Frequently asked questions
WHAT ARE STEM CELLS?
Stem cells are cells with the capacity to multiply, which can also develop functional and structural characteristics specific to specialized tissues, including cartilage, tendons, muscles, and ligaments.
WHY ARE STEM CELLS USED AS A THERAPEUTIC TOOL?
Thanks to their capacity for multiplication and differentiation, it was inferred that they could replace lost cells due to diseases or degenerative conditions.
Clinical and preclinical experiments have shown that these cells also have an important ability to modulate inflammatory activity, induce neovascularization, modify the extracellular matrix, and modulate the immune response.
CAN ALL TYPES OF STEM CELLS BE USED FOR THERAPEUTIC PURPOSES?
No. Only adult or multipotent stem cells (hematopoietic or mesenchymal) are safe as a therapeutic tool, provided they are prepared and tested properly.
ARE STEM CELLS A SAFE THERAPEUTIC ALTERNATIVE?
Yes, as long as they are produced under appropriate conditions, by trained personnel, and following strict procedures in terms of quality and safety.
ADULT STEM CELLS SHOULD BE USED, ONLY AUTOLOGOUSLY (FROM SAME PATIENT)?
Adult hematopoietic or mesenchymal stem cells can be used autologously (produced from a tissue sample from the same patient) or allogeneically (produced from a tissue sample from another person). Mesenchymal stem cells do not express the major histocompatibility complex type II (HLA-DR), and although they slightly express type I (HLA-ABC), they do not express co-stimulatory molecules such as CD80 or CD86. Therefore, they are not subject to immune rejection.
WHAT ARE STEM CELLS MESENCHYMAL STEM CELLS, MSC?
Son células ubicadas en el estroma vascularizado de tejidos de más de nueve semanas de gestación. Su nombre se debe a que cuando se describieron se infirió que eran restos de mesénquima, un tejido de sostén embrionario. Se pueden obtener de tejidos tan variados como la médula ósea, el tejido adiposo, la pulpa dental y el cordón umbilical.
HOW THE USE OF THE MSC IS SUPPORTED PRODUCED FROM SAMPLES OF UMBILICAL CORD?
Perhaps the most commonly used tissue source for obtaining and producing mesenchymal stem cells is the umbilical cord, since the genomic stability and metabolic well-being of cells cultured from these tissue samples has been demonstrated. In addition, the donor can be properly evaluated to rule out infectious diseases, and an adequate review of personal and family medical history can be conducted.
WHY ARE MSC USED, FOR THE MANAGEMENT OF DEGENERATIVE DISEASES SUCH AS OSTEOARTHRITIS, DIABETES AND ALZHAIMER’S DISEASE?
Through different mechanisms, including the control of inflammation, the formation of new blood vessels, the activation of local cells, modulation of the immune response, and the substitution of lost cells in the tissue, these cells induce the regeneration of a wide range of diseased tissues, as well as decrease their inflammation and recover adjacent structures. Therefore, they can lead to a significant and lasting reduction in symptoms.
WHAT DISEASES OR CONDITIONS OF THE JOINTS, BONES, OR MUSCLES, COULD BE TREATED WITH CELLS MOTHER?
The list is very broad and varied. It includes sports injuries and general traumas, as well as long-term illnesses that affect large joints such as the knee, hip, and shoulder, long bones such as those in the legs and arms, muscles, tendons, and ligaments.
WHAT ANOTHER TYPE OF DISEASES OR HEALTH CONDITIONS MAY BE TREATED WITH STEM CELLS ADULTS?
Autoimmune diseases, respiratory and kidney problems, and all those due to age-related deterioration.
- Significantly lower mortality (at 28 days) in the intervened group (7.6% vs 21.5%).
- Significantly superior clinical improvement in the intervened group.
- There was no difference in the risk of adverse events between the groups.
HOW DO THE MSC APPLY TO THE PATIENT?
It depends on each patient’s characteristics, and different factors come into play, including their disease and its severity. They are usually applied directly to the affected area, although intravenous use is also common considering the benefit they can generate throughout the body.
ALL PATIENTS CAN RECEIVE TREATMENTS WITH MSC?
No. It should be understood that stem cells have an enormous capacity to stimulate the growth of other cells in different tissues. Therefore, a patient with an active cancerous process could worsen, since stem cells could stimulate tumor cells and make the cancerous mass grow.
