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The Design and Rationale of a Phase 2b, Randomized, Double-Blinded, and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B in Older Adults with Frailty.
Yousefi, K; Ramdas, K N; Ruiz, J G; Walston, J; Arai, H; Volpi, E; Newman, A B; Wang, C; Hitchinson, B; McClain-Moss, L; Diaz, L; Green, G A; Hare, J M; Oliva, A A.
  • Yousefi K; Anthony A. Oliva, Longeveron Inc. 1951 NW 7th Ave., Suite 520, Miami, FL 33136, USA; aoliva@longeveron.com.
J Frailty Aging ; 11(2): 214-223, 2022.
Article in English | MEDLINE | ID: covidwho-1811430
ABSTRACT

BACKGROUND:

Frailty in older adults is a rapidly growing unmet medical need. It is an aging-related syndrome characterized by physical decline leading to higher risk of adverse health outcomes.

OBJECTIVES:

To evaluate the efficacy of Lomecel-B, an allogeneic medicinal signaling cell (MSC) formulation, in older adults with frailty.

DESIGN:

This multicenter, randomized, parallel-arm, double-blinded, and placebo-controlled phase 2b trial is designed to evaluate dose-range effects of Lomecel-B for frailty on physical functioning, patient-reported outcomes (PROs), frailty status, and biomarkers.

SETTING:

Eight enrolling clinical research centers, including the Miami Veterans Affairs Medical Center.

PARTICIPANTS:

Target enrollment is 150 subjects aged 70-85 years of any race, ethnicity, or gender. Enrollment criteria include a Clinical Frailty Score of 5 ("mild") or 6 ("moderate"), a 6MWT of 200-400 m, and serum tumor necrosis factor-alpha (TNF-α) ≥2.5 pg/mL. INTERVENTION A single intravenous infusion of Lomecel-B (25, 50, 100, or 200 million cells) or placebo (N=30/arm). Patients are followed for 365 days for safety, and the efficacy assessments performed at 90, 180, and 270 days. MEASUREMENTS The primary endpoint is change in 6MWT in the Lomecel-B-treated arms versus placebo at 180 days post-infusion. Secondary and exploratory endpoints include change in 6MWT and other physical function measures at all time points; PROs; frailty status; cognitive status; and an inflammatory biomarkers panel. A pre-specified sub-study examines vascular/endothelial biomarkers. Safety is evaluated throughout the trial.

RESULTS:

The trial is conducted under a Food and Drug Administration Investigational New Drug (IND), with Institutional Review Board approval, and monitoring by an NIH-appointed independent Data Safety Monitoring Board.

CONCLUSION:

This clinical trial investigates the use of a regenerative medicine strategy for frailty in older adults. The results will further the understanding of the potential for Lomecel-B in the geriatric condition of frailty.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Frailty / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Aged / Humans Language: English Journal: J Frailty Aging Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Frailty / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Limits: Aged / Humans Language: English Journal: J Frailty Aging Year: 2022 Document Type: Article