Cohen, M.D. · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-01-31
Completion
2014-05-31

Countries

  • United States

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 NCT00813969 on ClinicalTrials.gov