Convalescent Plasma (CP), also called Passive Antibody Therapy, for the treatment of COVID-19 infected patients was approved by the US-FDA two weeks ago.
This great news was based on a nationwide evaluation in 14 U.S. medical institutions, and a report on 20,000 patients shows the safety and benefit of CP, specifically on the seven-day mortality rate as published by Dr. Michael Joyner and Prof. Arturo Casadevall, and has justified the “breakthrough” acceleration process for the US-FDA approval.
As a specialist of plasma technologies, Regen Lab has designed and patented a new 20 ml tube for the reproducible and standardized production of 10 ml of convalescent plasma, the Acellular-Convalescent Plasma Tube (A-CP). Evaluations by Dr. Luca Santoleri, head of the transfusion department at the San Raffaele Hospital (Milan, Italy), show recovery of almost 100% of the IgG antibodies without cellular contamination.
This new A-CP tube encompasses the published recommendations of Prof. Arturo Casadevall, who leads the research in this critical passive antibody therapy since the first SARS 1 outbreak in 2003, i.e., small doses of CP (from 10 to 40 ml) for the treatment and prophylaxis for personal health care and early infected patients or patients having a high exposure risk (The convalescent sera option for containing COVID-19. Arturo Casadevall, Liise-anne Pirofski. J Clin Invest. 2020).
During the lockdown, the Regen Lab R&D team has been focused on the design of new 20 ml tubes for different therapeutic applications:
- new medical devices containing a specific and complex polymer for the depletion of all cellular blood components, except useful antibodies, for the preparation of convalescent plasma: the 20 ml tube is processed and ready to use in 20 minutes which is significantly faster than plasmapheresis, which takes 24 hours or more,
- 20 ml tubes for Platelet Rich Plasma (PRP) and Bone Marrow Concentrate (BMC) production, and
- specific medical devices for the use of membranes in dentistry and tendinopathies or alopecia.
It’s a busy summer for the scientific team, with the issue of a new CE mark valid until May 2024, MDSAP audit renewal and the publication of the new book “Standardized Platelet-Rich Plasma for Musculoskeletal Disorders”.
Furthermore, patent authorities have released seven new patents (Israel, South Korea, Europe, India and Eurasia) for Regen Lab’s medical devices.
Despite the consequences of the pandemic around our planet, stars are lining up for the Regen Lab team.
Regen Lab, founded in 2003 by Mr. Antoine Turzi with its HQ/facility in Switzerland and R&D in Europe and New York, is a leading innovator of medical devices for the preparation of platelet rich plasma (PRP) and combination therapies with hyaluronic acid, which it markets under the well-recognized REGENLAB, REGENKIT and CELLULAR MATRIX fig. brands.
Source: Company Press Release