American CryoStem is set to proceed with a Phase I clinical trial of its ATCELL therapy to treat Long Covid/PASC, following the receipt of investigational new drug (IND) application approval from the US Food and Drug Administration (FDA).
Titled ‘A Pilot Study on Research Treatment of Long Covid/Post-Acute Sequelae of SARS-CoV-2 (PASC) using ATCell’, the study has been designed to evaluate the cell therapy for tolerability and safety.
The randomised, double-blinded, single-centre, placebo-controlled, standard-of-care plus trial aims to rapidly develop a safe therapeutic for expansive Long Covid/PASC disease patients.
Active-duty military members, or their families, who are diagnosed with Long Covid will take part in the trial, which is expected to commence in April this year.
The participants will receive ATCELL, the company’s autologous mesenchymal cell therapy, through intravenous infusion.
American CryoStem chairman and CEO John Arnone said: “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 noted that the Long Covid/PASC IND is its second new drug being developed using the ATCELL therapeutics platform.
At present, it is conducting an ongoing Phase I clinical trial for Post-Concussion Syndrome (PCS).
American CryoStem COO Anthony Dudzinski said: “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.
“We believe that each individual’s treatment should cater to their own specific condition(s) as PASC is unique to each person.”
