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CRYO) Proclaims FDA Approval of IND to Start Part I Scientific Trial for Lengthy COVID/Submit-Acute Sequelae of SARS-CoV-2 (PASC)

Eatontown, New Jersey – January 6, 2023 (Newsfile Corp.) (Investorideas.com Newswire) American CryoStem Company (OTC Pink: CRYO), a clinical-stage therapeutics firm with a proprietary end-to-end core biotechnology platform of tissue-based mobile applied sciences that powers its scientific pipeline, introduced in the present day that it has obtained U.S. Meals and Drug Administration (FDA) approval to proceed with a Part I Scientific Trial for the therapy of Lengthy COVID/PASC.

The IND titled “A Pilot Research on Analysis Therapy of Lengthy COVID/Submit-Acute Sequelae of SARS-CoV-2 (PASC) utilizing ATCell™”, will assess CryoStem’s proprietary ATCell™ remedy for security and tolerability with the purpose to quickly develop a secure and efficient therapeutic for the expansive Lengthy COVID/PASC inhabitants bothered with this life-altering illness.

The Research is designed to enroll active-duty army members or their households who’re struggling with a confirmed prognosis of Lengthy COVID. They are going to be handled with ATCELL™, the Firm’s autologous mesenchymal cell remedy delivered by way of intravenous infusion. https://clinicaltrials.gov/ct2/present/NCT05669261

John Arnone, Chairman and CEO of CRYO, acknowledged, “The Lengthy COVID/PASC IND represents an necessary milestone for American CryoStem and the roughly 23 million Individuals together with army service members and their households, affected by this often-debilitating illness. We’re keen to supply the healthcare neighborhood with an intervention to assist their sufferers get well.”

The Firm’s therapeutic pipeline focuses on medical circumstances with excessive unmet medical want the place efficient remedies are restricted or don’t exist. The Lengthy COVID/PASC IND is CRYO’s second new drug in improvement harnessing the Firm’s ATCELL™ Therapeutics platform. The Firm presently has an ongoing Part I Scientific Trial for Submit-Concussion Syndrome (PCS) titled “ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed by way of Intravenous Infusion for the Therapy of Submit-Concussion Syndrome (PCS) in Retired Navy and Athletes.”

Anthony Dudzinski, COO, commented, “ATCell™ is an autologous adipose tissue derived therapeutic mesenchymal stem cell product with constant mobile biomarker identification and excessive repeatable viability that’s inherently genetically matched to its recipient.” He continued, “American CryoStem’s autologous regenerative medication method is very related right here. Mesenchymal stem cells instinctively hone to broken areas of the physique the place they’re wanted most and might secrete development components, cytokines, chemokines, and enzymes to remediate and modulate the physique. We imagine that every particular person’s therapy ought to cater to their very own particular situation(s) as PASC is exclusive to every individual.”

About Lengthy COVID/PASC

The US Facilities for Illness Management and Prevention (CDC) defines Lengthy Covid as: “A variety of recent, returning, or ongoing well being issues that individuals expertise after first being contaminated with the virus that causes COVID-19.” https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html/.

Of the practically 24 million adults within the U.S. who presently have lengthy COVID, greater than 80% are having some hassle finishing up day by day actions, in keeping with CDC knowledge. https://www.axios.com/2022/10/06/long-covid-cdc-data-disabling.

Greater than 42% of adults in the USA reported having had COVID-19, and practically one in 5 (20%) are presently nonetheless having signs of Lengthy COVID. Regardless of Sars-CoV-2 variant and illness severity, 20% of these bothered proceed to develop Lengthy COVID. As of January 1, 2022, over 661 million instances of COVID-19 had been reported globally together with over 100.6 million instances within the US, in keeping with the WHO and CDC.

An evaluation from Brookings states that “2 to 4 million (individuals) within the US are out of labor resulting from lengthy Covid. The annual value of these misplaced wages alone is round $170 billion a 12 months and doubtlessly as excessive as $230 billion”. https://www.brookings.edu/analysis/new-data-shows-long-covid-is-keeping-as-many-as-4-million-people-out-of-work/

About American CryoStem Company

American CryoStem is a clinical-stage therapeutics developer delivering autologous regenerative therapeutics and superior tissue remedies harnessing the ability of mesenchymal stem cells (MSCs) and adipose tissue. We goal medical indications with excessive unmet medical want the place efficient remedies are restricted.

The Firm’s centralized laboratory mannequin and patented “CryoStem Core Platform” is a best-in-class, end-to-end regenerative medication answer to deal with power ailments, issues, and accidents. By means of a single adipose-tissue (fats) assortment, the Firm processes and cryopreserves grasp samples for a lifetime of therapies on demand; and prepares and CRYObanks pure adipose tissue for serial or a number of superior remedies. The Firm maintains a strategic portfolio of mental property [36 patents] that types its Core Platform consisting of the “Assortment – Processing – Cryobanking – Supply to Level-of-Care” of pure adipose tissue ATGRAFT™, AT-ReStore™ and expanded adipose-derived mesenchymal stem cell (MSCs) ATCELL™ Therapeutics. Our Platform helps a rising pipeline of mobile therapeutics, adipose tissue therapies, merchandise, processes and worldwide licensing alternatives.

For additional detailed data please go to: www.americancryostem.com, electronic mail us at IR@americancryostem.com or name us at 732-747-1007.

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