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| Name | Class |
|---|---|
| TotipotentRX Corporation | UNKNOWN |
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The primary objective of the study is to determine the feasibility and safety of intracoronary administration of autologous bone marrow derived mononuclear cell product in patients at risk for clinically significant cardiac dysfunction following AMI.
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent placebo control patient group meeting eligibility but not receiving autologous bone marrow derived stem cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function.
Emerging evidence indicate that progenitor stem cells derived from bone marrow can be used to improve cardiac function in acute myocardial infarction patients. There is a great potential for stem cell therapy, using a variety of cell precursors to contribute to new blood vessel formation and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies. Across the globe AMI is the leading cause of morbidity and mortality. This cannot be prevented by optimal standard therapies i.e. balloon or stent dilation of the infarct vessels.
The study is a double blind, placebo controlled, randomized, multicenter trial. Male or female patients between 18-75 years with first incidence of Acute Myocardial Infarction(AMI) and LVEF less than or equal to 40% are included in the study. Patients who have undergone successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow are eligible to take part in the study.
A total of 30 subjects will be recruited and randomly assigned to receive concentrated BMMNC or placebo. All patients will undergo bone marrow aspiration within 3-10 days from the index event(infarction). Bone Marrow(BM) will be processed utilizing point of care technology. Following cell processing, the concentrated BMMNC or placebo control is infused directly into the infarct related artery using the stop flow method. Clinical follow up for all the subjects at 1,30, 60, 90, 180 and 360 days will be performed from the day of the procedure, with primary and secondary end points evaluated for both study arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Implantation of bone marrow derived mononuclear cells |
|
| Placebo Control | Placebo Comparator | Infusion of autologous peripheral blood |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Bone marrow mononuclear cells | Other | Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events as a measure of safety | Feasibility and safety of Intracoronary infusion of autologous BMMNCs processed through intraoperative point of care technology, freedom from arrhythmia's. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities. | Changes in the global Left Ventricular Ejection Fraction(LVEF), LV volumes-End Systolic Volume (ESV) and End Diastolic Volume (EDV), infarct size, myocardial mass, myocardial viability and regional wall motion abnormalities measured by Cardiac MRI and assessed by central Core lab. |
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Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Harris, MS | Contact | 13234207766 | ken.harris@totipotentrx.com | |
| Venkatesh Ponemone, PhD | Contact | 911244976860 | ponemone@totipotentrx.com |
| Name | Affiliation | Role |
|---|---|---|
| Venkatesh Ponemone, PhD | TotipotentRX Cell Therapy Pvt. Ltd. | Study Director |
| Kenneth Harris, MS | TotipotentRX Cell Therapy Pvt. Ltd. | Study Chair |
| Ashok Seth, FRCP, FACC |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CARE Hospitals, Banjara Hills | Hyderabad | Hyderabad | 500034 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21127322 | Result | Roncalli J, Mouquet F, Piot C, Trochu JN, Le Corvoisier P, Neuder Y, Le Tourneau T, Agostini D, Gaxotte V, Sportouch C, Galinier M, Crochet D, Teiger E, Richard MJ, Polge AS, Beregi JP, Manrique A, Carrie D, Susen S, Klein B, Parini A, Lamirault G, Croisille P, Rouard H, Bourin P, Nguyen JM, Delasalle B, Vanzetto G, Van Belle E, Lemarchand P. Intracoronary autologous mononucleated bone marrow cell infusion for acute myocardial infarction: results of the randomized multicenter BONAMI trial. Eur Heart J. 2011 Jul;32(14):1748-57. doi: 10.1093/eurheartj/ehq455. Epub 2010 Dec 2. | |
| 20576835 |
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|
| Placebo control | Other | Intracoronary infusion of autologous peripheral blood. |
|
|
| 12 Months |
| Major adverse cardiac events (MACE) | MACE was defined as the composites of any cause of death, myocardial infarction, revascularization of the target vessel, re-hospitalization for heart failure, and life-threatening arrhythmia. | 12 Months |
| Quality of life | Quality of life assessment is done using short-form 36, Minnesota living with heart failure questionnaire and Seattle Angina Questionnaire | 12 Months |
| Fortis Escorts Heart Institute and Research Centre |
| Principal Investigator |
| Upendra Kaul, MD,DM, FACC | Fortis Flt. Lt. Rajan Dhall Hospital | Principal Investigator |
| Sreenivas A Kumar, MD, DM, FACC | CARE Hospitals Hyderabad, India | Principal Investigator |
| Fortis Escorts Heart Institute and Research Centre | New Delhi | New Delhi | 110025 | India |
|
| Fortis Flt. Lt. Rajan Dhall Hospital | New Delhi | New Delhi | 110070 | India |
|
| Result |
| Strauer BE, Yousef M, Schannwell CM. The acute and long-term effects of intracoronary Stem cell Transplantation in 191 patients with chronic heARt failure: the STAR-heart study. Eur J Heart Fail. 2010 Jul;12(7):721-9. doi: 10.1093/eurjhf/hfq095. |
| 18598362 | Result | Dohmann HF, Silva SA, Sousa AL, Braga AM, Branco RV, Haddad AF, Oliveira MA, Moreira RC, Tuche FA, Peixoto CM, Tura BR, Borojevic R, Ribeiro JP, Nicolau JC, Nobrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study. Trials. 2008 Jul 3;9:41. doi: 10.1186/1745-6215-9-41. |