WHAT CHARACTERISTICS MUST HAVE A MSC PRODUCTION PROTOCOL FOR COMPLY WITH GOOD PRACTICES OF MANUFACTURING (BPM)?
In order for a protocol to comply with the parameters of Good Manufacturing Practices (GMP), verification and control mechanisms for all raw materials, materials, and reagents used during the production process must be established to ensure the absence of external contaminants that could cause cross-contamination and, consequently, pose a risk of product rejection by the patient (user).
HOW CAN YOU DEMONSTRATE THE SAFETY AND SUITABILITY OF MSC AS THERAPEUTIC TOOL?
The expansion of MSCs is an in vitro process in which conditions are established to promote cell growth and, consequently, the growth of other unwanted biological agents, such as microorganisms.
Therefore, to demonstrate the safety and suitability of MSCs, microbiological, cytogenetic, and phenotypic requirements must be defined and evaluated through laboratory techniques to demonstrate compliance.
WHAT POLLUTANTS ARE? ALLOWED IN OUR PRODUCTS?
No microbial agent is allowed in either the raw material or the final product. To ensure this, human tissues used as raw materials are screened for the presence of viral, bacterial, and fungal agents.
The same applies to the cells ready to be used (final product), which are evaluated using different laboratory techniques to demonstrate the absence of bacteria, fungi, yeasts, Mycoplasma sp., as well as the absence of toxic substances produced by bacteria, such as Endotoxins.
HOW SAFETY AND SAFETY ARE DEMONSTRATED SUITABILITY OF THE CELLS?
The safety of the cells is demonstrated through the analysis of their karyotype, which shows their genomic normality.
The suitability of the cells is demonstrated through the expression of the markers typically recognized for MSCs by the International Society for Cellular Therapy. These markers must be expressed in at least 95% of positive cases (CD73+, CD90+ and CD105+) and should not exceed 5% in negative cases (CD34- and CD45-).
IS THERE ANY ALTERNATIVE TO IMPROVE THE RESULT OF TREATMENT WITH STEM CELLS?
Yes. On some occasions, we use growth factors from the patient themselves, which are purified under the strictest conditions of sterility, to best utilize their therapeutic capabilities and enhance the effect of the cells.
WHAT ARE THE POSSIBLE SIDE EFFECTS? OF THE USE OF THESE CELLS?
Actually, they are very rare and insignificant. Patients may experience fever, redness, and spasms at the site of application, which disappear within a couple of days with simple treatment.
WHAT IS TRUSTEM?
Trustem is a biotechnological laboratory focused on developing advanced medical therapy alternatives for regenerative medicine, implementing technology and knowledge developed over 10 years of work, with scientific and academic support from the University Fundación Universitaria de Ciencias de la Salud FUCS.
WHAT IS MULTIPLICATION? WE MAKE CELLS?
To cultivate cells under suitable conditions, through the execution of internationally developed and validated protocols by us in a specialized laboratory designed and equipped for this purpose, with the aim of maximizing the therapeutic capacity of stem cells.
WHAT EXPERIENCE DO WE HAVE IN THE USE OF THESE CELLS?
Trustem was created with the aim of enabling access to advanced medical therapy alternatives.
Our team is composed of health science professionals, with master’s and doctoral level training. We have accumulated more than 30 years of experience in the development and implementation of advanced medical therapy alternatives for regenerative medicine. Our knowledge and experience allow us to provide technical and disciplinary support in the standardization and implementation of therapeutic protocols using these therapeutic tools. We have experience in the management of different diseases, conditions, and injuries, including those that affect the nervous, cardiovascular, pulmonary, and musculoskeletal systems, in people of different characteristics, including high-performance athletes.
WHAT ARE THE SECRETION VESICLES? EXTRACELLULAR VESICLES?
Extracellular vesicles are lipid bilayer structures secreted into the extracellular environment by most of our cells. These vesicles can be divided into three categories based on their size: exosomes, microvesicles, and apoptotic bodies.
WHERE ARE EXOSOMES PRODUCED AND WHY DO THEY HAVE THERAPEUTIC INTEREST?
Exosomes are produced in the Golgi apparatus and the rough endoplasmic reticulum through a process of directed evagination and loading of specific molecules. In the case of MSCs, these molecules are directly related to their trophic capacity and therapeutic potential.
EXOSOMES ARE AN ALTERNATIVE SUBSTITUTE FOR STEM CELLS?
No. They are complementary alternatives, and frequently both are used as part of therapeutic protocols. Both alternatives are for parenteral use, however, exosomes can also be nebulized. For their management, technical and logistical conditions that are much simpler than those of cells are required.
THERE ARE SOME APPLICATIONS EXCLUSIVE TO EXOSOMES?
No. Exosomes are not exclusive to:
✓ Aesthetic medicine
✓ Management of skeletal muscle injuries
✓ Management of pulmonary problems through nebulization.
HOW EXOSOMES ARE APPLIED PRODUCED BY THE MSC?
It depends on the characteristics of each patient and several factors come into play, including, of course, the disease and its severity. Typically, they are applied directly to the affected area, although intravenous use is also common considering the benefits they can generate throughout the body.
ALL PATIENTS CAN RECEIVE TREATMENTS WITH EXOSOMES PRODUCED BY THE MSC?
No. It should be understood that stem cells (and their exosomes) have an enormous capacity to stimulate the growth of other cells in different tissues. Therefore, a patient with an active cancerous process could worsen, since MSC exosomes could stimulate tumor cells and make the cancerous mass grow.
WHAT CHARACTERISTICS MUST HAVE A EXOSOME PRODUCTION PROTOCOL TO COMPLY WITH GOOD PRACTICES OF MANUFACTURING (BPM)?
In order for a protocol to be executed within the parameters of GMP (Good Manufacturing Practices), mechanisms for verification and control of all raw materials, materials, and reagents used during the production process must be established to guarantee the absence of external contaminants that may cause cross-contamination and, therefore, constitute a risk of product rejection by the patient (user).
The production process must be carried out in suitable facilities equipped with appropriate equipment for the manufacture of advanced medical therapy products.
The final product must be analyzed prior to its release for clinical use in order to verify its quality, suitability, and safety for the patient.
HOW CAN YOU DEMONSTRATE THE SAFETY AND SUITABILITY OF EXOSOMES PRODUCED BY THE MSC?
The expansion of MSCs is an in-vitro process in which conditions are established to favor cell growth and therefore, the growth of other unwanted biological agents such as microorganisms.
Therefore, to demonstrate the safety and suitability of exosomes as well as their MSC-producing cells, microbiological, cytogenetic, and phenotypic requirements must be defined and evaluated using laboratory techniques to demonstrate compliance.
WHAT POLLUTANTS ARE? ALLOWED IN OUR EXOSOMES?
No microbiological agent is allowed either in the raw material or in the final product. Therefore, in human tissues used as raw material, the presence of viral, bacterial, and fungal agents is ruled out.
The same applies to the exosomes ready for use (final product), which are evaluated using different laboratory techniques to demonstrate the absence of bacteria, fungi, yeast, Mycoplasma sp., as well as the absence of toxic substances produced by bacteria, such as endotoxins.
HOW SAFETY AND SAFETY ARE DEMONSTRATED SUITABILITY OF EXOSOMES?
The safety of exosomes is demonstrated through the analysis of the karyotype of the cells that produce them. This way, their genomic normality is demonstrated.
The suitability is demonstrated through:
Characterization by Nanotracking, where their shape, size, and appropriate concentration are evaluated.
The expression of the markers normally recognized for MSCs by the International Society for Cellular Therapy. These markers must be expressed at least 95% for the positive markers (CD73+, CD90+, and CD105+) and must not exceed 5% for the negative markers (CD34- and CD45-).
IS THERE ANY ALTERNATIVE TO IMPROVE THE RESULT OF TREATMENT WITH EXOSOMES PRODUCED BY THE MSC?
Yes. On some occasions, we combine them with growth factors from the same patient, which are purified under the strictest conditions of sterility to make the best use of their therapeutic capacities and enhance the effect of the exosomes
WHAT ARE THE POSSIBLE SIDE EFFECTS? OF THE USE OF THESE EXOSOMES?
In reality, they are very rare and insignificant. Some patients may experience fever, redness, and spasms at the site of application, which disappear within a couple of days with simple treatment.
