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Trial intelligence / Profile preview
Lomecel-B in Aging Frailty
NCT03169231Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2017
- Primary completion
- Sep 2021
- Countries
- 1
- Sponsor
- Longeveron
- Modality
- Stem Cell Therapies
- Drugs
- laromestrocel
- Conditions
- frailty syndrome
01
Overview
Phase 2, randomised, double-blind trial of laromestrocel in frailty syndrome (5 arms), sponsored by Longeveron. Primary endpoint: Change from baseline in 6 Minute Walk Test at 180 days. Started Jul 2017; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
25M Laromestrocel
Single IV infusion of 25 million cells
50M Laromestrocel
Single IV infusion of 50 million cells
100M Laromestrocel
Single IV infusion of 100 million cells
200M Laromestrocel
Single IV infusion of 200 million cells
Placebo
Single IV infusion of placebo
03
Who it enrols
Older adults (70-85 years) with mild to moderate frailty (CSHA Clinical Frailty Scale 5-6), reduced functional mobility (6MWT 200-400m), and elevated inflammation (TNF-alpha > 2.5 pg/mL).
04
Endpoints
Primary
Change from baseline in 6 Minute Walk Test
Secondary
Change in PROMIS-Physical Function-Short Form 20a
Change in TNF-alpha
05
Results
Not all primary endpoints met
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