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NOT YET RECRUITING
NCT07144072
PHASE1

Safety and Tolerability Study of Mesenchymal Stem Cells, HeXell-2020, in Elderly Subjects With Mild to Moderate Frailty Syndrome

Sponsor: Hexun Biosciences Co., LTD.

View on ClinicalTrials.gov

Summary

This is a phase I study to investigate the safety, and Tolerability of HeXell-2020 in Elderly Subjects with Mild to Moderate Frailty Syndrome. HeXell-2020 is an investigational drug product consisting of allogenic umbilical cord mesenchymal stem cells (UCMSCs) as the drug substance. All enrolled and eligible subjects will receive HeXell-2020 treatment.

Official title: A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of HeXell-2020 Administered Intravenously in Elderly Subjects With Mild to Moderate Frailty Syndrome

Key Details

Gender

All

Age Range

60 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-01-31

Completion Date

2028-07-31

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

DRUG

HeXell-2020

Cohort 1: 5 × 10⁷ cells per dose, administered via IV infusion every 2 weeks for a total of 3 doses Cohort 2 : 5 × 10⁷ cells per dose, administered via IV infusion every 2 weeks for a total of 6 doses