Long-term follow-up after Hearticellgram-AMI treatment
Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration to Evaluate Its Safety in Patients With Acute Myocardial Infarction
We will follow people who got one dose of Hearticellgram-AMI after a heart attack for up to 60 months to see if the treatment stays safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Pharmicell Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Gangnam) |
| Trial ID | NCT07400458 on ClinicalTrials.gov |
What this trial studies
This is a long-term safety follow-up of patients with acute myocardial infarction who previously received a single administration of Hearticellgram-AMI. Participants will be monitored for 60 months with periodic clinic visits and medical record reviews to capture adverse events and clinical outcomes. Enrollment is limited to individuals who already received the product and who provide written informed consent. The follow-up is conducted at a single clinical site in Seoul to document long-term safety signals after approval.
Who should consider this trial
Good fit: Ideal candidates are people who previously received Hearticellgram-AMI after an acute myocardial infarction and who agree to attend long-term follow-up visits.
Not a fit: Patients who never received Hearticellgram-AMI or who need new active treatments for heart disease will not receive direct therapeutic benefit from this follow-up.
Why it matters
Potential benefit: If successful, the follow-up could provide patients and clinicians with evidence that a single dose of Hearticellgram-AMI remains safe over the long term.
How similar studies have performed: Other cell-therapy programs for acute myocardial infarction have produced mixed short-term results and limited long-term safety data, so extended follow-up like this is common but not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Those who had administered Hearticellgram-AMI 2. Those who voluntarily agreed in writing to participate in this investigation Exclusion Criteria: \-
Where this trial is running
Seoul, Gangnam
- KIMHYUNSOO Clinic — Seoul, Gangnam, South Korea (Recruiting)
Study contacts
- Study coordinator: Daeun Jung
- Email: daeun4100@pharmicell.com
- Phone: 82-2-3496-0134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.