As stem cell treatment now continues to advance and become a regular option patients are relying on for relief from chronic conditions, the quality assurance of stem cell manufacturers and providers must remain at the highest level possible. Recently, a company called Athersys reported that they missed both outcome endpoints in a trial using the company’s mass manufactured stem cells to treat stroke. The breaking news is not that they failed to treat stroke patients, but rather that they were unable to manufacture quality cells after a certain number.
Stem cell providers, and thus stem cell treatment providers are not created equal. Beike Biotechnology has been manufacturing and culturing umbilical cord derived adult stem cells since 2005 with the highest quality control standards available, and are even accredited by the American Association of Blood Banks. For details regarding our accreditation visit our Quality page.
In disease protocols which require umbilical cord mesenchymal stem cells (UCMSC), the cells are expanded but only to a certain limit (P2 or P3) which also ensures that the cells retain their differentiation potential. In the case of Athersys, they expanded too far and the quality was negatively effected.
So what kind of questions should you ask when seeking stem cell treatment?
The following responses are the opinion of Beike Biotechnology and represent our cell therapy products and qualifications.
– Is stem cell treatment safe?
Safety is the most important parameter to take into account when you are looking for any medical treatment. The determining factors in cell therapy safety are usually the source of the stem cells, the laboratories they are produced in, and even the manner in which they are administered. Those will be addressed below. As for Beike’s adult stem cells, there have been no serious adverse reactions reported in over 20,000 applications, and adult stem cells are generally considered safe by the international medical community due to their limited differentiation potential. Other cell types may have adverse effects and those looking for stem cell treatment not utilizing adult stem cells should look into the treatment carefully.
– What is your stem cell source? Are they my own (autologous) or from someone else (allogenic)?
At Beike Biotechnology our adult stem cells are sourced from the donated umbilical cord blood of healthy mothers and babies from various partner hospitals around China. From there, our scientists are able to produce both umbilical cord mesenchymal stem cells, as well as umbilical cord blood stem cells (UCBSCs) in our Good Manufacturing Practice (GMP) standard laboratories. This source allows Beike to produce adult stem cells with specific differentiation potential in very large quantities – even more than 50 million cells per pack.
Umbilical cord blood and tissue are rich in stem cells as compared to other sources such as fat or bone-marrow and do not have the ethical or safety risks such as fetal, embryonic, or neural stem cells. Therefore worldwide these cell types are preferred for use clinically. However, it is equally important to consider where the cells are stored and processed.
– What accreditation and international certification does the company hold?
It is paramount that the stem cells come from a laboratory that has all required international certifications for its facility, its process and products. Beike Biotechnology has established more than 20 adult stem cell processing laboratories, in accordance with GMP standards, and has been awarded ISO9001 and ISO17025 certificates. Beike’s inspection center was accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in 2011, and it is the first adult stem cell processing laboratory accredited by the CNAS. Beike Biotechnology also successfully completed on-site evaluation for American Association of Blood Bank (AABB) accreditation in September 2011 and again in 2015. Beike is also a member of the International Society for Cellular Therapy (ISCT).
A dedicated quality control system should also be in place and a certificate from the laboratory should be requested with each treatment. For example, Beike is able to provide a quality control report for each stem cell packet produced guaranteeing the minimum accepted stem cell count, and can trace each individual packet to its donation source. As well, each production batch is sent to a third party government regulation facility as an additional safety and quality check.
Alongside this, the laboratory responsible for cell production should have have produced an official viability report detailing the necessary temperature environment and time constraints from production to application that will still adhere to their minimum acceptable cell viability requirements.
– What are stem cell passages and how many passages are used to culture your stem cells
Stem cell passages are the number of times a stem cell is divided before transplantation. When expanded too far, the cells lose their ability to differentiate into new cells. This of course means that their ability to treat illness is greatly reduced. Beike uses P0 for UCBSC (which means the original or primitive cells are used) and P2 or P3 for UCMSC. This ensures that patients get just right quantity of stem cells while keeping the maximum differentiation potential.
Adult stem cells have a limited differentiation potential and become less effective if multiplied many times in-vitro before transplantation. For example our stem cell treatment protocol regarding stroke patients calls for umbilical cord blood stem cells. With UCBSCs, only the primitive cells are used as we do not expand them before transplantation. This way, the stem cells have maximum potential to differentiate into specialized or targeted cells.
– How will the procedure work and what are the delivery methods?
Determine what the exact steps of the procedure will be. With allogenic stem cell treatment, the work is already done and the cells simply need to be produced for you and delivered.
There are a number of ways stem cells can be reintroduced into the body depending on the condition or area of the body being treated — IV, direct injection, retro-bulbar, lumbar puncture, etc. As an example, introducing cells directly into the wall of the heart has been shown to have the highest level of cell retention and can be seen in our recently published peer-reviewed paper on treating acute myocardial infarction.
It is important to make sure the physicians administering these treatments are not only qualified medical doctors in good standing, but also are experienced with stem cell therapy specifically and are aware of the expected treatment outcomes.
– What benefits should I expect to see?
Cell therapy for neurological, degenerative, or hepatic conditions is intended to repair and regenerate damaged tissues, organs, and nerve cells. Each person’s condition requires a different stem cell protocol. Stem cell therapy is not a “one size fits all” treatment.
The following is a brief explanation of stem cell mechanics in the body.
– Differentiation – The generation of new optic nerve cells, cartilage, bone, muscle tissue, etc.
– Angiogenesis – The stimulation of the growth of new blood vessels. Increased blood supply brings oxygen and nutrients to assist in the healing process.
– Anti-Inflammation – The reduction of inflammation is important as it is an underlying cause of most disease.
– Immune System Modulation – When the body is injured the immune system can overreact and attack the body. By ‘resetting’ the immune system the body can begin to repair itself again.
– Anti-Apoptosis – Prevention of further cell death in areas of damage in the body, as in chronic wounds, damaged nerves, diseased heart muscle, etc.
As noted before, not all stem cells are equal, and not all cell types work in the same manner. However, many thousands of patients have been treated for a variety of conditions using adult mesenchymal stem cells and cord blood stem cells with an unblemished record of safety and significant improvement in their condition and quality of life as can be seen in many peer-reviewed research papers.
It is important for the stem cell provider and physician to give you a realistic treatment expectation during the initial review and stem cell treatment should only be carried out if the physician believes there to be a positive chance of improvement.
– What is the research behind cell therapy? Is the provider the one doing the research or simply relying on third party data?
It can be difficult to absorb the technical aspects of cell therapy, but it is the job of your cell therapy provider to help you understand the clinical data and research which supports the therapy. It is also vital that those producing the cells are conducting clinical trials and are submitting papers for peer-review to ensure that their process and cells are a viable clinical option.
Beike’s renowned scientists have published more than 100 scientific case studies or reports. Some of these peer-reviewed papers have been featured in the most respected international medical journals and publications such as Nature and Time. The experience gained throughout this time is critical in providing a quality treatment option and should not be overlooked. To review Beike’s published studies refer to our research page.
– What is the cost of stem cell treatment?
The cost of adult stem cell therapy is an important factor, but not the only factor. Most stem cell treatment providers are not yet reimbursed by insurance companies, meaning they have made significant investments to make cell therapy available to patients outside of research trials in a safe, state-of-the-art clinical setting. First, determine the safety protocol, assess the overall standard of care from the cell processing equipment, medical team and center in which it is being delivered plus the expected benefits, and you should find that cell therapy is priced accordingly.
If the cost of therapy is outside of your budget, your insurance provider may be able to cover some of the costs associated with the stem cell treatment, such as physician counseling, injections, blood work, travel, accommodation, etc.
– Are there any supporting therapies, or does the treatment only include the stem cell injections?
Many treatment centers worldwide advocate stem cell treatment as a “quick fix” which is not always the case, especially for degenerative conditions. Due to the nature of stem cells and their mechanism of action, it is indeed vital for the patient to be in the best possible shape besides the condition which they are being treated for. For instance, a patient who has infection or areas of major inflammation in the body outside of the target condition should treat those symptoms before receiving stem cell treatment.
Many of Beike’s treatment protocols have been developed over the years to create a comprehensive treatment creating the best physiological environment to support the stem cells in the body. Some of these include nutrition, hyperbaric oxygen therapy, transcranial magnetic stimulation, and more all with the aim of improving treatment outcome.
– Is there any follow-up program involved?
Follow-up care once you are back home is an important part of treatment. Just as it is important to ask about the research and clinical trial data, it is also important to know whether or not the stem cell provider is reviewing their patients’ cases after they leave the center, and what this data shows about the efficacy of the treatment. At Beike, we have a dedicated Health Evaluation Survey that each patient should undergo pre-treatment and post-treatment to get an accurate assessment of the treatment outcome. Other centers may do this differently so it is important to ask.
While there are many more questions one can ask regarding cell therapy, production, and manufacturing, the above are a good start and will help you to make and educated decision. To find a treatment utilizing Beike’s adult stem cells and protocols you can visit Stem Cell Treatment Now