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

Acute Myocardial Infarction Clinical Trial

— AMIRST  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01536106
• Other study ID #: TPRX/POC/BMSC/AMIRST/1.0
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: July 16, 2011
• Last updated: September 3, 2013
• Start date: December 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2013
• Source: TotipotentRX Cell Therapy Pvt. Ltd.
• Contact: Kenneth Harris, MS
• Phone: 13234207766
• Email: ken.harris[@]totipotentrx.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Other:
• Autologous Bone marrow mononuclear cells
Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.
• Placebo control
Intracoronary infusion of autologous peripheral blood.

Locations

Country	Name	City	State
India	CARE Hospitals, Banjara Hills	Hyderabad
India	Fortis Escorts Heart Institute and Research Centre	New Delhi
India	Fortis Flt. Lt. Rajan Dhall Hospital	New Delhi

Sponsors (2)

Lead Sponsor	Collaborator
TotipotentRX Cell Therapy Pvt. Ltd.	TotipotentRX Corporation

Country where clinical trial is conducted

India, 

References & Publications (3)

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, Nóbrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell — View Citation

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, Croisi — View Citation

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. Erratum i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	12 Months	No
Secondary	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	Yes
Secondary	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	No