Stem Cell Trials Show Sustained Heart Function Improvement
December 04, 2017
Australian adult stem cell company, Mesoblast Limited, today announced positive
initial results of clinical adult stem cell trials for the treatment of
heart disease being conducted in conjunction with its United States-based
sister company Angioblast Systems Inc.
Angioblast and Mesoblast are conducting a Pilot Clinical Trial in Australia focused upon the treatment of up to 10 patients suffering from severe coronary artery disease and heart muscle damage. Cells used in this trial are autologous, or the patients' own cells, which have been selected and cultured using the company's proprietary technology.
"Interim results from our clinical trial at the John Hunter Hospital in Australia have shown that heart function has improved in each of the patients treated so far," Mesoblast Chief Scientific Adviser, Professor Silviu Itescu, said.
In up to six months of follow-up after the patients' cells were implanted into their damaged heart muscle, each of the first three patients treated had demonstrated improvement in global heart function of 20-60% relative to baseline, as determined by serial echocardiograms.
"This degree of improvement in heart function in these very ill patients is extremely encouraging, and we look forward to completing the trial and reporting on the outcomes of all the patients in due course," Principal Investigator at the John Hunter Hospital, interventional cardiologist Dr Suku Thambar, said.
Preclinical Trial Using 'Off-The-Shelf' Cells Support Clinical Trial Results:
The company has also now completed a number of large animal studies focused upon the use of allogeneic stem cells, or cells from an unrelated donor, for repair of damaged heart muscle and improvement of heart function after a myocardial infarct, or heart attack. In these studies the company's proprietary stem cells, obtained from an allogeneic donor, were expanded and frozen post GMP compliant manufacturing, in effect, an 'off-the-shelf' stem cell product. All studies were undertaken by specialist organizations and results have been independently reviewed.
"Our clinical trial experience has been further supported by results from a number of large animal studies we have just completed using allogeneic stem cells to improve heart function after a heart attack.
"In these studies, heart function in stem cell treated animals was significantly superior to control groups that did not receive stem cells, confirming the safety and effectiveness of our frozen, pre-cultured allogeneic stem cells," Professor Itescu said.
In one study performed at the University of Pennsylvania, 36 sheep underwent coronary artery occlusion and were treated with either the company's stem cells obtained from an unrelated donor or placebo. On the trial's completion at two months, the animals treated with the allogeneic stem cells demonstrated up to 50% greater mean global heart function than those receiving placebo, as determined by serial echocardiograms.
Importantly, pathology studies have not shown evidence of allergic reaction, rejection, or abnormal tissue formation.
"These are major steps forward in proving the company's primary business model to develop an off-the-shelf cell therapy product for improving heart function," Professor Itescu added.
About Mesoblast Limited:
Mesoblast Limited (ASX:MSB/OTC:MBLTY) is an Australian biotechnology company committed to commercialisation of novel treatments for orthopedic conditions, including a unique adult stem cell technology aimed at the regeneration and repair of bone and cartilage. Mesoblast has worldwide exclusive rights to a series of patents and technologies that have been developed over more than 10 years relating to the identification, extraction and culture of adult Mesenchymal Precursor Cells (MPCs). The company has also acquired a 33.3% interest in Angioblast Systems Inc, an American company developing the platform MPC technology for the treatment of cardiovascular diseases, including repair and regeneration of blood vessels and heart muscle. Mesoblast's strategy is to maximize shareholder value through both corporate partnerships and rapid product commercialization.