A clinical study was approved, combining phases 1 and 2, with an advanced therapy product such as cell therapy for the treatment of Covid-19.
Anvisa approved, on Wednesday (4/11), a clinical study with an advanced therapy product for the treatment of Covid-19. The study called “Hope”, is the first controlled in Brazil and authorized by the Agency with mesenchymal stem cells, originating from human tooth pulp. It is a clinical study that integrates phases 1 and 2.
Sponsored by the Brazilian company Cellavita Pesquisa Científicas Ltda., The main objective of the study is to evaluate the safety of the use of the NestaCell® product and to verify the evidence of effectiveness in improving the clinical condition and inflammatory profile of patients with Covid-19 hospitalized without invasive ventilatory support.
90 patients are expected to participate, 45 of whom will be part of the “Test” group and will receive NestaCell®. The other half will participate in the “Control” group, in which the placebo will be administered. The placebo is produced to look like the real treatment, but it has no active component. It is used in research groups to assess the effects of the product. In other words: it is expected that the “Control” group, which will receive a placebo, will not present any adverse event or clinical improvement – in contrast to the other group that will use the product and that the unwanted events will be observed and still need to show a substantial improvement for prove evidence of the effectiveness of the treatment being evaluated.
[huge_it_slider id=”15″]Clinical research should be carried out in several Brazilian clinical centers, with approval from the National Research Ethics Commission (Conep / MS), and will be supervised by an Independent Safety Monitoring Committee. This committee is made up of independent experts in order to monitor the safety data collected during the clinical trial. It is important to note that Anvisa has established a series of strategies and commitments to the sponsor for the intensive monitoring of the clinical study.
Advanced therapy products
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Among the advanced therapy products, the products of the CAR-T category, based on blood cells (T lymphocytes) genetically modified in the laboratory, and products based on mesenchymal cells, produced in the laboratory from stem cells, stand out. originated from an individual or from cell banks.
For administration to patients, these products must be registered with Anvisa and follow the instructions of the producer or manufacturer. The registry holder is responsible for verifying, unequivocally, the elements of safety, efficacy and quality of the products. It is in the development and controlled research phase that, for example, clinical indications, main adverse reactions, special patient care during and after use, as well as critical quality attributes are defined.
Attention! For now, there is no registration and approval in Brazil of advanced cell-based therapy products. On the other hand, clinical studies controlled and monitored by the Agency are in progress, which follow the care required for the safety of the participants and the integrity of the data.
Regulations and exceptional cases
The Resolution of the Collegiate Board (RDC) 338/2020, which provides for the registration of advanced therapy products, defined some emergency and exceptional situations. These are situations that involve imminent risk of life, in which the doctor can assume the responsibility of administering a certain advanced therapy product, provided that it is produced according to Good Manufacturing Practices (GMP) and with the patient’s consent. The patient must be aware that it is a procedure with an experimental product, not subject to commercialization and intended for certain cases under specific medical care. The legislation defines that these exceptional cases must be notified and authorized (in the case of gene therapy) by Anvisa.
Source: Anvisa