Written by Dr. Matias Fernandez Viña – MP 64.620
Medical Director At Stem Cell Therapy, Argentina
Many times, we hear people claim that regenerative medicine is ineffective or a scam, since a friend of an acquaintance was applied to a treatment that was not.
Why take the time to read this?
If you are a Patient, or even a Physician who does not work in Regenerative Medicine, but that this is of interest to you, you should know that, in principle, the Regenerative Medicine NO it is a Medical specialty, nor are there specialists in Understanding Stem Cell Therapy or PRP.
At the university, we work daily to enhance the academic standards of regenerative medicine but for now “There are No Specialists in Regenerative Medicine, and if that tells you a professional, have to take it with great caution” but still known to this area.
Usually we see patients who are scammed receiving illusions of institutions in medical that offer miraculous therapies using products derived from cells by a “Medical Specialist in Stem Cells” as if it were a specialty of Medicine like Cardiology, Orthopedics, Dermatology, etc
We have an epidemic of scams “Institutional” of stem cells not only at the national level, but globally. This leads to discredit the field of Regenerative Medicine and Cell Therapy procedures are poorly made and Physicians that you just take a weekend course and they are named specialists in Stem Cells.
Then, how can you make sure you get something real and not fake?
If you want to make sure you are not being scammed by those who are not legitimate in the institutions, you must answer these simple questions:
1. What are you going to inject?
2. How and where to split the cells? What is done in a simple office with laminar flow, or in a clinic enabled for medical practices according to the standards of Biosecurity and preparedness?
3. Who will do the procedure?
4. When it works and doesn't work?
5. In what environment you are going to inject? What is done in a doctor's office or a Room Sterile set for this practice?
6. How are they going to perform the procedure?
7. What is the counting of Cells, or Platelets applied?
1. What are you going to inject? What products are regenerative or ortobiológicos?
Are substances that can be autologous (from the patient) or allogeneic (from another patient) and inject to speed the healing or to allow for the regeneration of tissues orthopedic. This includes derivatives such as platelet-rich plasma and stem cells mainly.
2. How and where to split the cells?
What is done in a simple office with laminar flow, or in a clinic enabled for medical practices according to the standards of Biosecurity and preparation?
Serious error that made those people are not trained properly in Regenerative Medicine is the separation of biological products to be applied in a joint or in the soft tissue, for example, within a medical office.
In addition to being a site is usually not enabled by the Colleges of Biochemical according to the law which establishes, to obtain the products and process, these are physical sites where you do not meet the criteria for biosafety. Exactly that's why they are called "Office", to perform medical consultations, not applications or procedures.
Many professionals demonstrate that perhaps by having low-cost technologies, such as physical barriers of biosecurity are sterile gloves, or laminar flow cabinets, this is what they have resolved.
Unfortunately, happens as well. To correctly apply the Regenerative Medicine, the collection and separation of Cells or Concentrated with Platelets should be in places where biosecurity is guaranteed, as for example, rooms prepared for the extraction and processing areas specific, such as a Laboratory, with showers of air, air-to-positive pressure in the room, booths, laminar flow biological safety, and ultra-violet light for the rest of the room pre-and post-processing.
The only way to accomplish this in the same place, is by using a closed system processing, where the product NEVER have contact with the outside.
3. Who will do the procedure?
The procedure should be performed by a physician trained in the field of tissue regeneration. The Doctor does not only should know the anatomy or be used to make apps with injections, but to understand the key point of applying the product, regenerative to trigger the answers that you seek to obtain. To understand these mechanisms, we are talking about essential bases for molecular regeneration of a structure to articulate. In addition, the Physician must understand what it applies to and what is the response of the biological product that will have week after week, in compliance with the phases of inflammation, proliferation, and regeneration.
4. When it works and doesn't work?
The most important part of the medicine is knowing when to use what treatment and when not to use it. This last part is very critical and important, as not all are candidates for the application of Regenerative Medicine.The same has contraindications, which must be understood correctly.
Apply a product regenerative autologous, it is not a guarantee that you are ALWAYS able to operate. To know the correct procedure should be to know and analyse data correctly to the patient.
There are pathologies that have a lesser or greater response and depends very much on the degree of progress. Knowing these data, the pathophysiology and the ability of the product regenerative to know if I could work out or not is essential. Example, our analysis of follow-up data showed that older patients who have artosis knee grade III-IV, our procedure of mesenchymal cells in the same day may help to prevent a knee replacement and to improve the quality of life in a 67%.
5. In what environment you are going to inject? How doctor's office or a Room Sterile set for this practice?
It is very important that at the time of performing a procedure of Regenerative Medicine, the physician that you apply this treatment, know that the same shall be in rooms conditional specific and not in a doctor's office, care scheduled patients.The biosafety of these therapies should be a guarantee, complying with the international requirements and care even in the clothes of the medical attendant.
There are many professionals currently used by the cellular therapies without barbijos, gloves with nitrile non-sterile, without bonnet and camisolin, whether products containing the cells or platelet-rich plasma, without correctly identifying the damage that can result when they are applied in a doctor's office of health care.
Many products are processed and separated in the office, with or without laminar flow cabinet, believing that the biosafety environmental assured, when it is not so. The positive pressure of the living room is very important to prevent the air from becoming contaminated and renew filtradamente.
The products regenerative should be applied in any rooms sterile or conditioned to these practices. The processing of these products, they must be performed in environments or areas enabled specifically by the regulators, and compliance in addition to international standards suggested, therefore, generally it is suggested to be applied in a Clinical setting, where, in addition you can answer the Medical complications that may exist. Many doctors use the forms to separate these products, so closed, ensuring the biosafety of the team, but clearly these products should be placed in sites where the sterility exists.
6. How are they going to perform the procedure?
It is important that the Medical Professional will explain how it will be throughout the procedure. From the collection and removal of the source of the product, until the application of the same. It is also important to know if the procedure is under anesthesia, or if the cellular product contains already anesthesia. We see very frequently in the videos broadcast to the public through social networks, the application of products for regenerative with anesthesia in the same syringe, where the cell cytotoxicity is closely related to the products, regenerative.
7. What is the counting of Cells, or Platelets applied?
You have to be very clear that a Doctor will apply a product regenerative and not give her the cell count of the product, whether cells mesenchymal cells total nucleated from the bone marrow, cells of the fraction stromal fat or the platelet-rich plasma, clearly, he has made a therapy that does not know what he has posted.
The importance of the metering cell is key and is what allows you to know the position terapeutica that will have the doctor and the patient.
The metering cell can be performed very easily by a trained staff, the problem is that many people don't know how to do because they are not trained.
Your time, not only it is recommended that a cell count, but that recommend testing of the products to see if they are products with living cells, whether they could be contaminated, and this can be done with very simple techniques.
In conclusion... we begin to understand why in Argentina and also in Latin america, the good practices of Regenerative Medicine are important and the key to the proper development of the same and that there are therapies that are labeled as fraudulent or miraculous.
In turn, the specialists in Stem Cells, or cell Therapy, or Regenerative Medicine, do not exist or are legally guaranteed.
If there are professionals linked to the Molecular Biology, Physiology, Cellular, Hemoterapistas or as Specialists in Rehabilitation, or Trauma, that would be the that might be intimately related to these regenerative therapies.
Those Doctors who perform Regenerative Medicine and have the academic endorsement or scientific evidence to back it, can be called "Experts in Regenerative Medicine and Cell Therapy."
