Long-term Follow-up Study Following the Approval of Hearticellgram-AMI Administration

February 6, 2026 updated by: Pharmicell Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To evaluate the safety for 60 months after a single dose of Hearticellgram-AMI in patients with Acute Myocardial Infarction.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
    • Gangnam
      • Seoul, Gangnam, South Korea, 06017
        • Recruiting
        • KIMHYUNSOO Clinic
        • Contact:
          • HYUNSOO KIM
          • Phone Number: 82-2-511-1101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Those who had administered Hearticellgram-AMI
  2. Those who voluntarily agreed in writing to participate in this investigation

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hearticellgram-AMI
Patients with Acute Myocardial Infarction who had administered Hearticellgram-AMI.
Biological: Hearticellgram-AMI
Patients who had administered Hearticellgram-AMI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of AESI
Time Frame: For 5 years
death, neoplasms or malignancies in tissues or organs, Immune response
For 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmicell Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2022

Primary Completion (Estimated)

October 12, 2028

Study Completion (Estimated)

September 30, 2032

Study Registration Dates

First Submitted

May 9, 2024

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PMC-P-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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