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

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: Acute Myocardial Infarction
• Intervention / Treatment: Biological: 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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: daeun jung; Phone Number: 82-2-3496-0134; Email: daeun4100@pharmicell.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	death, neoplasms or malignancies in tissues or organs, Immune response	For 5 years

Collaborators and Investigators

• Sponsor: Pharmicell Co., Ltd.

Study record dates

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