Frequently asked questions
WHAT IS REGENERATIVE MEDICINE?
In the world of orthopedics, Regenerative Medicine is a non-surgical treatment that allows your body’s own natural healing process to repair or regenerate injured tissues, which in turn can provide long-term relief from your pain. These minimally-invasive, non-pharmacologic therapies have been shown to be effective at treating acute and chronic injuries and have the potential to significantly improve your overall quality of life. For patients with arthritis, or those trying to return to an activity or sport, Regenerative Medicine is changing the game in orthopedic care.
ARE THE REGENERATIVE MEDINCE PROCEDURES SAFE?
Yes. Because the procedure is performed under sterile technique and with closed-loop sterile processing of tissue to ensure the highest level of safety. There is an extremely low risk of infection or immune reaction
IS THERE RESEARCH THAT SUPPORTS REGENERATIVE MEDICINE?
Yes. Although Regenerative Medicine is relatively new, there are thousands of published studies relating to this field of medicine, with hundreds of studies on the use of stem cells and PRP in orthopedics. Because of the positive results patients are experiencing, especially with regards to orthopedic conditions like arthritis, Regenerative Medicine continues to be a focus of intense interest amongst researchers
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.
WHAT IS THE DIFFERENT KIND OF STEM CELLS?
Stem cells are divided into 2 main forms. They are “Embryonic stem cells” and “Adult stem cells.”
Embryonic stem cells. The embryonic stem cells used in research today come from unused embryos. These result from an in vitro fertilization procedure. They are donated to science. These embryonic stem cells are pluripotent. This means that they can turn into more than one type of cell.
Adult stem cells. There are 2 types of adult stem cells. One type comes from fully developed tissues such as the brain, skin, and bone marrow. There are only small numbers of stem cells in these tissues. They are more likely to generate only certain types of cells. For example, a stem cell that comes from the liver will only make more liver cells.
The second type is induced pluripotent stem cells. These are adult stem cells that have been changed in a lab to be more like embryonic stem cells. Scientists first reported that human stem cells could be changed in this way in 2006. Induced pluripotent stem cells don't seem to be different from embryonic stem cells, but scientists have not yet found one that can develop every kind of cell and tissue.
Embryonic stem cells. The embryonic stem cells used in research today come from unused embryos. These result from an in vitro fertilization procedure. They are donated to science. These embryonic stem cells are pluripotent. This means that they can turn into more than one type of cell.
Adult stem cells. There are 2 types of adult stem cells. One type comes from fully developed tissues such as the brain, skin, and bone marrow. There are only small numbers of stem cells in these tissues. They are more likely to generate only certain types of cells. For example, a stem cell that comes from the liver will only make more liver cells.
The second type is induced pluripotent stem cells. These are adult stem cells that have been changed in a lab to be more like embryonic stem cells. Scientists first reported that human stem cells could be changed in this way in 2006. Induced pluripotent stem cells don't seem to be different from embryonic stem cells, but scientists have not yet found one that can develop every kind of cell and tissue.
WHAT ARE STEM CELLS MESENCHYMAL STEM CELLS, MSC?
They are cells located in the vascularized stroma of tissues more than nine weeks of gestation. Their name is due to the fact that when they were described it was inferred that they were remains of mesenchyme, an embryonic support tissue. They can be obtained from tissues as varied as bone marrow, adipose tissue, dental pulp, and umbilical cord.
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.
HOW DO STEM CELLS WORKS?
Stem cells are the very basic cells that have not yet decided what final tissue they will become. They can be found in tissues throughout the body and act as local “repairmen.” There are several different kinds of stem cells. Mesenchymal stem cells (MSCs) are the type that we use in orthopedic treatments.
MSCs have the strongest potential to repair musculoskeletal injuries. These cells have the ability to self-replicate, reduce inflammation, and differentiate (turn into) cartilage, bone, tendon, ligament, and muscle to help the body regenerate the lost or damaged tissue in the injured area.
