Kimera Labs Inc., a Florida-based global MSC exosome research lab and producer, announced on Tuesday that it has received FDA IND (Investigational New Drug) approval of its exosomes in a Phase I/IIa clinical trial.
The trial is to evaluate the safety and efficacy of a single intravenous dose of an isolated, proprietary placental cell line derived, mesenchymal stem extracellular vesicles for the treatment of COVID-19 symptoms in adults with mild to moderate illness.
Kimera Labs will recruit COVID-19 patients for the IV administration of its exosome products commencing in June. This Phase I/IIa study will thoroughly investigate the safety and clinical efficacy of its advanced exosome products and technology. The Company anticipates completing its Phase I/IIa trial in a matter of months, and then to seek approval to commence the final Phase 3 study.
The company's exosomes are developed at its 28,000 square feet FDA GMP-inspected manufacturing facilities in Miramar, Florida. The firm has set up a clinical and research team to prioritise future IND clinical FDA submissions to leverage the regenerative and anti-inflammatory properties of its exosomes.
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