Coronary Artery DiseasePhase 1/2NCT07137104
Safety and Preliminary Effectiveness Study of Mesenchymal Stem Cells, HeXell-2020, in Patients With Stable Coronary Artery Disease
A Phase 1/2 study testing HeXell-2020 in people with Coronary Artery Disease, run by Hexun Biosciences Co., LTD. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- HeXell-2020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Aug 2026to 31 Jul 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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).
Who cannot join
- 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.
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- 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
- Other hypercoagulable disorders (e.g., disseminated intravascular coagulation, Factor V Leiden)
- Patient with poorly controlled diabetes mellitus (HbA1c >8%) or a known history or present evidence of conditions that may affect study assessments (e.g., currently receiving chemotherapeutic or immunosuppressant agents, or have received prior radiation therapy to the chest)
- Patient carry history of malignancy of any organ system (other than curatively treated localized basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder cancer) within 5 years prior to study entry.
- Subject had a history of drug abuse or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria.
- Evidence of inadequate hematopoietic, hepatic, and renal function as determined by any one of the following laboratory requirements:
- Hemoglobin <8.5 mg/dL
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 as calculated by the Modified in Diet in Renal Disease (MDRD) formula or requiring dialysis prior to study dosing.
- Total bilirubin >2× upper limit of normal (ULN)
- Alanine aminotransferase (ALT) >3× ULN
- Patient with HIV, active HBV, or active HCV infections
- Subject who is pregnant or lactating
- Subject with underlying medical, mental or psychological conditions that would impair the treatment compliance, unable to undergo study-required tests/scans for any reason, or in the opinion of the investigator would not permit to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
New Taipei City, Banqiao Dist, 220216
Wannhsin Chen, +886-3-3175088#6688, whsin.chen@hexunbio.com
Yen-Wen Wu
About this study
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)
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.
Read the 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
- Being tested
- HeXell-2020
- Keywords
- HeXell-2020, Coronary Artery Disease (CAD), Mesenchymal Stem Cells (MSC)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeXell-2020Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: HeXell-2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 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.
Measured: 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.
Measured: Before first dosing and at 12 months post cell transplantaion
Secondary outcomes (12)
Time to the first occurrence of major adverse cardiovascular events (MACEs)
Including AMI, stroke, cardiovascular mortality, and hospitalization for unstable angina or revascularization procedures, from the date of the first treatment will be analyzed by Kaplan-Meier method.
Measured: 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
The stenosis percent of the different coronary segments, using the 17-segment model.
Measured: Before first dosing and at 3, 6 months post cell transplantation
Change from baseline in echocardiographic measures.
Ventricular remodeling: including LVEF in percentage, global longitudinal strain (GLS) in percentage.
Measured: 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.
Change in functional class of angina by using CCS angina classification will be summarized descriptively by visit
Measured: Before first dosing, and 1, 3, 6 , 12 months post cell transplantation
Change in the 6-minute walk test (6-MWT) from baseline.
The 6-MWT measures the distance walked on level ground in 6 minutes.
Measured: Before first dosing and 6, 12 months post cell transplantation
Change in serum levels of amino-terminal pro-brain natriuretic peptide (NT pro-BNP) and high sensitivity cardiac troponin (hs-cTn) from baseline.
Change in serum levels of NT pro-BNP and hs-cTn from baseline will be summarized descriptively.
Measured: Before first dosing, and 1, 3, 6 , 12 months post cell transplantation
Change in quality of life using the Seattle Angina Questionnaire (SAQ) from baseline.
The SAQ, a 19-item self-administered questionnaire measuring 5 dimensions of CAD: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception will be used to assess the functional change of CAD in HeXell-2020 administered patients.
Measured: Before first dosing, and 1, 3, 6 , 12 months post cell transplantation
Change from baseline in echocardiographic measures.
Myocardial performance [including isovolumic relaxation time (IVRT), isovolumic contraction time (IVCT), LV ejection time (ET), and myocardial performance index (MPI or Tei Index)][MPI= (IVCT+IVRT)/ET]
Measured: Before first dosing and at 3, 6, 12 months post cell transplantation
Change in the evaluation result of CCTA from baseline
Severity of stenosis assessed by 2022 Coronary Artery Disease Reporting and Data System (CAD-RADSTM 2.0), ranging from CAD-RADS 0 for absence of any plaque or stenosis to CAD-RADS 5 for the presence of at least 1 totally occluded coronary artery.
