High Hopes for Nascent Stem Cell Therapy IndustryWed, 09/09/2015 - 14:26
Q: What have been the highlights of ReHealth Regenerative Therapies’ activities since its creation?
A: Stem cell therapy is still a nascent field in Mexico with great expectations for the next five years. ReHealth Regenerative Therapies (ReHealth) was created in partnership with DaVinci Biosciences, based in Costa Mesa California, with the aim of providing storage, commercialization, and implantation of stem cells for patients with cardiovascular diseases and sports injuries in Mexico. We receive full technical and scientific support from DaVinci Biosciences, which has recognized Mexico’s potential and capabilities in the medical and scientific fields. Nevertheless, bigger investments are needed in this country. For instance, stem cells can be extracted from bone marrow, quantified, and visualized in our laboratory, but replicating them remains a challenge that requires sophisticated technology. For the time being, we export bone marrow stem cells to The BioBox, an affiliate of DaVinci Biosciences for storage and cryopreservation in hopes that if needed at a later date patients can use these rather than having another procedure done. We are in the works of replicating DaVinci’s technology in Mexico. This system will allow us to work in the cardiovascular, lung, orthopedics, traumatology, and diabetes areas, but we have plans to also cover autoimmune diseases. We plan on commencing a fully funded clinical study once all appropriate regulatory approvals are in place. In addition, as part of the DaVinci Biosciences’ family of companies, DV Biologics sells and supplies different types of human cells to biotechnology and pharma companies engaged in drug discovery and development.
Q: What are the most important barriers to producing and commercializing stem cells in Mexico?
A: Stem cell research is fascinating and many research groups around the world are busy advancing knowledge in this field. Nevertheless, their therapeutic application is rather new and limited to certain hospitals and clinics in developed countries. There are many diseases that could be treated with stem cells, but the medical community is very careful not to prescribe them without sufficient medical evidence about their efficacy and safety. In addition, more education is needed for patients, physicians, and COFEPRIS. Stem cell therapy requires physicians to do a proper evaluation and follow-up with patients. Furthermore, there is still a lot of misinformation about this field, many people think stem cells are miraculous and can cure any condition. This leads them to pay up to US$80,000 to receive stem cells in hopes that their condition will be cured. Several of our patients have done this abroad and we have had to explain to them that this was an unethical, unprofessional service. We then explain to them that stem cells may possibly improve their quality of life. We explain to them the properties of stem cells that may help in their condition and they are ultimately very satisfied with the explanation and service we provide. Alongside this, we have someone dedicated to visiting and training physicians to explain the scientific background and medical results of stem cells, since most doctors are not familiar with them, which is a barrier to expand access to this treatment. Regarding the technical and infrastructural aspects of stem cell therapy, Mexico has many brilliant scientists that are perfectly capable of doing research and developing competitive technologies. However, more investment is necessary to acquire specialized technology and infrastructure. For instance, we would like to have a laboratory with DaVinci Biosciences equipment, however, access to funding is harder and takes longer in Mexico, which delays the development of new services that cover specific needs in the market. We are also looking for the same equipment and supplies being used in California but, despite everything being available in Mexico, these are all being manufactured abroad. As for clinical trials, conducting a formal study protocol is very costly and can easily reach in excess of US$500,000 in Mexico, with the insurance alone to cover the study costing US$30,000-40,000 and this is only for a small number of patients. Mexican scientists are thus prevented from advancing promising lines of research. However, ReHealth is taking small but solid steps in each of these aspects and continued effort will consolidate our position in the healthcare industry.
Q: Many patients have their eye on countries like Mexico for cheaper medical treatments. Do you have any plans to join the hospitals already profiting from medical tourism?
A: Between 60-70% of our patients are from the US and Canada, who come to Guadalajara to receive our stem cell therapy. However, while patients come to this city for particular treatments or physicians, medical tourism in Guadalajara has not received a lot of attention yet. In order to strengthen our presence abroad, we attend major networking and academic events, such as the Annual World Congress on Anti-Aging Medicine in Las Vegas, where we explain who we are and what we can do for patients. While many are unsure about coming to Mexico, we are making headway and to help speed this process up we need to generate agreements with clinics, laboratories, and hotels to offer complete medical tourism services for our patients. Patients often tell us what kind of tests they need ahead of time so we can help them find the right diagnostic clinics and physicians in Guadalajara, which goes a long way toward helping them to better plan their stays. Finally, there is a significant American and Canadian community of retired people based near Chapala Lake in Jalisco, from where many people come to us looking for treatment for various ailments.
Q: You have already mentioned the ongoing research on stem cells therapy, but what is your contribution to this field and are you conducting clinical trials in Mexico?
A: In the beginning, we were interested in extracting stem cells from bone marrow and inserting them into the heart. We then started using these for spinal cord injuries and multiple sclerosis with very interesting results. We are now commencing with five clinical studies on stem cells’ safety for cardiovascular and rheumatoid arthritis through a CRO that manages all these trials. In addition, we are very interested in stem cells and their effect on aging. There is research that suggests stem cells can prevent the shortening process of cells’ telomeres to a certain degree, slowing down aging. Telomeres are the tails of chromosomes that become shorter with every cell division, determining the life span of the cells. This research line received a Nobel Prize some years ago, but the only laboratory that is currently able to measure telomeres the correct way is based in Spain. This research group in Spain is investigating the effects of diet, exercise, and other lifestyle factors on the length of cells’ telomeres. Other physicians are using stem cells for other issues such as articulations, sports injuries, diabetes, and inflammatory diseases. We are also very interested in generating important data regarding their efficacy for chronic and degenerative diseases, such as Alzheimer’s and Parkinson’s. Unfortunately, brain diseases are still very risky to deal with because the cells have to go inside the brain, and no sustained therapeutic effect has been detected as of now. Stem cells are immune regulators with anti-inflammatory abilities. They can create new blood vessels in a process called angiogenesis. As scientists, we need to be able to objectively measure all of the benefits; while remaining focused on the therapeutic effect we are investigating to truly improve quality of life.