Organicell Regenerative Medicine, Inc. a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Organicell Flow, for patients diagnosed with moderate to severe acute respiratory syndrome (SARS) due to COVID-19 infection.
This trial will be the first randomized, double-blinded, placebo-controlled, phase I/II multi-center clinical trial investigating the safety and potential efficacy of amniotic fluid sourced components for COVID-19.
“This IND approval is an important first step in Organicell’s evolution into becoming a global leader in FDA approved regenerative medicines. We are excited to initiate this FDA clinical trial as well as continue to progress our other clinical programs in biological regenerative therapies,” said Albert Mitrani, Chief Executive Officer at Organicell.
Organicell Flow is a natural and acellular product derived from amniotic fluid and is manufactured to retain the naturally occurring hyaluronic acid, proteins, and exosomes present in perinatal fluid without the addition or combination of any other substance or diluent. Organicell products are manufactured in cGMP compliant labs and are tested for sterility, endotoxin levels, hyaluronic acid, protein analysis, and exosomes composition. Exosomes are nano-sized extracellular vesicle that mediate cell-to-cell communication and affect cell function and behavior.
“We’ve been evaluating Organicell Flow for a while now. We’ve been analyzing the exosome components to reveal a variety of microRNA factors that could potentially promote tissue homeostasis and repair. We are thrilled to be able to take this research into FDA trials,” said Dr. George Shapiro, Chief Medical Officer at Organicell.
Source – Globe Newswire