The Company and the Principal Investigator announce the addition of sub-investigators to the clinical trial team with extensive experience assessing and treating athletes and military personnel suffering from concussion injury, traumatic brain injury and Post Concussion Syndrome.
EATONTOWN, NJ / ACCESSWIRE / October 3, 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 the selection of three new Investigators to assist the Principal Investigator with CRYO’s Phase I clinical 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.
Dr. Tal David, a Sport Medicine specialist and former NFL Head Team Physician for the San Diego Chargers, is going to be the Co-Principal investigator for the study. Sub-Investigators, Dr. Jason Bailie, PhD, Senior Clinical Research Director at the Defense and Brain Injury Center (DVBIC) at the Naval Hospital Camp Pendleton, CA and Dr. Ettenhofer, Director of Research Operations, Defense and Veterans Brain Injury Center (DVBIC) Naval medical Center, San Diego, CA were the key designers of the evaluation aspect of the study. This included advising on the pre-treatment evaluations to rule out complex psychological co-pathology as well as the outcome measures to follow the efficacy of the treatments, since the chronic injuries seen in athletes mirrors those issues found in the military with multiple concussions and blast injuries.
Under the direction of Dr. Hanson and Dr. David, the sub-investigators will be responsible for assessing and screening all applicants for participation and completing the ongoing assessment of each participant. These evaluations include patient physical and neuropsychological assessment, testing and screening, preparation of source documentation and collection of assessment results, and assistance with completion of the final study reports and publications. The surgical tissue collection, ATcell treatments and follow up clinical visits will be conducted at BioSolutions Clinical Research Center facility in Le Masa, CA. The Company is pleased to present a world class team with significant experience in chronic concussion syndromes.
PRINCIPAL INVESTIGATOR: Dr. Peter Hanson, MD, as previously announced on September 11, 2019, has been appointed as the Principal Investigator, for the Company’s study. Dr. Hanson is also Medical Director of BioSolutions Clinical Research Center the clinical research facility engaged by the Company to conduct the 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.
CO-PRINCIPAL INVESTIGATOR: Dr. Tal David, M.D. is a board-certified orthopedic surgeon specializing in arthroscopic and sports medicine surgery, is certified in both Orthopedic Surgery and Orthopedic Sports Medicine. He practices in San Diego, CA as part of the Synergy Specialists Medical Group and the San Diego Stem Cell Treatment Center. He is a clinical faculty member of Orthopedic Surgery at UC San Diego and a faculty member of the San Diego Arthroscopy and Sports Medicine Fellowship. He has cared for injured athletes for 15 years and has served on the medical staff of various professional sports teams including more than 11 years as an NFL team physician. In addition to his private practice, he served as the former Head Team Physician for the San Diego Chargers NFL football team and is Medical Director for the San Diego Gulls, AHL hockey team.
SUB-INVESTIGATOR: Jason M. Bailie, Ph.D, is a neuropsychologist who serves as Senior Clinical Research Director of the Defense and Veterans Brain Injury Center (DVBIC), Naval Hospital in Camp Pendleton, CA. Dr. Baille currently directs research, clinical and educational activities and supervises research staff. He is responsible for clinical research program development, experimental design, human-subject recruitment, experimental procedural implementation, data acquisition, and statistical analysis for local and multi-site research studies. Additional duties include oversight of research compliance with Institutional Review Board for the Department of Navy, Department of Defense clinical research and human subject research policies; and facilitating grant acquisitions and management. He supervises a clinical staff of social workers and psychologists, educational outreach personnel and provides educational presentations and grand rounds to providers and service members in collaboration with DVBIC Regional Education Coordinator.
SUB-INVESTIGATOR Mark L. Ettenhofer, Ph.D is a neuropsychologist and Director of Research Operations American Hospital Services Group (AHSG), Defense and Veterans Brain Injury Center (DVBIC), Naval Medical Center, San Diego (NMCSD): San Diego, CA.Dr. Ettenhofer’s primary research focuses on the development and evaluation of novel approaches for neurocognitive assessment and rehabilitation of traumatic brain injury (TBI) for the US Navy. Dr. Ettenhofer currently directs DVBIC supported traumatic brain injury (TBI) research at NMCSD, including 8 approved protocols evaluating novel technologies for TBI assessment, methods for remediation of TBI-related impairment, natural history of TBI, and guidelines for progressive return to activity after injury. Additionally he provides programmatic review for DVBIC national research portfolio, supervises and mentors eight full-time staff members in research activities and is well published.
Overall, it is estimated that the cost of traumatic brain injuries (TBI) in the United States weighs in at $48.3 billion annually of which $31.7 billion is spent on hospitalization costs; an additional $16.6 billion is associated with costs attributed to 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 and family caretakers due to lost productivity, work time and earnings, as well as costs linked to providing social services.
The Company stated that “The successful assembly of this expert team of investigators who are currently treating athletes and military personnel suffering from Concussive and Traumatic Brain Injury is a major step towards properly implementing, monitoring and effectively evaluating the treatment of the participants with ATcell. Working with this expert team will expand the Company’s knowledge for treating concussion injury, traumatic brain injury and Post Concussion Syndrome and accelerate its ability to complete this Phase 1 study and provide the necessary input to continue our work toward final FDA approval of ATcell for Post Concussion Syndrome.
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SOURCE: American CryoStem Corporation