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Mesenchymal Stem Cells for Age-Related Frailty in Veterans
NCT05284604Phase 2
Key facts
- Status
- Withdrawn
- Start
- Jan 2023
- Primary completion
- Jan 2023
- Countries
- 1
- Sponsor
- VA Office of Research & Development
- Modality
- Stem Cell Therapies
- Conditions
- frailty syndrome
01
Overview
Phase 2, randomised trial of mesenchymal stem cells in frailty syndrome (3 arms), sponsored by VA Office of Research & Development. Primary endpoint: Adherence at 6 months. Planned start Jan 2023; status: withdrawn.
02
Design
3 arms- Study design
- Randomized
Group 1
Peripheral IV Infusion of 100 million MSCs at baseline and repeated at three months
Group 2
Peripheral IV Infusion of 100 million MSCs at baseline and peripheral IV infusion of placebo at three months
Group 3
Peripheral IV infusion of placebo at baseline and repeated at three months
03
Who it enrols
Community-dwelling older adults (65-85) with frailty (CFS 5-6, MPPT 18-31, 6MWD 200-400m), excluding those with major cardiopulmonary/neuromuscular diseases, severe renal impairment, uncontrolled diabetes/hypertension, recent malignancies, or active infections.
04
Endpoints
Primary
Adherence
Secondary
Recruitment
Modified Physical Performance Test
6-Minute Walk Test
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