Stem cell-based product, intended for the treatment of patients with Covid-19, will be tested in Brazil.
Anvisa approved last week the clinical trial of the advanced therapy product for the treatment of Covid-19, called COVI-MSC TM. Developed by the American company Sorrento Therapeutics Inc, represented in Brazil by Synova Pesquisa Científica, the product is based on adipose tissue-derived menenchymal stem cells expanded by allogeneic culture.
The authorized study is a phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy in the treatment of acute respiratory discomfort caused by Covid-19. In Brazil, 100 volunteers are expected to participate at clinical sites.
Monitoring of the clinical trial will be conducted by the Data Monitoring Committee – DMC, which is independent, and should analyze the data and ensure the safety of study participants, in addition to making recommendations to the sponsor. Anvisa, in turn, has also established strategies and commitments with the sponsor for intensive monitoring of the clinical trial.
What are Advanced Therapy Products?
These are innovative therapeutic products developed from human cells or genes. These products, considered special drugs, are subject to registration at Anvisa. It is worth noting that every clinical trial with these products must be evaluated by the Agency.
Advanced therapy products can only be administered to patients after registration and according to the manufacturer’s or producer’s instructions. It is the responsibility of the registration holder to provide unequivocal proof of the elements of safety, efficacy, and quality.
During the development and controlled research phase, clinical indications, special care during and after use, quality attributes, and also major adverse reactions and risk management criteria are defined.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.