NCT07137104

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

A Phase I/IIa Study to Investigate the Safety, Tolerability, and Preliminary Effectiveness of HeXell-2020 in Patients With Stable Coronary Artery Disease (CAD)

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Hexun Biosciences Co., LTD. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Coronary artery disease (CAD) is the most common form of heart disease and a leading cause of mortality worldwide. It is a manifestation of myocardial ischemia, a condition resulting from insufficient blood flow to the myocardial tissue. CAD occurs when the coronary arteries become progressively narrowed and stiffened due to atherosclerosis-the accumulation of cholesterol, lipids, and plaque along the inner arterial walls. Narrowed blood vessels and increased shear stress may contribute to plaque destabilization, vessel outward remodeling, as well as increased pro-inflammatory cytokines production, leading to advanced atherosclerosis. As the disease advances, this narrowing impairs coronary blood flow, causing permanent heart damage. Over time, CAD can progressively weaken the heart muscle, contributing to heart failure. Mesenchymal stem cells (MSC) become a potential therapeutic tool for treating cardiovascular diseases due to their capabilities in tissue repair, anti-oxidation, immune-modulation and anti-inflammatory. Intravenous infusion of HeXell-2020, the allogenic umbilical cord MSC, in an atherosclerotic rat model improved blood glucose tolerance, LDL cholesterol levels, and the severity of aortic arch stenosis. Additionally, results further demonstrated significant improvement in atherosclerotic lesions caused by fat deposition at the aortic arch and descending aorta after the treatment. Although the mode of actions of MSCs in CADs have not been fully elucidated, these nonclinical results, together with the established immunomodulatory and anti-inflammatory effects of MSCs, are supportive for the rationale of HeXell-2020 in treating patients with CAD. This study is composed of two phases, Phase I and Phase IIa. In Phase I, two cohorts were designed following traditional 3+3 scheme to define recommended phae 2 dose (RP2D). In Phase IIa, 22 evaluable subjects are estimated. Safety and efficacy will be evaluated through follow-up visit over one year.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-31
• Completion: 2028-07-31
• First posted: 2025-08-22
• Last updated: 2025-08-22

Regulatory

• FDA-regulated drug study