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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01595113
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmicell Co., Ltd.

Study Description
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Brief 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.

Condition or disease
Acute Myocardial Infarction

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.
Study Design
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Study Type : Observational
Actual Enrollment : 41 participants
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
Study Start Date : May 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

  • N/A
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595113


Sponsors and Collaborators
Pharmicell Co., Ltd.
Investigators
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Principal Investigator: Min-Soo Ahn Wonju Severance Christian Hospital
More Information
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Responsible Party: Pharmicell Co., Ltd.
ClinicalTrials.gov Identifier: NCT01595113    
Other Study ID Numbers: PMC-BD-CT-P-001
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: November 2013
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases