FDA approves Phase II clinical trial of combination treatment for COVID-19

pharmafile | October 28, 2021 | News story | Business Services  

The FDA has approved Vitti Labs’ Investigational New Drug (IND) application to conduct Phase II Clinical Trials using a combination of mesenchymal stem cell and exosome treatment for COVID-19 infection.

Vitti Labs will use a combination of Umbilical Cord Mesenchymal Stem Cell and Umbilic Cord Mesenchymal Stem Cell Exosomes for the treatment of Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19.

This is the first time the FDA has approved an IND that uses both of these components together, and is therefore a novel therapy.

The therapy is designed to suppress the pro-inflammatory process 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. In addition to being anti-inflammatory and anti-fibrotic, the combination therapy aims to reduce oxidative stress.

Vitti Labs is a tissue bank which focuses on life science research, development, and manufacturing. Their Phase II study will evaluate the efficacy of intravenous umbilical cord mesenchymal stem cells and exosomes in reducing the pulmonary consequences of COVID-19, and the completion of this 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.”

Lina Adams

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