We find that if these cells are placed in an injured environment, such as an arthritic knee, they are more likely to turn into the cells that the body needs. In the case of arthritis, the cells will recognize that there are cartilage injuries and help to repair the damaged cartilage. Stem cells also help to change the inflammation state of the knee, which not only helps rebuild cartilage, but makes the knee significantly less painful.
MSCs have the strongest potential to repair musculoskeletal injuries. These cells have the ability to self-replicate, reduce inflammation, and differentiate (turn into) cartilage, bone, tendon, ligament, and muscle to help the body regenerate the lost or damaged tissue in the injured area.
We find that if these cells are placed in an injured environment, such as an arthritic knee, they are more likely to turn into the cells that the body needs. In the case of arthritis, the cells will recognize that there are cartilage injuries and help to repair the damaged cartilage. Stem cells also help to change the inflammation state of the knee, which not only helps rebuild cartilage, but makes the knee significantly less painful.
ARE STEM CELLS REGULATED BY FDA?
Yes, the US Food and Drug Administration (FDA) regulates stem cell products and exosomes in the United States. The FDA requires manufacturers to undergo a review process that shows how their products will be manufactured and a license is required for distribution of these products.
DOES THE FDA REGULATE STEM CELL TREATMENT?
Yes, the FDA does regulate the use of human cells and tissues (including stem cells) through guidelines relating to the manipulation of the tissue. Because stem cell treatments are relatively new, there is currently only one stem cell treatment available that is FDA-approved, which we offer to our patients. In addition, other regenerative therapy options are available to our patients that are 100% FDA compliant and follow all FDA regulations and/or provide patients the opportunity to participate in a clinical trial (study)
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 MSCs 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.
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.
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-).
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.
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.
WHAT IS STEM CELL THERAPY?
Stem cell therapy involves guiding stem cells into becoming specific cells in the body. Stem cells are found in several places, including embryos, umbilical cords, and in adult bone marrow and fat.
In stem cell therapy, donor stem cells are placed in your body to replace and repair diseased cells. Stem cells grow and divide for a long time, so treatment gets your body started on the healing process, and then it continues to create healthier cells over time.
In stem cell therapy, donor stem cells are placed in your body to replace and repair diseased cells. Stem cells grow and divide for a long time, so treatment gets your body started on the healing process, and then it continues to create healthier cells over time.
WHAT IS EXOSOME THERAPY?
Unlike stem cell therapy, exosome therapy doesn’t involve using donor cells in your body. Instead, exosomes are extracted from donated human mesenchymal stem cells (MSCs) and sterilized. The exosome solution contains valuable lipids, messenger-RNA, micro-RNA, signaling cytokines, and proteins. Exosome therapy can be administered through intravenous (IV) therapy or direct injection in the treatment area.
Exosomes are powerful elements that can restore cells throughout your body. They enhance cell-to-cell communication, which is essential for overall cell health. Compared to adult stem cells, exosomes contain nearly three times the amount of growth factors. More growth factors mean a better ability to restore and revitalize target cells.
Exosomes are powerful elements that can restore cells throughout your body. They enhance cell-to-cell communication, which is essential for overall cell health. Compared to adult stem cells, exosomes contain nearly three times the amount of growth factors. More growth factors mean a better ability to restore and revitalize target cells.
WHAT IS DIFFERRENCE BETWEEN EXOSOMES AND STEM CELLS?
Stem cells are a special type of cell found in the body. They’re unique because they can become any type of cell, and they act as both building blocks and repair mechanisms in your body.
Exosomes are extracellular vesicles, which is the medical term for tiny bubbles that are released from stem cells. Exosomes carry genetic information and proteins to cells throughout your body, and they create paths for communication between cells.
Exosomes are extracellular vesicles, which is the medical term for tiny bubbles that are released from stem cells. Exosomes carry genetic information and proteins to cells throughout your body, and they create paths for communication between cells.
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.
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.
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