NCT07400458

Brief Summary

This Long-term follow-up is designed to evaluate the safety of patient with Acute Myocardial Infarction who had administered Hearticellgram-AMI.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
78mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Mar 2022Sep 2032

Study Start

First participant enrolled

March 3, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2024

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2028

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2032

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

6.6 years

First QC Date

May 9, 2024

Last Update Submit

February 6, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of AESI

    death, neoplasms or malignancies in tissues or organs, Immune response

    For 5 years

Study Arms (1)

Hearticellgram-AMI

EXPERIMENTAL

Patients with Acute Myocardial Infarction who had administered Hearticellgram-AMI.

Biological: Hearticellgram-AMI

Interventions

Patients who had administered Hearticellgram-AMI.

Hearticellgram-AMI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Those who had administered Hearticellgram-AMI
  • Those who voluntarily agreed in writing to participate in this investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KIMHYUNSOO Clinic

Seoul, Gangnam, 06017, South Korea

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2024

First Posted

February 10, 2026

Study Start

March 3, 2022

Primary Completion (Estimated)

October 12, 2028

Study Completion (Estimated)

September 30, 2032

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations