American CryoStem Announces FDA Approval of IND to Commence Phase I Clinical Trial for Long COVID/Post-Acute Sequelae of SARS-CoV-2 (PASC)

2023-01-06

细胞疗法临床1期临床申请

Eatontown, New Jersey--(News - January 6, 2023) - American CryoStem Corporation (OTC Pink: CRYO), a clinical-stage therapeutics company with a proprietary end-to-end core biotechnology platform of tissue-based cellular technologies that powers its clinical pipeline, announced today that it has received U.S. Food and Drug Administration (FDA) approval to proceed with a Phase I Clinical Trial for the treatment of Long COVID/PASC. The IND titled "A Pilot Study on Research Treatment of Long COVID/Post-Acute Sequelae of SARS-CoV-2 (PASC) using ATCell™", will assess CryoStem's proprietary ATCell™ therapy for safety and tolerability with the goal to rapidly develop a safe and effective therapeutic for the expansive Long COVID/PASC population afflicted with this life-altering disease. The Study is designed to enroll active-duty military members or their families who are suffering with a confirmed diagnosis of Long COVID. They will be treated with ATCELL™, the Company's autologous mesenchymal cell therapy delivered through intravenous infusion. John Arnone, Chairman and CEO of CRYO, stated, "The Long COVID/PASC IND represents an important milestone for American CryoStem and the approximately 23 million Americans including military service members and their families, suffering from this often-debilitating disease. We are eager to provide the healthcare community with an intervention to help their patients recover." The Company's therapeutic pipeline focuses on medical conditions with high unmet medical need where effective treatments are limited or do not exist. The Long COVID/PASC IND is CRYO's second new drug in development harnessing the Company's ATCELL™ Therapeutics platform. The Company currently has an ongoing Phase I Clinical Trial for Post-Concussion Syndrome (PCS) titled "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." Anthony Dudzinski, COO, commented, "ATCell™ is an autologous adipose tissue derived therapeutic mesenchymal stem cell product with consistent cellular biomarker identification and high repeatable viability that is inherently genetically matched to its recipient." He continued, "American CryoStem's autologous regenerative medicine approach is especially relevant here. Mesenchymal stem cells instinctively hone to damaged areas of the body where they are needed most and can secrete growth factors, cytokines, chemokines, and enzymes to remediate and modulate the body. We believe that each individual's treatment should cater to their own specific condition(s) as PASC is unique to each person." About Long COVID/PASC The US Centers for Disease Control and Prevention (CDC) defines Long Covid as: "A wide range of new, returning, or ongoing health problems that people experience after first being infected with the virus that causes COVID-19." . Of the nearly 24 million adults in the U.S. who currently have long COVID, more than 80% are having some trouble carrying out daily activities, according to CDC data. . More than 42% of adults in the United States reported having had COVID-19, and nearly one in five (20%) are currently still having symptoms of Long COVID. Irrespective of Sars-CoV-2 variant and disease severity, 20% of those afflicted continue to develop Long COVID. As of January 1, 2022, over 661 million cases of COVID-19 were reported globally including over 100.6 million cases in the US, according to the WHO and CDC. An analysis from Brookings states that "2 to 4 million (people) in the US are out of work due to long Covid. The annual cost of those lost wages alone is around $170 billion a year and potentially as high as $230 billion". About American CryoStem Corporation American CryoStem is a clinical-stage therapeutics developer delivering autologous regenerative therapeutics and advanced tissue treatments harnessing the power of mesenchymal stem cells (MSCs) and adipose tissue. We target medical indications with high unmet medical need where effective treatments are limited. The Company's centralized laboratory model and patented "CryoStem Core Platform" is a best-in-class, end-to-end regenerative medicine solution to treat chronic diseases, disorders, and injuries. Through a single adipose-tissue (fat) collection, the Company processes and cryopreserves master samples for a lifetime of therapies on demand; and prepares and CRYObanks pure adipose tissue for serial or multiple advanced treatments. The Company maintains a strategic portfolio of intellectual property [36 patents] that forms its Core Platform consisting of the "Collection - Processing - Cryobanking - Delivery to Point-of-Care" of pure adipose tissue ATGRAFT™, AT-ReStore™ and expanded adipose-derived mesenchymal stem cell (MSCs) ATCELL™ Therapeutics. Our Platform supports a growing pipeline of cellular therapeutics, adipose tissue therapies, products, processes and international licensing opportunities. For further detailed information please visit: , email us at IR@americancryostem.com or call us at 732-747-1007. To view the source version of this press release, please visit