Brazilian Regulatory Scenario
Therapies that use stem cells grown in the laboratory are part of a special class of medicines, called Advanced Therapeutic Products (ATPs). Thus, stem cell therapies are literally medicines, with production requirements similar to those of common medicines that we already know.
How do cell therapies work in Brazil?
In Brazil there are two types of stem cell therapies: conventional and advanced therapies.
Conventional Cellular Therapies
These are bone marrow transplants or application of PRP (platelet-rich plasma). In this case, the cells must perform the same function as the donor in the recipient and cannot be multiplied. These therapies are medical procedures, not biological medications. The stem cells stored in R-Crio are not part of this classification.
Advanced Cellular Therapies
Advanced cell therapies are those in which stem cells are multiplied and may have a different function than their original. These therapies are considered advanced because there is cell multiplication, material transportation, freezing and thawing, and other processes that require greater control. The cells stored in R-Crio are part of this category.
And what is the biggest difference between them?
When we talk about Advanced Cellular Therapies (stem cells stored in R-Crio), we are talking about isolated, concentrated stem cells with extensive quality controls. Medical procedures that seek to obtain a cell concentrate, for example, have concentrations of stem cells but also with many other cells mixed in, leading to a lack of standardization and uncertainty in the results of that therapy.
R-Crio's proposal is to deliver a stem cell medicine with total control over the quality and quantity of the stem cells present.
Who can use stem cells today in Brazil?
Advanced Cellular Therapies are still under development, that is, in the process of clinical trials to become a medicine for use by the entire population. However, RDC 505/2021 (see below) explains how these products can be used even before having a registered product:
Compassionate Use: when the product is not produced routinely, for a specific patient, in a condition of imminent life-threatening risk, for the treatment of a disease with no therapeutic alternative available in the country, and under the responsibility of a qualified professional. This can be found in Art. 13 of RDC 505/2021.
Clinical research: with a research protocol registered with Anvisa, the patient's cells can be requested upon presentation of research documents.
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