There has been a lot of scrutiny from both the FDA and the general public on the stem cell industry as of late. The FDA has been bringing down the hammer on many stem cell businesses around the United States. There is a bit of confusion on what is going wrong and how stem cell businesses are missing the mark.
We are here to sort out this entire mess and get to the bottom of what is really going on. We have done the necessary research to sort out the frauds from the real stem cell companies that are offering therapeutic treatments. Let’s go back to the beginning to see what really happened with the stem cell industry.
After regulations were loosened the stem cell industry became a sort of wild west. There were many easy ways to get around the FDA regulations and companies could make all sorts of outrageous claims. Plenty of companies wanted in on the endless therapeutic potential that stem cells present. Many of them did not always have the science or understanding to back up their claims. But, the growth of stem cell clinics and companies has continued.
The stem cell industry is currently in a phase of rapid expansion. By some estimates there may be as more than 1,000 stem cell clinics operating in the United States. That number is likely to grow in the next few years as stem cells continue to be easily accessible to any medical professional looking to open their own clinic.
Just like with other industries that experience rapid growth, there are bound to be a number of companies that are fake. Think of the current eCigarette market. There has been a huge market that was created in just the last few years. The product is extremely attractive to those looking to quit cigarette smoking and for young people in general. Many eCigarette companies claim that their products are completely harmless besides the addictive properties of nicotine.
Many vaping products are skirting around the edges of regulation, just like many stem cell clinics are in the United States. They are more concerned with profit margins than the safety of their customers or patients. Just in the past few months multiple people have died and hundreds of people have gotten ill from vaping related illnesses. The illness problem is not unique to the vaping industry.
One company, Genetech, had a problem with how they were manufacturing the products from umbilical cord blood. The FDA sent them a warning letter detailing what they were doing wrong. 12 patients actually had to be hospitalized after they were treated with stem cell products from Genetech. They still have not corrected their problems as of today.
The worst part is that stem cell clinics were allowed to get into compliance with FDA regulations and there were no penalties involved. The fact that they were so bold as to completely ignore regulations and do things the wrong way is deeply disturbing. Companies are bound to keep failing and restricted if they do not get their operations and businesses in check.
These companies continue to be a culprit in the American people’s distrust of stem cell procedures and therapy. They may be simply uneducated in how stem cells really work or worse, they may be taking a novel therapy and tricking the uneducated into using stem cell treatments that do no work.
Another big issue is that many medical practices like to add stem cell therapy as a procedure. They see it as a buzzword like CBD oil is for the marijuana industry. They just want to put it on their website and offer it as a therapy in order to attract more patients. There is no real interest for them to improve stem cell therapy.
Based on a study of stem cell businesses in the southwest, only 25% of businesses that offered stem cells were solely focused on stem cells. To add even more context, about one-third of the stem cell businesses shared a physical address with another medical or cosmetic clinic. This is further evidence that many stem cell companies are not even focused on stem cells.
This is a problem for a wide variety of reasons. These stem cell businesses may not have the correct stem cells for your unique issues. They also may not have the right equipment. The medical professionals at the ‘stem cell clinic’ do not have the proper training or certifications in order to administer stem cell therapy. There are also stem cell companies that are not interested in treating patients, they are interested in creating therapies where they can make the most money.
In it for the Wrong Reasons
Stem cell startup companies are being founded all over the place in the United States. Some of them do have legitimate research and drug development business models, but many more are in it for a quick buck. Some of these stem cell startup companies are raising unbelievable amounts of money to try and break into the stem cell market.
One company raised $250 million last year to explore using placenta based stem cells to treat a wide variety of issues. The problem is when these organizations bring a therapy to market then they will surely charge and arm and a leg for it. Many stem cell researchers are looking to create affordable and sustainable treatment methods. Yet, there are still more companies that are looking to swindle the uninformed.
Several stem cell manufacturers claim that they produce stem cell products. They claim that their amniotic or umbilical cord stem cell products will produce the therapeutic effects that stem cells are known for. Several studies have actually shown that the products they produce are completely fake. The stem cells are supposed to be thriving and living, but in reality they were dead. They have been selling fake products and promising hope to patients.
It really is such a shame that so many organizations would pose as legitimate companies selling a real product. They are no better than the snake oil salesmen back in the old west. Some other companies are using shady sales tactics to get to customers and convince them to get their stem cell treatments.
