Vitti Labs Announces FDA Approval for Phase II IND Clinical Trial
Vitti Labs LLC, a research and development tissue bank, has announced FDA approval of their Phase II investigational new drug (IND) clinical trial. With this approval, they can move forward with a Phase II Outpatient Clinical Trial using a combination of Umbilical Cord Mesenchymal Stem Cells and Mesenchymal Stem Cell Exosomes to treat Pulmonary Fibrosis secondary to COVID-19.
COVID-19 commonly results in the presence of one of two respiratory manifestations. The first manifestation is a significant reduction in the diffusing capacity of the lungs (FLCO). The second is associated pulmonary interstitial damage. Even a full year after a recovery from COVID-19, the incidence rate of impaired DLCO and persistent lung damage is still over 30%. These persistent complications have caused substantial population morbidity, long-term disability, and even death due to the fibrotic lung progression.
With this study, Vitti Labs believes they will be able to move forward with much needed treatment modalities for these and other respiratory and pulmonary diseases. Vitti Labs is the first to bring a Phase II trial for this treatment using these therapeutics.
The company harvests biomaterials from the umbilical cord and placenta, using their properties to activate and support the repair of the body. They harvest through the bio-ethically donation of birth tissue from healthy and consenting mothers across the United States.
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