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American CryoStem Engages BioSolutions Clinical Research Center, LLC. and Principal Investigator for Chronic Concussive Syndrome IND
EATONTOWN, NJ / ACCESSWIRE / September 11, 2019 / American CryoStem Corporation (OTC PINK:CRYO) a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular products and technologies for the Regenerative and Personalized Medicine industries, today announced that it has contracted with BioSolutions Clinical Research Center, LLC. (“BioSolutions”) to conduct a clinical study (“Study”) of ATCELL™ (“Investigational Drug”) as part of a single center study under a protocol entitled: ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed via Intravenous Infusion for the Treatment of Post Concussion Syndrome (PCS) in Retired Military and Athletes during CRYOs Investigational New Drug (IND) filing with the FDA.
BioSolutions located in La Mesa, CA. is dedicated to clinical research with over 25 years of collective experience in the fields of medicine, and clinical trials from Orthopedics to Stem Cells. BioSolutions is comprised of community based investigators dedicated to overseeing all aspects of the clinical trials plus an experienced team of clinical research professionals focusing on quality research data while recognizing that speed, responsiveness and accountability are also core needs.
BioSolutions’s expertise and previous experiences with cellular therapy trials and local clinical sites provide sponsors with consistent subject enrollment and accurate data. BioSolutions, conducts clinical trials in both Industrial Sponsored Research (ISR) and Stem Cell Research (SCR).
Peter Hanson, MD, Medical Director of BioSolutions has been appointed as the Primary Investigator (PI), along with co-investigator Dr. Tal David for the Company’s study. During Dr Hanson’s career he has participated in approximately 41 clinical studies of which he led 24 as principal investigator. His clinical studies have been sponsored by many of the biggest names in the pharmaceutical and biotech industry such as Pfizer, Sanofi, Bristol Meyers Squibb, Regeneron, Cytori and InGeneron. Dr. Hanson joined Grossmont Orthopedic Medical Group in August of 1992. He has been Chief of Orthopaedic Surgery and has served as the Medical Director of Orthopedic Surgery, Chief of Staff, as well as Chairman of the Board of Directors at Grossmont Hospital. He is a member of The American Academy of Orthopedic Surgery, The American Association of Hip and Knee Surgeons, Dr. Hanson specializes in joint replacement. Dr. Tal David specializes in sports medicine and is a team physician with the NFL and NHL.
Anthony Dudzinski, COO stated: “This is a first of its kind cellular therapy clinical study utilizing adipose derived cultured mesenchymal stem cells that initially seeks to confirm the safety of individual infusion therapy to address the significant inflammatory response to concussive injury. Concussion injury has been well documented in scientific literature and by the NFL and the US Armed Forces. We believe that many other sports, such as Soccer, Boxing, MMA, Hockey, Baseball and Basketball have large populations of athletes affected by concussions.
To date treatment of these conditions has been limited to symptomatic identification and treatment. We also believe that once we establish safety we will be able to partner with additional clinicians and clinical research centers to study alternative applications of our product and method of administration to target additional unmet medical needs that we believe can be addressed with autologous cellular infusion therapies.”
Dr. Hanson stated; “Our team has worked hard with American CryoStem to prepare this novel autologous cellular therapy protocol for the treatment of Post Concussion Syndrome. Many of our Sports Medicine patients, in addition to their orthopedic injuries are affected by repeated concussions through the life of their sports career. Chronic Concussive Syndrome and Post Concussion Syndrome at this time had no approved pharmacology or biotherapy solution and there is a significant unmet medical need for a safe and effective therapy.”
Overall, it is estimated that the cost of traumatic brain injuries (TBI) in the United States weighs in at $48.3 billion annually. About $31.7 billion of that is spent on hospitalization costs, while the additional $16.6 billion goes toward costs associated with fatalities. According to the Center for Disease Control, acute care and rehabilitation of brain injury patients in the United States costs about $9 billion to $10 billion per year. This does not include indirect costs to society as well as to families, including costs associated with lost earnings, work time, and productivity, as well as the costs linked to providing social services. https://www.brainandspinalcord.org/cost-traumatic-brain-injury/
The Company recognizes the significant market opportunity for its new autologous cellular therapy treatment modality for the treatment of Post Concussion Syndrome and mild Traumatic Brain Injury via infusion therapy of Autologous Expanded Adipose Derived Mesenchymal Cells and intends to leverage its early clinical study using this delivery protocol for the treatment of other diseases and muscle-skeletal injuries with significant multibillion dollar treatment and therapy markets.
This press release may contain forward-looking statements, including information about management's view of American CryoStem Corporation's ("the Company") future expectations, plans and prospects. In particular, when used in the preceding discussion, the words "believes," "expects," "intends," "plans," "anticipates," or "may," and similar conditional expressions are intended to identify forward-looking statements. Any statements made in this press release other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of the Company, its subsidiaries and concepts to be materially different than those expressed or implied in such statements. Unknown or unpredictable factors also could have material adverse effects on the Company's future results. The forward-looking statements included in this press release are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by American CryoStem Corporation.
SOURCE: American CryoStem Corporatio
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