Long-term Follow-up Study Following the Approval of Heart... | NCT07400458

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

NCT07400458

Sponsor

Pharmicell Co., Ltd.

Status

Recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Acute Myocardial Infarction

Interventions

Hearticellgram-AMI

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2022Actual

Primary Completion Date

Oct 12, 2028Estimated

Completion Date

Sep 30, 2032Estimated

First Submitted Date

May 9, 2024

First Submission Date that Met QC Criteria

Feb 6, 2026

First Posted Date

Feb 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hearticellgram-AMI	Experimental	Patients with Acute Myocardial Infarction who had administered Hearticellgram-AMI.	Biological: Hearticellgram-AMI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hearticellgram-AMI	Biological	Patients who had administered Hearticellgram-AMI.	Hearticellgram-AMI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DAEUN JUNG	Contact	82-2-3496-0134		daeun4100@pharmicell.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KIMHYUNSOO Clinic	Recruiting	Seoul	Gangnam	06017	South Korea