Phase II IND clinical trial of combination mesenchymal stem cell and exosome treatment approved

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 their investigational new drug application (IND) to move forward with phase II outpatient clinical trial using a combination of umbilical cord mesenchymal stem cells and mesenchymal stem cell exosomes for the treatment of pulmonary fibrosis secondary to novel coronavirus infection (COVID-19). Vitti labs is the first to bring a phase II trial for this treatment using these therapeutics.

Two of the most common respiratory manifestations of COVID-19 are a significant reduction in the diffusing capacity of the lungs (DLCO) and the associated pulmonary interstitial damage. One year after moderate COVID-19, the incidence rate of impaired DLCO and persistent lung damage still exceeds 30%, or one-third of the patients develop severe DLCO impairment and fibrotic lung damage. The persistent respiratory complications may cause substantial population morbidity, long-term disability, and even death due to the fibrotic lung progression.

The long-lasting sequelae in patients who have recovered from severe COVID-19 indicate that there is a 30% chance of developing a persistent respiratory system pathology and a 10% chance of developing a severe pathology. This includes the severe disruption of respiration, reduction of exercise tolerance, and the concomitant development of persistent fibrotic lung damage

Vitti Labs believes that with this study, they will be able to move forward with groundbreaking treatment modalities for other pulmonary diseases, such as COPD and Cystic Fibrosis.

Source – PR Newswire