Cesca Therapeutics Earns IEC Approval for Surgwerks Trial

Rancho Cordova, Calif.-based Cesca Therapeutics Inc., an autologous cell-based regenerative medicine company, has received Institutional Ethics Committee (IEC) approval to initiate the Surgwerks-AMI and VXP system (patent pending) phase II clinical trial. The company’s Surgwerks platform is an integrated protocol, disposable devices and equipment product for rapid intra-operative use in 60-90 minutes. Approval for this trial paves the way for the safety and preliminary 6 month efficacy study of 40 patients having suffered an ST-elevated myocardial infarction (STEMI) resulting in a left ventricle ejection fraction (LVEF) of less than or equal to 40 percent at least 72 hours after a primary acute myocardial infarction (AMI). The study will be a 1:1 randomized, open label, active controlled, multi-center device Phase II (feasibility) trial.

The study follows a successful 24 month single patient pilot trial of a primary STEMI 43 year old male who had an LVEF of 35 percent on admission to the emergency department, was unresponsive to reperfusion and pharmaceutical therapies and underwent treatment with Cesca’s AMIRST I therapy six days after the primary heart attack. As reported in the case report publication in 2013, at the 24 month follow-up the patient had a normal LVEF of 60.3 percent, suffered no complications, and was doing remarkably well.

This new clinical trial, titled AMIRST II, will test the company’s point-of-care medical device treatment on a larger patient population for safety and efficacy. Essentially, individuals who suffer a primary heart attack and are adequately re-perfused by stenting or clot busting drugs but fail to recover with a healthy heart pumping action will be candidates for this experimental therapy. The procedure takes 90 minutes, involves a single trip to the heart catheterization lab, and uses a specially optimized system of devices for aspirating bone marrow, preparing the cell formulation with the bedside “smart-vision”-based VXP system, and injecting the cells through the coronary artery with a specialized cell therapy catheter.

“We are pleased to take the next step in the development of the Surgwerks-AMI and VXP system technology specific to this patient population who have a poor prognosis without regenerative medicine,” said Ken Harris, president of Cesca. “We estimate that more than 30,000 patients would fit our stringent inclusion criteria in the United States alone, and that such a therapy will have an annual global market between $750M to $1B. Our patent pending method, and patented devices bring a scaled down version of the biopharmaceutical plant directly into real-time bedside medicine, empowering the interventional cardiologist to ensure the cells are fresh, safe, viable and potent.”

The company will conduct this phase II study in India, and if meeting the safety endpoints, will plan for pivotal efficacy trials in the United States, European Union and India in late 2017. Under the new Indian clinical trial authorization procedure, a three-step approval process is followed. First, a nationally recognized and registered Institutional Ethics Committee must review and approve the trial, followed by an Expert Advisory Committee, which will make final recommendations to a Technical Review Committee (TRC) of the Central Drugs Standard Control Organization. The TRC will have the final decision in granting approval for the trial. This entire process is expected to take up to six additional months, and will be spearheaded by the company’s clinical and regulatory departments with support by National Principle Investigator Ashok Seth, M.D., F.R.C.P., chairman of Cardiovascular Medicine at Fortis Healthcare.