Forced into Stem Cell Therapy
Regenexx is one of the largest and oldest players in the stem cell industry in the United States. They have been in the game for a long time and they know how to play the system.
They have actually gone around insurance providers and have started going straight to employers. Regenexx claims that employers will be able to save thousands of dollars each year by using their stem cell therapy treatments. In a marketing brochure they also claimed that 70% of orthopedic surgery can be replaced with stem cell therapy. There is absolutely nothing to back up their claims. They have convinced some rather large companies to include their treatments in their employee health insurance plans. This is a shady business practice as employees never have a say in the health insurance plans and procedures that they are given.
Employers will make employees use stem cell treatments before they pursue other treatments, such as surgery. Employers should not have a say in exactly which treatment their employees receive. Some patients could have a moral objection to the treatment, which is perfectly acceptable. No patient should be forced to complete a treatment they do not want to. Plus, Regenexx may actually be recommending stem cell therapy to patients where stem cell treatments are not the best option.
We do it differently
We only create treatment plans that will help the pain or disease that a patient is currently experiencing. Evert treatment plan is completely unique to the patient and their condition. There is no one-size-fits-all stem cell treatment for patients, every case needs to be handled differently. Stem cells do not actually always work for every patient as well.
There have been several instances where patients are evaluated by our medical staff and we have told them that stem cell therapy would not work for their case. We have had to tell them that surgery is the only option for them sadly.
For example, Jason Ellis, the famous professional skater and Sirius XM host, visited the BioXcellerator stem clinic in Medellin, Colombia. Jason received umbilical stem cells and platelet-rich plasma (PRP) in both of his knees, his left ankle, and his left shoulder. 3 days after he received the treatment he noticed improvement in his situation. His left shoulder was not bothering him at all, when it typically bothers him 24-hours-a-day.
It was not all amazing news for Jason though. In Jason’s left knee the posterior cruciate ligament (PCL) was completely gone. The medical staff was completely honest with Jason. There was no way that stem cells could make his PCL reappear. Jason would have to receive surgery to fix his left knee and replace his PCL.
Our medical staff is focused on giving patients the best possible care and not on extracting the most money from each patient. That is not the case for all stem cell clinics in the United States. One part of giving patients world class care is the attending medical professionals.
Real Medical Professionals
Many stem cell therapies are administered by untrained professionals. They have taken a crash course in stem cell treatments and do not understand all of the intricacies of the procedure. They also do not understand how stem cells really work and where they should be used.
All of BioXcellerator’s medical professionals are highly skilled and highly trained with years of experience. We have a wide variety of specialists in order to completely evaluate all of the patients that we see. Our entire medical team is well versed in stem cells and will guide every patient through the correct treatment plan. Not only does BioXcellerator have the best medical team, but we have all of the right certifications as well.
BioXcellerator is incredibly proud to have the proper necessary certifications for all of their stem cell therapies. Many stem cell clinics do not have any proper certifications to even handle stem cells in their laboratories, let alone inject them into patients.
Here are all of regulations and certifications that BioXcellerator follows:
- CAT Standards for the Obtention, Processing, Storage and Distribution of Blood Umbilical cord.
- INVIMA (the institution that fulfills the role of the FDA in Colombia) Standards: Good Practices for Tissue Banks and Bone Marrow.
- FACT-JACIE International standards for the collection, processing and administration of hematopoietic cell therapy products.
- ISO 14644: 2016 Standard Air quality in controlled environments.
- ISO 9001: 2015 Standard Quality Management Systems
- Colombian Resolution 2378 of 2008 Adoption of Good Clinical Practices for Research with Medicines in Humans (specifically for clinical research projects)
- ASS-RSA-GU045 Clinical Investigation Medicine and Supplies Guide INVIMA.
- ISSCR International Society for Stem Cell Research.
- GMP Spanish Agency of Medicines and Health Products.
- Enabling Standards under colombian Resolution 2003 of 2014
We take stem cell research more seriously than some of the leading universities in the entire world. We are dedicated to advancing the cause of stem cells in order to help patients with diseases that conventional medicine cannot cure.
The stem cell industry is still going through a growth period. There will be a lot of shady companies that will continue to pop up, but the market will show that these companies will falter. BioXcellerator will be the leader of the stem cell industry and advance patient therapies as quickly as possible.