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

This study is not yet open for participant recruitment.
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

July 16, 2011
September 3, 2013
December 2013
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01536106 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Rapid Delivery of Autologous Bone Marrow Derived Stem Cells in Acute Myocardial Infarction Patients.
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)

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • 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
  • Other: Placebo control
    Intracoronary infusion of autologous peripheral blood.
    Other Name: Placebo control group
  • Experimental: Treatment
    Implantation of bone marrow derived mononuclear cells
    Intervention: Other: Autologous Bone marrow mononuclear cells
  • Placebo Comparator: Placebo Control
    Infusion of autologous peripheral blood
    Intervention: Other: Placebo control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
30
March 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact: Kenneth Harris, MS 13234207766 ken.harris@totipotentrx.com
Contact: Venkatesh Ponemone, PhD 911244976860 ponemone@totipotentrx.com
India
 
NCT01536106
TPRX/POC/BMSC/AMIRST/1.0
Yes
TotipotentRX Cell Therapy Pvt. Ltd.
TotipotentRX Cell Therapy Pvt. Ltd.
TotipotentRX Corporation
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
TotipotentRX Cell Therapy Pvt. Ltd.
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP