Is stem cell therapy safe?

The capabilities of modern medicine with the use of scalpels and medicines have apparently reached their peak, and hundreds of diseases are still considered incurable. Life also poses new challenges, such as COVID-19. Thus, scientists’ hopes of overcoming genetic diseases, irreversible changes in tissues and organs due to aging or disease (myocardial infarction, stroke) and disability are linked to stem cell potential and gene technologies.

Many people still mistakenly associate the term “stem cells” with embryonic tissues, although science has learned to isolate them from virtually all adult tissues. It is the presence of these undifferentiated cells in the human body throughout life provides wound healing, fracture healing, monthly recovery of the endometrium in women, constant hematopoiesis. However, with age, the number of stem cells in the tissues decreases, and accordingly the regenerative potential of the senile organism suffers.

Modern scientists also attribute the appearance of a number of malignant tumors to the “misbehavior” of their own stem cells, present from birth in the body, which would normally only provide regeneration. But this knowledge allows us to develop new approaches to the treatment and prevention of cancer.

The regenerative potential of adult stem cells is already used in the treatment of more than 100 serious diseases, however, many people mistakenly believe that cell therapy is still a very new and little-studied area. But this is not the case, because the bone marrow and placenta, the richest sources of stem cells, were used to treat wounds yet by the Father of Medicine Hippocrates (5th century AD) and ancient warriors.

The impetus for the more rapid development of cell transplantation was the nuclear bombing of Hiroshima and Nagasaki in 1945, after which Japanese scientists sought effective means to restore the victims. And already in 1968 the first successful bone marrow transplant was performed, and this operation is nothing more than an intravenous injection of hematopoietic stem cells.

Today, hematopoietic stem cell transplant is the “gold standard” and the only method of treating a number of congenital and malignant blood diseases, including leukemia and lymphoma. Due to the complexity of selecting a compatible donor (probability of finding is from 1: 1,000 to 1: 1,000,000) and the traumatic procedure of bone marrow collection from the iliac bones, peripheral blood (after taking special drugs by the donor) or umbilical cord blood are increasingly used instead.

In 2006 and 2010, the European Blood and Marrow Transplant Group officially recognized umbilical cord blood as comparable to bone marrow as a source of hematopoietic stem cells. Therefore, the average unconscious opponent of cell therapy would never speak negatively about this extremely important direction in medicine, if they understood that when charities raise funds for leukemia patients to undergo bone marrow transplant abroad, it is the introduction of stem cells, ie cell therapy.

In-depth research on stem cell biology has shown that scientists can not only transform them into blood cells, other tissues and organs, but stem cells also secrete numerous biologically active substances (cytokines) that can treat inflammation, promote tissue growth or repair. This has led to the use of stem cells far beyond the treatment of blood diseases.

It is also worth noting that among stem cells there are dozens of species and populations, possessing different functions, and when introduced into the body – a different action. Thus, mesenchymal stem cells, which are especially abundant in the placenta, umbilical cord, umbilical cord blood, bone marrow have a pronounced anti-inflammatory effect, they are actively studied in the treatment of COVID-19. And hematopoietic stem cells give rise to blood cells: leukocytes, erythrocytes, platelets.

Thus, in addition to blood diseases in which stem cell transplant is a protocol method of treatment, cell therapy is used in clinical trials in the treatment of multiple sclerosis, Crohn’s disease, osteoarthritis, coronary heart disease, cardiomyopathy, liver cirrhosis, viral hepatitis C and COVID-19 etc.

Patients are often concerned about the safety of cell therapy, because stem cells are not sold in pharmacies, not every doctor is able to explain what the treatment is, and there are dozens of reports on complications from the illegal introduction of drugs under the brand “stem cells” in underground clinics, mainly for cosmetic purposes.

Therefore, we summarize the answers to the most common questions of patients about the safety of cell therapy.

Thus, complications from cell therapy may be as follows:

1) associated with the introduction of cells (intravenous, intra-articular, intracardiac, intrauterine, etc.);

2) associated with the side effects of cryoprotectants and other reagents used in cryopreservation of cells;

3) associated with the undesirable effects of the introduced cells themselves;

4) infectious complications from the introduction of a non-sterile drug.

Aseptic/antiseptic rules should be strictly followed to prevent injection complications, and the introduction of cells (especially into tissues) should be performed by an experienced professional.

To prevent complications related to the side effects of cryoprotectants and other reagents used in cryopreservation of cells, only cell preparations provided by a licensed Cryobank that has the necessary accreditations, experience of successful cell therapy, appropriate human resources should be used.

To avoid complications associated with adverse effects of the cells, cell therapy should be performed strictly according to the indications, if necessary, immunophenotyping or other biological tests between donor and recipient should be performed, an experienced physician should select the required cell population and dosage.

It has been proven that treatment with native (natural, unmanipulated) stem cells, in particular isolated from umbilical cord blood/peripheral blood or bone marrow, does not lead to tumors. Tumor diseases after introduction of early embryonic stem cells are described. There is a high concern about the possible tumor transformation of induced pluripotent stem cells (iPS-cells), which are not used in Ukraine. Cultivated or propagated stem cells should also be used with caution, especially if the Cryobank/Clinic has no experience in the production of cell drugs and successful therapy.

To prevent infectious complications that may occur with the administration of a non-sterile drug, cell therapy should be performed only with sterile grafts, although in some cases, when it comes to saving the life of a patient who does not have compatible donor biomaterial but has his own umbilical cord blood cells, which were non-sterile, they are allowed to be administered with the consent of the patient and adequate antibiotic therapy.

Thus, cell therapy will be a highly effective and safe method of treatment only if 2 requirements are met:

1) Cell material is processed by a licensed Cryobank in accordance with international standards.

2) Treatment is carried out on the basis of a licensed Clinic that has the appropriate permits, human resources and experience in cell therapy.

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