Phase 2 study for people with Heart Disease

Not yet recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Not yet recruiting
Phase Phase 2
Sponsor HONYA Medical Co Ltd
Registry number NCT07134712
Started 30 March 2026 Today 16 October 2026 Estimated completion 31 December 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Flinders Medical Centre Bedford Park SA Status not stated

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 45 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 102

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

1. Age ≥ 45 years, BMI ≤ 32

2. Patients diagnosed with acute myocardial infarction by a cardiologist, within 36 hours to 7 days post-diagnosis, and able to complete cell infusion within this period.

3. Left ventricular ejection fraction (LVEF) ≤ 45%, hemodynamically stable patients who do not require vasopressor support within 24 hours.

4. Patients with a history of coronary artery disease, who have previously undergone percutaneous coronary intervention or coronary artery bypass graft surgery, may also be included upon evaluation by a cardiologist.

5. Patients deemed unsuitable for percutaneous coronary intervention or coronary artery bypass graft surgery by a cardiologist.

6. Must agree to sign the informed consent form.

7. Subjects must use effective contraception during the study observation period and for 6 months after its conclusion to ensure no pregnancy occurs during the study. (Primarily for women of childbearing potential).

8. Agree to and comply with the required outpatient visits and examinations during the study observation period.

Exclusion Criteria:

1. Age \< 45 years, BMI \> 32.

2. Women who are planning to become pregnant, are pregnant, or are breastfeeding

3. Immunodeficiency diseases caused by infection , such as Human Immunodeficiency Virus (HIV).

4. Patients diagnosed as needing coronary artery bypass surgery or potentially requiring coronary revascularization surgery within the next 6 months.

5. Severe aortic or mitral valve stenosis.

6. Life-threatening arrhythmias.

7. Malignant tumors, including all categories and cancer conditions.

8. Hematologic disorders or other severe organ diseases with an expected survival of less than one year.

9. Chronic kidney disease (eGFR \< 30 mL/min/1.73m²) or patients undergoing dialysis.

10. Patients with autoimmune diseases or those who have already received immunotherapy.

11. Patients who have undergone tumor treatment or require immunosuppressive therapy within the last three years.

12. History of transfusion reactions.

13. Recipients of bone marrow or organ transplants.

14. Liver dysfunction (bilirubin \> 2.5 mg/dL or transaminases \> 5x the upper limit of normal).

15. Patients who have previously received growth factors, cytokines, gene therapy, or stem cell therapy.

16. Subjects participating in more than one clinical trial.

17. Inability to sign the consent form or comply with outpatient follow-up after infusion therapy.

18. Patients with a known allergy to this product or its excipients (e.g., dimethyl sulfoxide, cell preservation solution).

Dates on the record

Started 30 March 2026
Estimated completion 31 December 2027
Registry last updated 11 March 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 11 March 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.