Measured: Before first dosing and at 3, 6 months post cell transplantation
Change in the evaluation result of CCTA from baseline
Coronary artery calcium score (CACS, as per Agatston method, J Am Coll Cardiol. 1990;15:827-32), higher scores mean a worse outcome.
Measured: Before first dosing and at 3, 6 months post cell transplantation
Change from baseline in echocardiographic measures.
Ventricular remodeling: LV end-diastolic volume (EDV) in mL, and end-systolic volume (ESV) in mL, stroke volume (SV in ), calculated by EDV - ESV ( mL)
Measured: Before first dosing and at 3, 6, 12 months post cell transplantation.
Change from baseline in echocardiographic measures.
Ventricular remodeling: LV internal diameter in diastole and systole (LVIDd and LVIDs in mm), interventricular septum diameter (IVSD in mm), posterior wall thickness (PWT in mm), anteroseptal wall thickness (ASWT in mm)
Measured: Before first dosing and at 3, 6, 12 months post cell transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start27 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Phase I: Single arm, 2 dose cohorts with dose-defining escalation Phase IIa: Single arm, with dose determined in Phase I
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hexun Biosciences Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137104
- Sponsor's protocol ID
- HEXUMBA20221222
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07137104
- Acronym / sponsor ID
- HEXUMBA20221222
- Conditions
- Coronary Artery Disease
- Keywords
- HeXell-2020, Coronary Artery Disease (CAD), Mesenchymal Stem Cells (MSC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Hexun Biosciences Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I: Single arm, 2 dose cohorts with dose-defining escalation Phase IIa: Single arm, with dose determined in Phase I
| Arm | Type | Receives |
|---|---|---|
| Treatment Cohort | Experimental | Drug: HeXell-2020Phase 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (27 listed)
- 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:
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeXell-2020Phase 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. | Drug | Treatment Cohort |
Primary outcome
Incidence of TEAE, SAE and SUSAR over the study
Time frame: Within the first year after cell transplantaion
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,
To determine the recommended phase II dose (RP2D) in Phase I study
Time frame: Within the first year after cell transplantaion
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.
Change in myocardial perfusion defect severity under the rest acquisition and pharmacological stress of dipyridamole in Phase IIa study
Time frame: Before first dosing and at 12 months post cell transplantaion
Measured by SPECT with thallium-201 from baseline. The SRS, SSS and SDS are three variables used to measure cardiac perfusion and ischemia.
12 secondary outcomes
Time to the first occurrence of major adverse cardiovascular events (MACEs)
Time frame: 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
Time frame: Before first dosing and at 3, 6 months post cell transplantation
Change from baseline in echocardiographic measures.
Time frame: 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.
Time frame: Before first dosing, and 1, 3, 6 , 12 months post cell transplantation
Change in the 6-minute walk test (6-MWT) from baseline.
Time frame: Before first dosing and 6, 12 months post cell transplantation
Change in serum levels of amino-terminal pro-brain natriuretic peptide (NT pro-BNP) and high sensitivity cardiac troponin (hs-cTn) from baseline.
Time frame: Before first dosing, and 1, 3, 6 , 12 months post cell transplantation
Change in quality of life using the Seattle Angina Questionnaire (SAQ) from baseline.
Time frame: Before first dosing, and 1, 3, 6 , 12 months post cell transplantation
Change from baseline in echocardiographic measures.
Time frame: Before first dosing and at 3, 6, 12 months post cell transplantation
Change in the evaluation result of CCTA from baseline
Time frame: Before first dosing and at 3, 6 months post cell transplantation
Change in the evaluation result of CCTA from baseline
Time frame: Before first dosing and at 3, 6 months post cell transplantation
Change from baseline in echocardiographic measures.
Time frame: Before first dosing and at 3, 6, 12 months post cell transplantation.
Change from baseline in echocardiographic measures.
Time frame: Before first dosing and at 3, 6, 12 months post cell transplantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HeXell-2020 in people with Coronary Artery Disease, run by Hexun Biosciences Co., LTD. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Huang, Dr. (+88633175088 ext. 6888, simon.huang@hexunbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of TEAE, SAE and SUSAR over the study (time frame: Within the first year after cell transplantaion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.