Safety Study of Clinical Cell Transplant Therapy Using Hearticellgram-AMI for Patients With Acute Myocardial Infarction
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ClinicalTrials.gov Identifier: NCT01595113 |
Recruitment Status
:
Completed
First Posted
: May 9, 2012
Last Update Posted
: November 15, 2013
|
Sponsor:
Pharmicell Co., Ltd.
Information provided by (Responsible Party):
Pharmicell Co., Ltd.
- Study Details
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- No Results Posted
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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 |
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 Type : | Observational |
Estimated Enrollment : | 40 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
U.S. FDA Resources
Information from the National Library of Medicine

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
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:
No Contacts or Locations Provided
Responsible Party: | Pharmicell Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT01595113 History of Changes |
Other Study ID Numbers: |
PMC-BD-CT-P-001 |
First Posted: | May 9, 2012 Key Record Dates |
Last Update Posted: | November 15, 2013 |
Last Verified: | November 2013 |
Additional relevant MeSH terms:
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |