The field of regenerative medicine has stirred as much debate in the United States over the past few years as it has hope. Many have hailed stem cell therapy as the future of medicine while others have questioned its efficacy and safety, discrediting the very people that are trying to make this future a reality.
As a biotechnology company specializing in regenerative medicine using adult mesenchymal stem cells (MSCs), Celltex works every day to improve the quality of life for hundreds of individuals with autoimmune, degenerative and vascular conditions. From its inception, Celltex has faced and overcome a number of unique challenges that come with navigating unchartered territory, challenges that we have overcome with transparency and remarkable results.
Today, we are at a pivotal time in our company’s history, and we feel the time is right to address questions and provide facts about our company and its technology, where we have been and where we are going.
Compliance with the U.S. Food and Drug Administration (FDA)
Celltex began operations in 2011 and overcame obstacles that might have halted operations altogether for other companies. Some have claimed that Celltex was shut down by the FDA – that is false.
Since there was no prior precedent established for Celltex’s type of operations in the United States, Celltex registered its operations with the FDA as a “cell lab” under the FDA registration of Human Cells, Tissues, and Cellular and Tissue-Based Products (“HCT/Ps”). Celltex engaged a contract manufacturer to perform laboratory services for its clients while a permanent Celltex laboratory was under construction. In June of that year, the State of Texas passed a law making it legal for Texas physicians to practice stem cell therapy within the state, and by October of 2012, over 230 individuals had banked and received their adult stem cells from Celltex in Texas.
During a routine inspection in 2012, the FDA found that the contract manufacturer’s lab operations did not comply with their standards and procedures and cited the lab for various observations. While the FDA’s list of items was not dangerous to the quality of the cells produced, the Celltex name was, nonetheless, associated with the contract manufacturer’s operations. Finding this to be unacceptable, Celltex terminated its contractual relationship with the manufacturer and proceeded to complete its own FDA-compliant laboratory, which began operations in 2013.
Shortly after the visit, the FDA informed Celltex that while the company considered itself a cell lab, the FDA considered it a drug lab. Accordingly, as stated by the FDA, all future Celltex operations would have to be performed under the FDA regulations and guidelines for the manufacture of pharmaceuticals as an “Investigative New Drug,” and that pharmaceuticals (one’s own cells, in this case) could be sold commercially (or, released/delivered to the owner) only after the company had undertaken five to seven years of clinical trials.
In 2013, Celltex’s new laboratory was completed and registered with the FDA. Today, Celltex operates its own FDA-compliant laboratory, which meets or exceeds cGMP/FDA standards and is registered with the FDA as a facility that multiplies human cells and cellular products (HCT/Ps). It is also registered with the FDA as an exporter of human cells. All of Celltex’s operations are compliant with FDA guidelines and procedures, and all of our clients’ stem cells are banked (cryogenically stored) in the United States.
Due to the FDA’s position that one’s own stem cells are considered to be a drug, and the release of those stem cells to the owner “constitutes a federal offense for the distribution of an unlicensed, unapproved drug, subject to federal fines and penalties,” Celltex cannot release one’s own stem cells to the owner in the United States.
Instead, we work closely with the closest neighboring country that has, for years, embraced stem cell therapy. Celltex also became certified and compliant with the standards and procedures of COFEPRIS (the equivalent of the FDA in Mexico), and an alliance was established with reputable certified hospitals in Mexico.
There are people in the United States who do not have the time to wait, which is the reason Celltex established alliances with reputable facilities in Cancun, where stem cell therapy is currently approved. In many other countries, including Mexico, Celltex operations fall under “cell culturing,” rather than “drug manufacturing,” making it possible for our clients to receive their own stem cells in a setting where the therapy is approved by local government, using cells that are isolated, cultured and stored in the United States in an FDA -compliant laboratory.
Once an individual’s stem cells are cultured in Celltex’s Houston-based laboratory, they are packaged in special temperature-controlled and validated containers and sent by overnight courier to Hospital Galenia in Cancun. A certified and experienced physician at Hospital Galenia then administers the cells to the owner, either through an infusion in the arm (by simple IV) or a direct injection.
At Celltex, we operate knowing that we all have a choice. We can wait another decade or more for costly clinical trials and watch as our loved ones deteriorate, or we can do something about it now. In our eyes, doing nothing is the real risk.
The beauty of our technology is that we take a person’s own adult MSCs and replicate millions of genetically identical cells to be used in regenerative therapy. The Celltex process ensures the integrity and uniformity of one’s cells in quantities never before possible and in the quantities needed for therapeutic applications (hundreds of millions). Based on clinical data we have studied from trials all over the world, there is no known risk of one’s body rejecting its own stem cells or causing harm to the individual. Efficacy has been shown in preclinical trials as well as patient testimonials and physician feedback. The extraction of the cells is a non-invasive and virtually pain-free fat extraction that takes no longer than 30 minutes, and the therapy itself is non-invasive and achieved through an IV or direct injection.
Safety in our technology
Stem cell therapy is not a new area of medicine in many parts of the world. With the controversy of embryonic stem cells inundating the public via the mainstream media, Celltex Therapeutics has made a concerted effort to educate consumers about adult stem cells, also known as autologous (meaning “coming from one’s own body”) mesenchymal stem cells (MSCs), the only kind of stem cell in which Celltex specializes.
Our proprietary technology extracts, isolates, grows and banks hundreds of millions of a client’s own MSCs for therapeutic use. This technology and the procedure have been shown to be safe in hundreds of clinical trials around the world for more than 40 years. What goes back into an individual’s body is nothing more than what came out of it – except in larger quantities.
We measure results in three ways – medical data, physician feedback and client testimonials. Each client’s medical information is collected prior to stem cell therapy and then again at multiple intervals after therapy. The post-therapy data is then compared against the previously collected data, allowing us to evaluate the results and see where there was improvement. Since we work closely with the physicians in our Physician Network and collaborate with our clients’ treating physicians, we receive feedback from them on the wellbeing of our clients both pre and post therapy. Our last form of measurement is, to us, the most valuable, and that is the feedback we get from our clients themselves. When a woman with MS who was bound to a wheelchair says she can now get around with a walker and use both of her hands again, that is how we know stem cell therapy improved her quality of life. When a six-year-old boy suffering from juvenile arthritis is now able to run and play with his brother and sister without pain and is weaned off his arthritis medications and chemo infusions because he is doing so well, it confirms what we already know – that stem cell therapy is improving his quality of life. Nevertheless, Celltex is working closely with our clients and their physicians to develop clinical case studies to follow these individuals on their journey.
All of the people featured on our website under “client testimonials” expressed great enthusiasm and interest in sharing their stories with others. These are brave individuals who have suffered chronic pain and debilitating autoimmune and degenerative diseases and who had exhausted all of the options offered by the healthcare community in the United States. Their stories are exciting, inspirational and encouraging. Celltex has never and will never share an individual’s personal health information with media or the public without full consent from the client or their guardian. Each Celltex client who has been featured in the media has volunteered to share their story because they are passionate about the potential of stem cell therapy, and they want to share their experiences with others in the same situation.
The future of Celltex
Before discovering Celltex, many of our clients had experienced years of chronic pain, Parkinson’s, MS, arthritis and many other degenerative and autoimmune conditions. Conventional treatments failed to relieve their symptoms and, in some cases, these individuals were told there was no other option. Every client who has come to Celltex was searching for one thing – a better quality of life. We are providing people with a therapy option that they have never had before. And if this technology can improve the quality of life for someone suffering from an autoimmune or degenerative disease then we are doing our part.
At Celltex, we are committed to bringing the U.S. to the forefront of regenerative medicine through our technology. We know we have a monumental task ahead of us in educating consumers, working with the medical communities through formal processes, and sharing results with government officials and agencies before the U.S. is ready to embrace this area of regenerative medicine.
We are working closely with our clients and their physicians to develop case studies on their maladies and improvements since receiving stem cell therapy. Our company is also currently involved with medical institutions to begin the process of implementing the required studies needed to meet FDA approval. Until then, our laboratory continues stem cell processing and banking in compliance with the FDA. Celltex is not a clinic, and it does not treat patients.
Our company has an interesting past, but we have an even more important future and vision. What we have learned and experienced has made this company wiser and stronger – we are proud to be here today and to see our clients doing so well.
Finally, we welcome anyone who questions the operations of Celltex to call our main number and request a tour of our laboratory. Our hope is to help those who have questions understand the possibilities that stem cells hold for improving the quality of life for everyone.
Chairman & CEO