Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Stempeutics Research Pvt Ltd |
---|---|
Information provided by: | Stempeutics Research Pvt Ltd |
ClinicalTrials.gov Identifier: | NCT00883727 |
This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.
Condition | Intervention | Phase |
---|---|---|
Myocardial Infarction |
Drug: Stem cell Drug: Plasmalyte A |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase - i/ii Study Assessing the Safety and Efficacy of Intravenous ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells in Patients With st Elevated Acute Myocardial Infarction (Stemi) |
Estimated Enrollment: | 20 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
stem cells: Experimental |
Drug: Stem cell
IV infusion of stem cells
|
Placebo: Placebo Comparator |
Drug: Plasmalyte A
IV infusion
|
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Radhika C Radhakrishnan, MD | 918025024611 | radhika.cr@stempeutics.com |
Contact: Pawan K Gupta, PhD | 918025024611 | pawan.kumarg@manipal.edu |
India, Andhra Pradesh | |
Care Hospital | Recruiting |
Hyderabad, Andhra Pradesh, India, 500034 | |
Principal Investigator: Sreenivas Kumar, MD, DM | |
India, Gujarat | |
SAL Hospital and Medical Institute | Not yet recruiting |
Ahmedabad, Gujarat, India, 380054 | |
Principal Investigator: Satya Gupta, MD, DM | |
India, Karnataka | |
Bhagawan Mahaveer Jain Heart Centre | Recruiting |
Bangalore, Karnataka, India, 5660052 | |
Principal Investigator: R Keshava, MD, DM |
Principal Investigator: | Sreenivas Kumar, MD, DM | Care Hospital, Hyderabad |
Principal Investigator: | Satya Gupta | SAL Hospital, Ahmedabad |
Principal Investigator: | R Keshava, MD, DM | Bhagwan Mahaveer JAin Hospital, Bangalore |
Responsible Party: | Stempeutics Research Private Limited ( President ) |
Study ID Numbers: | SRPL/AMI/07-08/001 |
Study First Received: | April 17, 2009 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00883727 History of Changes |
Health Authority: | India: Drugs Controller General of India |
mesenchymal stem cells myocardial infarction |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction |
Necrosis Heart Diseases Pathologic Processes Myocardial Ischemia Vascular Diseases |
Cardiovascular Diseases Ischemia Infarction Myocardial Infarction |