Convalescent Plasma (CP), also called Passive Antibody Therapy for the treatment of COVID-19 infected patients was approved by the US-FDA on August 23, 2020!
LAUSANNE, Switzerland, Oct. 27, 2020 /PRNewswire/ -- This great news was based on a nationwide evaluation in 14 US medical institutions. 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).
This new A-CP tube encompasses different published recommendations. The first studies performed in 1945 with the low-doses of human immune serum to prevent several infectious diseases, such as Hepatitis or Smallpox during epidemic period, showed great success:
- the first study showing the efficacy of human plasma was performed by Dr Neefe and Dr Stokes in 1945! This study was performed on more than 10 000 patients and it showed a reduction of the hepatitis incidence from 3 to 8 times for patients receiving 10cc of human plasma!
- another study was performed by the same doctors during an extensive hepatitis outbreak on 331 patients. For patients receiving a small dose of human plasma (0,33mL/kg which correspond to ~ 20mL/patient) this study showed an 87% reduction in the attack rate!
- World Health Organization published as well a study in 1962 in order to determine the prophylactic value of immune gammaglobulin on a total of 705 patients suffering from smallpox with 5 or 10mL pooled plasma injected intramuscularly. This study showed a reduction of the smallpox incidence by 70%!
It encompasses also 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.
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 developed with the support of InnoSuisse, 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.
An evaluation performed by Dr Luca Santoleri, head of the transfusion department at the San Raffaele Hospital (Milan, Italy), showed recovery of almost 100% of the IgG antibodies without cellular contamination.
Furthermore, the patent has been listed in March 2020.
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.
Additional information about RegenLab and its patents can be found at: https://www.regenlab.com/corporate/patents // firstname.lastname@example.org
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