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"A Phase 2, Open Label, Efficacy and Safety Study of Autologous HB-adMSCs for the Treatment of Patients With Multiple Sclerosis"
This protocol is part of a clinical study to evaluate efficacy and safety of multiple intravenous administrations of HB-adMSCs for the treatment of Multiple Sclerosis.
Details
| Lead sponsor | Hope Biosciences Research Foundation |
|---|---|
| Phase | Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 10 |
| Start date | 2025-05-02 |
| Completion | 2027-01 |
Conditions
- Relapsing Remitting Multiple Sclerosis (RRMS)
- Multiple Sclerosis
Interventions
- Autologous HB-adMSCs
Primary outcomes
- Change from Baseline in Multiple Sclerosis Quality of Life (MSQOL)-54 Instrument scores — 1 year
The MSQOL-54 is a comprehensive health-related quality of life measure incorporating general and MS-specific questions into a single instrument. The developers used the SF-36 as a base and added 18 questions to address MS-specific problems, including fatigue and cognitive function. This 54-item questionnaire provides 12 sub-scales, two summary scores, and two extra single-item measures. The sub-scales are physical function, role limits-physical, emotional role restrictions, pain, emotional well-being, energy, health perceptions, social position, cognitive function, health distress, overall quality of life, and sexual function. There is no single overall score for MSQOL-54. Two summary scores - physical health and mental health - can be derived from a weighted combination of scale scores (scale scores range from 0 to 100 and a higher scale score indicates improved quality of life).
Countries
United States