Operating market.
The search for solutions that bring longevity with quality of life in Brazil is now possible, as studies advance for product registration and use of stem cells, and for R-Crio's client, who can use the cells if necessary, supported by Anvisa's regulations.
Overview
Chronic and degenerative diseases represent one of the greatest challenges for global and Brazilian public health, especially in a scenario of increasing longevity. With advances in medicine and quality of life, infectious diseases have been largely controlled, but, on the other hand, we have seen a significant increase in illnesses such as arthritis, stroke, heart disease, diabetes, Alzheimer's and Parkinson's. In addition, factors such as inadequate nutrition, sedentary lifestyle and exposure to pollutants have contributed to the incidence of cancer, muscular and respiratory problems.
Leading causes of global mortality
Source: Our World In Data, Causes of death, 2019
Global perspectives
In the short term, healthcare systems are already facing challenges due to the growth of these conditions, resulting in high treatment costs and an impact on patients’ quality of life. In the medium and long term, the elderly population is expected to increase significantly — in Brazil, for example, it is estimated that by 2050, 30% of the population will be over 60 years old. This population aging requires innovative solutions to ensure not only a longer life expectancy, but also healthy aging. In this context, regenerative medicine and cell therapies, such as the use of stem cells, emerge as a hope for reversing or delaying the damage caused by these diseases, promoting a more effective and personalized approach to healthcare.
Expectativa de vida do Brasil e Mundo
Source: Our World In Data, Life Expectancy 2023
Mesenchymal stem cells in the spotlight in academic and scientific circles.
Mesenchymal stem cells (MSCs) have emerged as one of the main focuses of regenerative medicine for the treatment of several degenerative and inflammatory diseases. Their versatility allows them to differentiate into multiple cell types, including bone, cartilage, muscle, neurons and even insulin-producing cells. In addition, they have natural immunomodulatory and anti-inflammatory properties, which makes them promising for the treatment of autoimmune diseases, musculoskeletal injuries, heart disease and even neurological conditions, such as stroke and Alzheimer's.
The academic community has invested heavily in research on MSCs, with more than 8,000 scientific articles published in 2021. Universities and research centers have explored their therapeutic potential for tissue regeneration and the development of personalized biological medicines. The cryopreservation approach for these cells has also been gaining relevance, as it allows them to be stored young and healthy for future use, maximizing their regenerative potential and opening doors to innovative and less invasive treatments.
Source: PUBMed, 2023
Use of stem cells in Brazil and regulatory frameworks .
Contrary to what many people think, we are quite advanced in terms of the use of stem cells in Brazil. This is because Anvisa has already brought great advances to this technology in Brazil, based on regulations from places where these therapies are already frequently performed, such as Japan, the USA and Europe.
Anvisa's latest resolution, published in 2020 and revised in 2021, sets out the rules on how researchers with advanced and proven treatments can register cell therapies commercially, with a package insert, patent and trade name.
Created in 2018 and revised in 2021, this resolution presents the best way to carry out clinical trials (research with people) with stem cells, including how to declare the results and recruit qualified professionals.
Published in early 2018, and also revised in 2023, the resolution provides for the existence of laboratories called Cell Processing Centers (such as R-Crio), prepared to store but also deliver stem cells for therapies.
Advanced Cell Therapy Products (ATPs) approved worldwide.
There are several approved advanced cell therapy products around the world, according to the Alliance for Regenerative Medicine website. See below some approved products.
Alofisel
Alofisel is an allogeneic stem cell therapy used to treat complex perianal fistulas in patients with Crohn's disease. Approved in the European Union.
Caristem
Cartistem is a cellular therapeutic agent containing mesenchymal stem cells derived from allogeneic human umbilical cord blood. It is approved for the treatment of knee cartilage defects such as traumatic articular cartilage injuries, degenerative arthritis, and rheumatoid arthritis. Approved in South Korea.
Cellgram-AMI
Cellgram-AMI is an intracoronary autologous injection of bone marrow-derived mesenchymal stem cells for the treatment of acute myocardial infarction. Approved in South Korea.
Cupistem
Cupistem is an autologous adipose-derived mesenchymal stem cell treatment used to reduce inflammation and regenerate damaged joint tissue. Approved in South Korea.
CureSkin
CureSkin is an autologous dermal fibroblast-based therapy. It is approved for the treatment of depressed acne scars. Approved in South Korea.
FUCKS
FUCASO is a BCMA-targeted CAR-T therapy for the treatment of relapsed or refractory multiple myeloma. Approved in China
Holoclar
Holoclar is a cell therapy based on autologous cultures of limbal stem cells. It regenerates the functional corneal epithelium, allowing the recovery of visual acuity. Approved in the European Union.
Kaloderm
Kaloderm is an allogeneic cell therapy for the treatment of deep second-degree burns and diabetic foot ulcers. Approved in South Korea.
KeraHeal
KeraHeal is an autologous keratinocyte-based cell therapy. It is approved for the treatment of second-degree burns. Approved in South Korea.
KeraHeal-Allo
KeraHeal-Allo is a therapeutic hydrogel product based on allogeneic keratinocytes. It is used for the treatment of second-degree burns. Approved in South Korea.
Lantidra
Lantidra is an allogeneic cell therapy consisting of pancreatic islets from deceased donors for the treatment of type 1 diabetes. It is approved for adults with type 1 diabetes who are unable to achieve target levels of glycated hemoglobin (average blood glucose levels). Approved in the United States.
ALOFISEL
Alofisel is an allogeneic stem cell therapy used to treat complex perianal fistulas in patients with Crohn's disease. Approved in the European Union.
Neuronata-r
Neuronata-R is an autologous bone marrow-derived mesenchymal stem cell therapy. It is approved for the treatment of amyotrophic lateral sclerosis (ALS). Approved in South Korea.
Omisirge
Omisirge is a NAM-enhanced stem cell therapy for hematologic malignancies indicated for patients receiving umbilical cord blood transplantation after myeloablative conditioning. Its goal is to reduce neutrophil recovery time and the incidence of infections. Approved in the United States.
LaViv (Azficel-T)
LaViv is an autologous fibroblast-based cell therapy. It is approved for the improvement of the appearance of moderate to severe wrinkles in the nasolabial folds in adults. Approved in the United States.
TEMCELL
TEMCELL is a therapy for acute radiation injury, chronic obstructive pulmonary disease, Crohn's disease, acute graft-versus-host disease, type I diabetes, and myocardial infarction. Approved in Japan, Canada, and New Zealand.
Vyznova
Vyznova is a cell therapy for the treatment of bullous corneal keratopathy. Approved in Japan.
Spherox
Spherox is a product containing human autologous chondrocyte spheroids, used for the treatment of cartilage defects. Approved in the European Union.
Stempeucel
Stempeucel is an allogeneic adult mesenchymal stromal cell therapy cultured ex vivo. Approved for: Critical Limb Ischemia. Approved in India.
Queencell
Queencell is an autologous mesenchymal stem cell therapy for the treatment of connective tissue disorders. Approved in South Korea.
Stemirac
Treatment for spinal cord injury. Approved in Japan.
Rosmir
Treatment of under-eye wrinkles with autologous mesenchymal cells. Approved in South Korea.
Source: Alliance for Regenerative Medicine, 2025