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

NCT07137104 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-08-22

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Hexun Biosciences Co., LTD.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-31
Completion
2028-07-31
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07137104 on ClinicalTrials.gov