Vitti Labs, an AATB Accredited Tissue Bank focused on Life Science Research, Development and Manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to conduct Phase II Clinical Trials using a combination of Umbilical Cord Mesenchymal Stem Cell and Umbilical Cord Mesenchymal Stem Cell Exosomes for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with the Novel Corona Virus (COVID-19). This marks the very first time the FDA has approved an IND that uses both of these components together and so first of its kind therapy.
This therapy is designed to suppress the pro-inflammatory processes in the pulmonary system that occurs in COVID patients, while simultaneously alleviating pulmonary distress, such as acute lung injury and inflammation as seen in ARDS (Acute Respiratory Distress Syndrome). In addition to its anti-inflammatory and anti-fibrotic properties, the combination therapy aims to reduce oxidative stress. This Phase II study will evaluate the utility of intravenous umbilical cord mesenchymal stem cells and exosomes in mitigating the pulmonary consequences of COVID-19. As this treatment has already shown tremendous promise in the treatment for ARDS associated with COVID-19, the completion of this Phase II Clinical Trial is expected to conclude in Q1 of 2022.
Philipp Vitti, Chief Scientist of Vitti Labs, stated, “We are very excited to be the first FDA Approved IND to have Umbilical Cord Mesenchymal Stem Cells and their Exosomes being utilized together as a multi-dose combination therapy for IV use. The preliminary trials have been overwhelmingly successful. Mesenchymal Stem Cells and their exosomes have unique therapeutic benefits, and together they create advanced therapeutic properties. This application approval is a great advancement in the ongoing progress to utilize Umbilical Cord Mesenchymal Stem Cells and Exosomes for different disease models, and Vitti Labs is excited and proud to contribute their resources to finding effective treatment options for the worldwide pandemic.”
Source – PRNewswire