Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS
NCT00813969 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2016-03-30
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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