The medical and health care industries can be difficult marketplaces due to the high level of competition, however when a company is head and shoulders above the rest, the payoff can be incredible for all of the investors who bought in at the right time. And it looks like right now could be that time for Bioheart.
Bioheart, Inc. (Nasdaq: BHRT, click here for a company profile) is a company that is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient’s quality of life and reduce health care costs and hospitalizations. Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage.
And this past week was very exciting for Bioheart who announced that a preclinical study involving the injection of adipose-derived stem cells (ADSCs) into the myocardium (heart muscle tissue) of infarcted rats, was recently completed at the Jordan University of Science and Technology in Irbid, Jordan by medical and veterinary doctors from that institution and the University of Jordan in Amman, Jordan.
The study, led by Mahmoud Abu-Abeeleh, MD, Assistant Professor of Cardiac Surgery, University of Jordan School of Medicine, Amman-Jordan, showed evidence of regeneration of cardiomyocytes (heart cells) subsequent to injection of ADSCs following heart attack, or acute myocardial infarction (AMI). The study consisted of 99 nude rats* randomized into one of six treatment arms (including a control group receiving injection-vehicle containing cell media only). ADSCs for the treatment groups were obtained from humans using the TGI 100 Cell Isolation System for collection of endothelial progenitor cells (bone-marrow derived cells) and stem cells from adipose (fat) tissue. Bioheart has secured an exclusive, worldwide license to, upon commercial approval, sell or lease the more advanced TGI 1200 System, manufactured by Tissue Genesis, Inc. for the treatment of AMI.
“We are very proud of our pre-clinical work with adipose-derived stem cells,” said Howard J. Leonhardt, Bioheart CEO and Chief Technology Officer. “We hope that this and other pre-clinical studies will allow us to obtain IND approval for the start of a human clinical trial involving these cells for use in patients soon after they have a heart attack.”
Upon histological analysis, the control group animals showed a tendency toward granular tissue formation (scar formation), active phagocytosis (removal of pathogens or dead cells), variable angiogenesis (new blood vessel formation) when evaluated at 10 days, early fibrosis (fibrous connective tissue formation) when evaluated at 30 days and, in some cases, established fibrosis when evaluated at 60 days. The treatment arms, however, showed a tendency toward cardiomyocyte regeneration, prominent angiogenesis (growth of new blood vessels) when evaluated at 10 days, and reduction in the infarction size when evaluated at 60 days. In some of the treated animals, minimal scarring area was observed when compared to the control group, with as much as a 90 percent reduction in myocardial scar size versus the average scar size of the control group.
*Nude rats lack an immune system, which allows for the use of human cells in preclinical studies.
These results are indicative of cardiomyocyte regeneration and suggest that the injection of ADSCs after AMI may have the potential to help the infarcted heart return to normal function.
Stem Cells
“The study data suggest that injection of adipose-derived stem cells decreased the amount of damage from myocardial infarction by assisting in the formation of functional myocardial cells,” said Dr. Abu-Abeeleh. “This is a significant and encouraging finding, which adds to the growing body of investigational evidence of using adipose-derived stem cells in the treatment of heart attacks and warrants further study of Bioheart’s Acute Cell Therapy.”
Fat tissue is an abundant and readily available source of endothelial progenitor and adult stem cells and is easily extractable from a patient using mildly invasive techniques.
The advanced TGI 1200 System is a compact, fully automated cell isolation system for the rapid processing of patient-derived fat tissue to separate, isolate and produce large yields of endothelial progenitor cells and stem cells. Tissue Genesis, Inc., is currently seeking certification to apply the CE Mark for commercial sale and distribution of the TGI 1200 as a tissue processing system within the European Union. The study, sponsored by Bioheart, Inc., was organized by the Philadelphia BioMed Product Development Centre, an indirect wholly owned subsidiary affiliated with a member of Bioheart’s Board of Directors. Study objectives included assessment of the distribution and phenotype of the transplanted ADSCs and complete macroscopic exam and histopathology of selected tissues in a total of six differentiated study groups of approximately 15 subjects each.
A proposed pathway for seeking regulatory approval of Bioheart Acute Cell Therapy using the TGI 1200 System has been developed and additional preclinical studies involving pigs, testing for the safety and efficacy of the therapy, commenced in the first quarter of 2007 at Indiana University.
“The results of these Bioheart preclinical studies affirm our belief that the adipose-derived cells isolated from adipose tissue by the TGI System have the potential to assist in the treatment of a variety of medical conditions, including heart attacks,” said Anton C. Krucky, President and CEO, Tissue Genesis, Inc. “We are excited to be associated with the foundational work of Bioheart in this area of potential heart treatment.”