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UC-MSC in Multiple Sclerosis
NCT02034188Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2014
- Primary completion
- Mar 2016
- Countries
- 1
- Sponsor
- Translational Biosciences
- Modality
- Stem Cell Therapies
- Conditions
- multiple sclerosis (MS)
01
Overview
Phase 2, open-label, single-arm trial of human umbilical cord mesenchymal stem cells in multiple sclerosis (MS), sponsored by Translational Biosciences. Primary endpoint: Number of participants with adverse events at 12 months. Started Jan 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Umbilical cord mesenchymal stem cells
Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 7 days
03
Who it enrols
Patients 18-55 years old with clinically defined MS, EDSS 2.0-5.5, and no severe comorbidities like uncontrolled diabetes, renal failure, or active infection.
04
Endpoints
Primary
Number of participants with adverse events
Secondary
Expanded Disability Status Scale
Scripps Neurological Rating Scale
Paced Auditory Serial Addition Test
Nine Hole Peg Test
25-Foot Walk Test
Short Form 36 Quality of Life Questionnaire
Number of participants experiencing pulmonary edema
Change in brain or spinal cord lesions
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