Safety Study of Clinical Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pharmicell Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01595113

First received: May 8, 2012

Last updated: November 13, 2013

Last verified: November 2013

History of Changes

Purpose

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.

Condition
Acute Myocardial Infarction


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Retrospective
Official Title:	A Follow-up Observational Study of Safety of Clinical Trial Conducted With Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Pharmicell Co., Ltd.:


Estimated Enrollment:	40
Study Start Date:	May 2012
Study Completion Date:	December 2012
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects agreed to participate in this follow-up observational study among the subjects (80 patients:40-test group, 40-control group) who participated in the previously conducted clinical trial.

Criteria

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:

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01595113 History of Changes
Other Study ID Numbers:	PMC-BD-CT-P-001
Study First Received:	May 8, 2012
Last Updated:	November 13, 2013
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:


Infarction Myocardial Infarction Cardiovascular Diseases Heart Diseases Ischemia	Myocardial Ischemia Necrosis Pathologic Processes Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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