CLBS119 was conceived and launched as a development program in the early stages of the COVID-19 pandemic based on the then available characterization of the disease, its available treatments, and the anticipated treatable patient population. Fortunately for patients, the acute COVID-19 treatment regimens improved significantly throughout 2020 leading to decreased use of ventilatory support. This fact, coupled with the recent approval of an effective vaccine and the anticipated approval of additional effective vaccines in the near future, has dramatically changed the profile and prognosis of COVID-19 patients with chronic lung debilitation and led to a lack of patients with long-term hypoxia – Note: Receiving ventilatory support and demonstrating chronic hypoxia are inclusion criteria for enrollment in the CLBS119 pilot trial.
Given these recent developments, and in recognition of the fact that the characterization of the COVID-19 patient suffering long-term effects continues to evolve, Caladrius has decided to suspend the execution of the pilot study of CLBS119. Future development of CLBS119 will be predicated on the identification of an underserved treatable population with a stable profile.
Human Coronavirus Disease 2019
In December 2019, when a new pneumonia-like illness in China was identified as “Coronavirus Disease 2019” (COVID-19), Caladrius moved quickly to determine whether our CD34+ cell technology could play a role in responding to the growing public health threat. COVID-19 is caused by the virus “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The extent of the disease, its epidemiology, pathophysiology and clinical manifestations are being well-documented on an ongoing basis (Guan et al. 2020; Yang et al. 2020).
Guan, W. J., et al. 2020. 'Clinical Characteristics of Coronavirus Disease 2019 in China', N Engl J Med.
Yang, Y., et al. 2020. 'The deadly coronaviruses: The 2003 SARS pandemic and the 2020 novel coronavirus epidemic in China', J Autoimmun: 102434.