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NOT YET RECRUITING
NCT07137104
PHASE1/PHASE2

Safety and Preliminary Effectiveness Study of Mesenchymal Stem Cells, HeXell-2020, in Patients With Stable Coronary Artery Disease

Sponsor: Hexun Biosciences Co., LTD.

View on ClinicalTrials.gov

Summary

This is a phase I/IIa study to investigate the safety, tolerability, and preliminary effectiveness of HeXell-2020 in patients with stable coronary artery disease (CAD). 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/IIa Study to Investigate the Safety, Tolerability, and Preliminary Effectiveness of HeXell-2020 in Patients With Stable Coronary Artery Disease (CAD)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2025-12-01

Completion Date

2028-07-31

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

DRUG

HeXell-2020

Phase I Cohort 1: HeXell-2020 with a total of 3 doses, 9x10\^7 cells/dose. Phase I Cohort 2: HeXell-2020 with a total of 6 doses, 9x10\^7 cells/dose. Phase IIa: RP2D from phase I.