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

NCT07137104 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HEXUMBA20221222
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

Brief 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

Coronary Artery Disease

Keywords

HeXell-2020; Coronary Artery Disease (CAD); Mesenchymal Stem Cells (MSC)

Outcome Measures

Primary Outcomes (3)

• Incidence of TEAE, SAE and SUSAR over the study

  To evaluate the number of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), suspected and unexpected serious adverse reactions (SUSARs) over the study period,

  Within the first year after cell transplantaion

• To determine the recommended phase II dose (RP2D) in Phase I study

  To determination RP2D, number and proportion of subjects having experienced DLTs will be presented and the RP2D should be determined on the indicated dose at which ≤ 1 patient experiences DLT out of 6 patients who have been DLT evaluated.

  Within the first year after cell transplantaion

• Change in myocardial perfusion defect severity under the rest acquisition and pharmacological stress of dipyridamole in Phase IIa study

  Measured by SPECT with thallium-201 from baseline. The SRS, SSS and SDS are three variables used to measure cardiac perfusion and ischemia.

  Before first dosing and at 12 months post cell transplantaion

Secondary Outcomes (12)

• Time to the first occurrence of major adverse cardiovascular events (MACEs)

  From the date of the first treatment until the first occurrence of MACE, death, or study cut-off point, unless the subject has withdrawn consent for all contacts or is loss of follow-up, whichever came first, assessed up to 24 months.

• Change in the evaluation result of CCTA from baseline

  Before first dosing and at 3, 6 months post cell transplantation

• Change from baseline in echocardiographic measures.

  Before first dosing and at 3, 6, 12 months post cell transplantation

• Change in functional class of angina by using CCS angina classification from baseline.

  Before first dosing, and 1, 3, 6 , 12 months post cell transplantation

• Change in the 6-minute walk test (6-MWT) from baseline.

  Before first dosing and 6, 12 months post cell transplantation

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

Phase 1 ：single arm. two cohort. cohort 1: HeXell-2020 will be administered by intravenous once every two weeks, and a total of 3 doses. cohort 2: HeXell-2020 will be administered by intravenous once every two weeks, and a total of 6 doses. Phase 2a: Single arm.

Drug: HeXell-2020

Interventions

HeXell-2020 DRUG

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.

Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who is able to understand the nature of this study and accepts to enter the study by signing written informed consent
• Male or female who are aged between 18 and 75 years old on date of consent
• Patient without LV thrombus or ventricular aneurysm documented by echocardiography at screening
• Patient having a diagnosis of CAD caused by ≥ 50% stenosis of at least 1 major or larger epicardial coronary artery (target vessel ≥ 2 mm in diameter without in-stent restenosis) documented by imaging studies within 12 months prior to the date of dosing. If the stenosis results are derived from CCTA, the examination time of CCTA should be at least 6 months prior to screening.
• Patient with Canadian Cardiovascular Society (CCS) Class I, II, or III angina pectoris and received optimal, stable, medical therapy (e.g., anticoagulants therapy, β-blockers, calcium channel blockers, nitrates, ranolazine) per country specific treatment guidelines for at least 4 weeks prior to the date of screening, if prescribed
• Patients with stable hemodynamic parameters and adequate pulmonary function, defined as systolic pressure ≥ 90 mmHg and \< 150 mmHg, and heart rate \> 50/min and \<110/min on at least 2 consecutive readings, at screening and baseline (before dosing)
• Patient's medical history shows no history of organ or cell transplant rejection, or suspected contraindication to HeXell-2020 including the components (penicillin and streptomycin).
• Female subjects show negative pregnancy test results within 30 days prior to the first study treatment.
• All male patients and female patients with child-bearing potential (between puberty and 2 years after menopause) should use at least any one of the appropriate contraception methods shown below, during dosing and for at least 4 weeks after stopping study treatment.
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject.
• Combination of any two of the following listed methods: (d.1+d.2 or d.1+d.3, or d.2+d.3):
• d.1. Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception. Please refer to 8.2 Prohibited Treatments for detailed information.
• d.2. Placement of an intrauterine device (IUD) or intrauterine system (IUS). d.3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps).

You may not qualify if:

• Subject had participated in investigational drug trials and took any investigational drugs within 28 days prior to the first treatment.
• Patient is schedule to \[or has received within 180 days prior to Screening Visit\] undergo the following coronary revascularization throughout the study period:
• Coronary artery bypass grafting (CABG)
• Valve repair/replacement
• Cardiac resynchronization therapy (CRT) device
• Patient is scheduled to undergo percutaneous coronary intervention (PCI) during the trial before screening.
• Patient with high-risk or unstable acute coronary syndrome (e.g., myocardial infarction), major cardiovascular surgery (e.g., coronary valve replacement, or aortic aneurysm surgery), stroke, transient ischemic attack (TIA), carotid surgery, pulmonary embolism, or deep venous thrombosis in past 90 days prior to the date of screening
• Patient with evidence of medical condition as follows,
• Acute cardiac decompensation
• Congenital heart disease
• Significantly uncorrected valvular heart disease
• Malignant arrhythmia in the absence of a defibrillator
• Severe pulmonary disease
• Essential thrombocytosis
• Anti-phospholipid syndrome

Sponsors & Collaborators

• Hexun Biosciences Co., LTD.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Simon Huang, Dr.

CONTACT

+88633175088; simon.huang@hexunbio.com

wannhsin chen, Dr.

CONTACT

+88633175088; whsin.chen@hexunbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I: Single arm, 2 dose cohorts with dose-defining escalation Phase IIa: Single arm, with dose determined in Phase I

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 22, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: August 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share