Rapid Delivery of Autologous Bone Marrow Derived Stem Cells in Acute Myocardial Infarction Patients. (AMIRST)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by TotipotentRX Cell Therapy Pvt. Ltd.
Sponsor:
Collaborator:
TotipotentRX Corporation
Information provided by (Responsible Party):
TotipotentRX Cell Therapy Pvt. Ltd.
ClinicalTrials.gov Identifier:
NCT01536106
First received: July 16, 2011
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Other: Autologous Bone marrow mononuclear cells
Other: Placebo control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intracoronary Infusion of Concentrated Autologous Bone Marrow Mononuclear Cells in Acute Myocardial Infarction Patients Utilizing a Novel Point-of-Care Device for Rapid-Delivery of Stem Cells (AMIRST)

Resource links provided by NLM:


Further study details as provided by TotipotentRX Cell Therapy Pvt. Ltd.:

Primary Outcome Measures:
  • Number of adverse events as a measure of safety [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    Feasibility and safety of Intracoronary infusion of autologous BMMNCs processed through intraoperative point of care technology, freedom from arrhythmia's.


Secondary Outcome Measures:
  • 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. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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.

  • Major adverse cardiac events (MACE) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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.

  • Quality of life [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Quality of life assessment is done using short-form 36, Minnesota living with heart failure questionnaire and Seattle Angina Questionnaire


Estimated Enrollment: 30
Study Start Date: December 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Implantation of bone marrow derived mononuclear cells
Other: Autologous Bone marrow mononuclear cells
Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.
Other Name: BMMNC treatment group
Placebo Comparator: Placebo Control
Infusion of autologous peripheral blood
Other: Placebo control
Intracoronary infusion of autologous peripheral blood.
Other Name: Placebo control group

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or Female of age 18 - 75 years
  • Incidence of first myocardial infarction
  • Acute STEMI with LV hypokinesia involving anteroseptal, lateral or inferior walls
  • LVEF < 40% pre-intervention
  • Successful percutaneous intervention (PCI) within ≤ 24 hours after onset of symptoms (PTCA/stent) or / and Thrombolysed patients having TIMI-3 flow.
  • Written informed consent

Exclusion Criteria:

  • Multi-vessel coronary disease requiring surgical intervention (CABG) or left main coronary artery disease > 50% blockage
  • Previous history of CABG
  • Pulmonary edema
  • Cardiogenic shock
  • Myocarditis
  • Renal or hepatic dysfunction
  • Hematologic disease

General Exclusion Criteria:

  • Alcohol or drug dependency, active or uncontrolled acute myocarditis
  • HIV, HBV, or HCV infections
  • Evidence of malignant or hematological diseases
  • Metal implants of any kind
  • Claustrophobia
  • Renal insufficiency
  • History of bleeding disorder
  • Anemia (haemoglobin <8.5mg/dl)
  • Platelet count <100,000/ml
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536106

Contacts
Contact: Kenneth Harris, MS 13234207766 ken.harris@totipotentrx.com
Contact: Venkatesh Ponemone, PhD 911244976860 ponemone@totipotentrx.com

Locations
India
CARE Hospitals, Banjara Hills Not yet recruiting
Hyderabad, India, 500034
Contact: Sreenivas A Kumar    040-30418126    arramraj@yahoo.com   
Principal Investigator: Sreenivas A Kumar, MD, DM, FACC         
Sub-Investigator: Venkatesh Ponemone, PhD         
Fortis Escorts Heart Institute and Research Centre Not yet recruiting
New Delhi, India, 110025
Contact: Ashok Seth, FRCS, FSCAI    911147134232    ashok.seth@fortishealthcare.com   
Contact: Vinay Sanghi, MD    911147135000    vinay.sanghi@fortishealthcare.com   
Principal Investigator: Ashok Seth, FRCS, FSCAI         
Sub-Investigator: Upendra Kaul, MD, DM, FACC         
Sub-Investigator: Vishal Rastogi, MD, DM         
Sub-Investigator: Vinay Sanghi, FACP,FACC         
Sub-Investigator: Mona Bhatia, MD         
Sub-Investigator: Venkatesh Ponemone, PhD         
Fortis Flt. Lt. Rajan Dhall Hospital Not yet recruiting
New Delhi, India, 110070
Contact: Upendra Kaul, MD    911147135000    upendra.kaul@fortishealthcare.com   
Contact: Tapan Ghose, MD    911147134232    tapan.ghose@fortishealthcare.com   
Principal Investigator: Upendra Kaul, MD, DM, FACC         
Sub-Investigator: Tapan Ghose, MD         
Sub-Investigator: Ripen Gupta, MD         
Sub-Investigator: Ranjan Kachru, MD         
Sub-Investigator: Mona Bhatia, MD         
Sub-Investigator: Venkatesh Ponemone, PhD         
Sponsors and Collaborators
TotipotentRX Cell Therapy Pvt. Ltd.
TotipotentRX Corporation
Investigators
Study Director: Venkatesh Ponemone, PhD TotipotentRX Cell Therapy Pvt. Ltd.
Study Chair: Kenneth Harris, MS TotipotentRX Cell Therapy Pvt. Ltd.
Principal Investigator: Ashok Seth, FRCP, FACC 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
  More Information

Publications:
Responsible Party: TotipotentRX Cell Therapy Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT01536106     History of Changes
Other Study ID Numbers: TPRX/POC/BMSC/AMIRST/1.0
Study First Received: July 16, 2011
Last Updated: September 3, 2013
Health Authority: India: Indian Council of Medical Research

Keywords provided by TotipotentRX Cell Therapy Pvt. Ltd.:
Cell therapy, Bone marrow stem cells, cardiac cell therapy

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014