Acute Myocardial InfarctionNCT07400458
Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration
A study testing Hearticellgram-AMI in people with Acute Myocardial Infarction, run by Pharmicell Co., Ltd. at 1 site in South Korea.
Trial summary
This Long-term follow-up is designed to evaluate the safety of patient with Acute Myocardial Infarction who had administered Hearticellgram-AMI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Hearticellgram-AMI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Mar 2022to 30 Sep 2032
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Those who had administered Hearticellgram-AMI
- Those who voluntarily agreed in writing to participate in this investigation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
KIMHYUNSOO Clinic
Seoul, Gangnam, 06017
HYUNSOO KIM, 82-2-511-1101
About this study
Official title: Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration to Evaluate Its Safety in Patients With Acute Myocardial Infarction
This Long-term follow-up is designed to evaluate the safety of patient with Acute Myocardial Infarction who had administered Hearticellgram-AMI.
Read the detailed description
To evaluate the safety for 60 months after a single dose of Hearticellgram-AMI in patients with Acute Myocardial Infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Hearticellgram-AMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearticellgram-AMIBiological
Patients who had administered Hearticellgram-AMI.
| Study group | Role | What they receive |
|---|---|---|
| Hearticellgram-AMI | Experimental | Patients with Acute Myocardial Infarction who had administered Hearticellgram-AMI. Receives: Biological: Hearticellgram-AMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of AESI
death, neoplasms or malignancies in tissues or organs, Immune response
Measured: For 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start3 Mar 2022
- Primary completion12 Oct 2028 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmicell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400458
- Sponsor's protocol ID
- PMC-P-13
- Status last verified
- Feb 2026
- First submitted
- 9 May 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration to Evaluate Its Safety in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT07400458
- Acronym / sponsor ID
- PMC-P-13
- Conditions
- Acute Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pharmicell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 12 Oct 2028 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 10 Feb 2026 (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 Long-term follow-up is designed to evaluate the safety of patient with Acute Myocardial Infarction who had administered Hearticellgram-AMI.
Detailed description
To evaluate the safety for 60 months after a single dose of Hearticellgram-AMI in patients with Acute Myocardial Infarction.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearticellgram-AMI | Experimental | Biological: Hearticellgram-AMIPatients with Acute Myocardial Infarction who had administered Hearticellgram-AMI. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Those who had administered Hearticellgram-AMI
- Those who voluntarily agreed in writing to participate in this investigation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Hearticellgram-AMIPatients who had administered Hearticellgram-AMI. | Biological | Hearticellgram-AMI |
Primary outcome
Rate of AESI
Time frame: For 5 years
death, neoplasms or malignancies in tissues or organs, Immune response
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 10 Feb 2026.
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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 study testing Hearticellgram-AMI in people with Acute Myocardial Infarction, run by Pharmicell Co., Ltd. at 1 site in South Korea.
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 2 inclusion and 1 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 10 Feb 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 South Korea. 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.
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 DAEUN JUNG (82-2-3496-0134, daeun4100@pharmicell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of AESI (time frame: For 5 years). 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 10 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.