Regenerating Tissue With Mexican Stem Cell DevelopmentBy Miriam Bello | Mon, 10/05/2020 - 14:38
Q: How is Exomelab innovating in patient care and treatment in the field of regenerative therapy?
A: Despite being a new company in the market, our expertise as a research team began around 1997 in the field of cells, organs and tissue transplantation. We began generating biotechnological platforms for isolating mesenchymal stem cells and as a result of these efforts, we decided to create this company. Through our research discoveries, we generated information on how stem cells can help the organism to renew cells in organs and tissues afflicted by any chronic degenerative disease.
Mesenchymal stem cells can be isolated from many tissue sources, such as bone marrow, adipose tissue, body fat, endometrial tissue, and from embryonic attachments, such as placenta, the amniotic membrane and the umbilical cord. Endometrial tissue was the most important source for our studies. Women eliminate great quantities of stem cells per month through menstruation. Gemlabs laboratory has patented a device that isolates the menstrual flow from the first two days of the period to recover stem cells. Through an in vitro process, we are able to obtain millions of stem cells and bioactive elements from these cells, including exosomes and microvesicles. After isolating all these molecules, we combine them through tissue engineering into a biological scaffolding of collagen and calcium alginate that results in a patch that can be used on any damaged tissue.
As we grew as a company, I started to specialize my research in Type II diabetes mellitus, specifically on diabetic foot as a result of a vascular tissue failure that causes sores that can even lead to the loss of a foot. We saw a great opportunity for mesenchymal stem cells to regenerate damaged tissue in patients suffering from diabetic foot. The patch stimulates the regeneration of tissue because it allows a process of revascularization, meaning the creation of new blood vessels and arteries. Moreover, this patch allows the wound to regenerate completely, meaning that it can even grow back hair, regenerate sweat and sebaceous glands. It also regenerates the nervous system, which allows a return of sensitivity. This patch prevents the formation of a scar or a fibrotic tissue. We started preclinical trials at PEMEX’s hospital and in 2019 we received the patent for this level three device development and also its sanitary registration with COFEPRIS.
The patch can act on any damaged tissue, independently of the person’s healthcare background. This regenerative process is an unprecedented development because of the quality of the final result. Neither scientists nor doctors are used to seeing a healing process that does not create fibrotic scars but truly regenerates the tissue from within.
Q: Which COFEPRIS approval processes were necessary to commercialize your products?
A: The Mexican market is plagued by charlatanism and introducing a level three development requires a long and complex process to ensure that the product is 100 percent safe. COFEPRIS is still pretty young and expands according to the new innovations brought by Mexican developers. However, this does not happen often. There have been significant advances in the regulation of stem cells but we are still missing a general norm on the subject that includes cells, tissue and genetic therapies. These regulations already exist in the US and Europe, which provides us with guidelines as these countries have marketed many therapies in the past 10 years. I would not consider the stem cell market young because its development and regulation have been strengthening for 20 years.
Despite COFEPRIS’ young experience in the field, it has strict requirements. The commission provides the sanitary registration for the use of stem cells in Mexico to those who comply with three licenses: procurement of source tissue, stem or progenitor cell storage bank and regenerative medicine. However, we do expect to see stronger regulations regarding quality control frameworks for the production of stem cell systems because we know how delicate and complex this process is. Mexico already has 20 laboratories working with mesenchymal stem cells and they all need to be working under the same guidelines and quality criteria.
Q: The FDA approved a clinical trial of mesenchymal stem cells to treat COVID-19. How can Exomelab use its expertise to exploit this possible solution?
A: Exomelab has been working on a protocol for the application of mesenchymal stem cells on the treatment of viral sepsis caused by the SARS-CoV-2 virus. We submitted this protocol to CONACYT and the results will determine if they will support the initiative.
The importance of stem cells is in how they can help the lungs in the immunomodulation process. COVID-19’s severe damage to the respiratory system destroys many healthy cells within the body and this worsens in people suffering from any chronic disease, such as diabetes or obesity. One of the molecules that the virus uses to enter the body is the angiotensin receptor 2, which is the antagonist of molecule ASR that is related to the construction of blood vessels. Combined with a molecule that dilates the vein, this results in a massive impact on the human body as it inflates the system and compromises the respiratory system.
Chinese research has shown that the use of three mesenchymal stem cell doses of 50 million each applied on days one, three and nine, allowed patients to overcome the most critical stages of COVID-19 within days.
Q: What are Exomelab’s near-term goals?
A: Exomelab is working on the commercialization of our device through the brand Skin Care Exocell owned by Laboratorios GEM. We are also working on the creation of the International Society of Exosome-Based Medicine, which is developing quickly as it has attracted a great deal of attention and gathered important actors from many parts of the world. The idea of this society is to create a professional scientific forum to organize congresses and courses that encourage the use and development of exosome-based therapies.
Exomelab applies biotechnological innovation to treatments using advanced regenerative therapies with mesenchymal stem cells and exosomes to promote the regeneration of damaged tissue