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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01595113
Other study ID # PMC-BD-CT-P-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2012
Est. completion date December 2012

Study information

Verified date November 2013
Source Pharmicell Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety of the previously conducted clinical trial cell transplant therapy using Hearticellgram-AMI for patients with acute myocardial infarction. This is a follow-up observational study and targeting the subjects who participated in the previously conducted clinical trial.


Description:

The safety evaluation in this clinical trial is performed with variables, such as occurrence and severity of adverse events, clinical laboratory tests, vital signs, physical examination, cardiac events, and cancer.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date December 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients who have elapsed for more than 2 years after onset of acute myocardial infarction among the patients who had received cell transplant therapy or drug treatment at least once in test and control group on the previously conducted clinical trial.

- Subjects agreed to participate in this follow-up study and signed the consent form.

Exclusion Criteria:

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pharmicell Co., Ltd.
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