ACUTE MYOCARDIAL INFARCTION
Cardiovascular disease (“CVD”) is the number one cause of morbidity and mortality worldwide. An estimated 17.3 million people died from CVDs in 2008, representing 30% of all global deaths. Of these deaths 7.3 million were due to coronary heart disease and 6.2 million from stroke. In the progression of CVDs, plaque lesions develop in arteries that result in a narrowing of vessels, and in severe cases the vulnerable plaque breaks open and creates a blockage of blood flow to vital organs in the heart or brain. In the case of the heart, when this plaque rupture happens blocking blood flow to certain regions of the heart it is classified as a myocardial infarction.
Left ventricular ejection fraction (LVEF), the volume of blood pumped out of the left ventricle, is one of the key indications of mortality rates post myocardial infarction. A reduced LVEF is one of the risk factors for both sudden and non-sudden death, with the odds ratio for 1 year mortality after myocardial infarction at 9.48 (High Rate) for patients with an LVEF of 30% compared to patients with LVEF > 50%, 2.94% (Moderate Rate) for patients with LVEF 30-40%, whereas the risk is not significantly increased (low rate) in patients with LVEF 40-50%. We are focused on developing a cellular therapeutic for the LVEF High Rate risk ST-Elevated Myocardial Infarction patient using the patient’s own bone marrow derived stem cells. Our integrated SurgWerks-AMI technology is designed as comprehensive device kit having all the necessary devices optimized to harvest, process, quality control and deliver the autologous Bone Marrow Concentrate enriched Progenitor Cell into the intracoronary artery in 60-90 minutes.
- More than 11 Phase I and II academic clinical studies have been completed to date using autologous bone marrow derived stem cells on AMI patients (1)
- Low LVEF patients progress to heart failure and death at three times the rate in the first year as patients whose LVEF returns to normal after an AMI
- Approximately 5 million people in the USA are affected by heart failure, with 60% from ischemic heart disease(2)
- It is estimated that 720,000 people in the USA have an AMI each year and 124,000 in the U.K. and the incidence of ST-Elevated Myocardial Infarctions (STEMI) is 77 per 100,000 total inhabitants. (3)
- A severely depressed LVEF early after a STEMI is present in 10% of all patients (4)
We reported Pilot( Early Feasibility ) study results in October 2013. In this open label single arm study, a single no-option STEMI patient was enrolled with an LVEF of 35% three days after emergency room admission and implantation of a coronary stent. The patient was treated with our SurgWerks-AMI process on Day 6 after stent placement. The patient ended the study having experienced no Major Adverse Cardiovascular Events (Safety) with an LVEF of 60.3%.
Next Development Steps
In the summer of 2014, we are submitting the Phase Ib/II Feasibility study plan to the Indian authorities, and to discuss the next steps in clinical development.
(1) Behfar A., et al: Cell therapy for cardiac repair – lessons from clinical trials. Nat. Rev. Cardiol. doi:10.1038/nrcardio.2014.9
(2) Wilensky R., et al: Intracoronary delivery of bone-marrow-derived stem cells. Stem Cell Research and Therapy 2010, 1:29
(3) Goldberg R., et al: Recent Trends in the Incidence, Treatment, and Outcomes of Patients with STEMI and NSTEMI. doi:10.1016/j.amjmed.2010.07.023
(4) Sticherling C., et al; Prevalence of severely impaired left ventricular ejection fraction after reperfused ST-elevation myocardial infarction. Swiss Med Weekly. Sep 6; 143:w13869. doi: 10.4414/smw.2013.13869