Celltex Therapeutics is a regenerative medicine company that specializes in banking autologous mesenchymal stem cells (MSCs) for therapeutic use. In the Celltex procedure, a small fat sample is taken, from which MSCs are extracted, isolated, multiplied and stored for future use. Patients can then use these autologous (“self-derived”) stem cells for regenerative purposes through infusions or injections performed by a licensed physician.
In this article:
- Introduction to Celltex Therapeutics
- Interview with CEO David Eller
- Background of Celltex Therapeutics
- Celltex Treatment Approach
- History of Celltex Therapeutics
- Celltex and the FDA
- Celltex’s Facility in Cancun, Mexico
- Celltex Growth and Expansion
- Celltex 5-Year Goals
Introduction to Celltex Therapeutics
Since the FDA states that an individual’s stem cells are defined as a drug if they have been expanded in a laboratory (known as in vitro), Celltex began the process of undertaking clinical trials in which it will seek approval from the FDA to provide stem cells for use by physicians within the U.S. to address a range of medical conditions.
To meet the immediate needs of patients, Celltex has also taken steps to comply with the regulations established by the FDA and COFEPRIS, the Mexican equivalent of the FDA for exporting and importing MSCs.
To learn more about Celltex, enjoy this exclusive interview David Eller, President and CEO of Celltex Therapeutics.
Interview with David Eller, Celltex President and CEO
Cade Hildreth: What is your professional and scientific background?
David Eller: In the course of over three decades, I have been at the helm of both privately and publicly held companies in the areas of biotechnology, life sciences, pharmaceuticals, and bioscience research and development.
During this period, I served as President of DuPont Pharmaceuticals Company-Europe, a subsidiary of the E. I. du Pont de Nemours and Company (“the DuPont Company”); Chief Executive Officer and President of Virbac Corporation; and Founder, Chairman, and Chief Executive Officer of Granada Biosciences, Inc.
I served two terms as a member of Board of Regents of the Texas A&M University System, for a total of four years. During that time, I served as Chairman of the Board of Regents for one term, while simultaneously holding the position of Chancellor of The Texas A&M University System for a period. During this tenure, I established the Institute of Biosciences and Technology, located in the Texas Medical Center, and a number of additional bioscience programs, including establishing procedures for intellectual property commercialization.
My current and previous board leadership with medical, science and financial entities is widespread, including the Boards of Celltex Therapeutics Corporation, Baylor College of Medicine, DuPont Pharmaceuticals Company – Europe, the Foundation for Biomedical Research, Rice University Energy & Environmental Systems Institute, Memorial Hermann Hospital, Texas Chamber of Commerce, Allied Bancshares and First Interstate Bank, among others.
Background of Celltex Therapeutics
Cade Hildreth: What inspired you to found Celltex?
David Eller: Former Texas Governor Rick Perry, a longtime friend, approached me in 2011 to start Celltex Therapeutics Corporation. During his time as governor of Texas, Perry had an outstanding record as an advocate for regenerative medicine – resulting in Texas becoming a leader in regenerative medicine and the use of stem cells. His vision was for Texas to become the center of adult stem cell therapy, because he understood that Texas’ spirit and conducive climate could make it happen. He knew my background in biotechnology and life sciences, and asked me to be a part of his vision to make Texas the “stem cell capital of the United States.”
Since opening our doors in 2011, we have seen hundreds of individuals suffering from Multiple Sclerosis, Parkinson’s, debilitating systemic arthritis and various other conditions and injuries regain their quality of life. Every person has their own incredible story to tell after therapy, and with the support of our staff and our partners, we will continue to work diligently until everyone has access to the incredible promise of stem cell therapy.
Celltex Treatment Approach
Cade Hildreth: To what types of clients do you provide adult stem cells?
David Eller: Celltex uses proprietary technology in our laboratory to isolate, grow and cryopreserve (bank) hundreds of millions of an individual’s own Mesenchymal Stem Cells (MSCs) for therapeutic use to improve quality of life for those suffering from injuries, as well as autoimmune, vascular and degenerative diseases.
Cade Hildreth: What are the therapeutic advantages of working with mesenchymal stem cells (MSCs)?
David Eller: MSCs represent a mature field both academically and clinically. Based on clinical data we have studied from trials all over the world, there is no known risk of a person’s body rejecting its own stem cells or causing harm to the individual.
Celltex is focused on mesenchymal stem cells, or MSCs, because they can hone to the injured areas and secrete numerous growth factors and cytokines to trigger the body’s own remaining stem cells to differentiate into the desired injured cells (such as bone, cartilage, muscle, neuron, fat and pancreatic beta cells, along with other types of cells). MSCs can also form new blood vessels, and self-regenerate.
Other than the MSCs ability to provide optimal biological micro-environment for promoting cell/ tissue regeneration, they also have the ability to fight inflammation, prevent cell death, and direct the immune system, using other repair cell types to aid in healing. Currently over 28,000 research papers mention mesenchymal stem cells (and over 2,100 were published this year already).
In addition, dozens of other clinical trials conducted by researchers in more than 12 countries have demonstrated the safety of using MSCs, and in particular those obtained from fat. Hundreds of pre-clinical animal studies have confirmed the same findings.
History of Celltex Therapeutics
Cade Hildreth: What did the early days at Celltex look like? What were your opportunities and your challenges?
David Eller: Texas Governor Rick Perry has a dream to see Texas become the “Stem Cell Capital of the United States.” Celltex started working with Governor Perry, the Texas Medical Board and the Department of Health to create a pathway for this therapy so we could improve the quality of life of people who needed help. And so, with the support of Texas legislators, and our Governor, Celltex began providing stem cell therapy in Texas.
To the best of our knowledge, this was the first time that commercial, expanded stem cell therapy had taken place on U.S. soil. We provided stem cells for therapy to help about 230 individuals.
Then, in 2012, during a routine inspection of the lab, 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 did not concern 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 as an HCT/P (Human Cells, Tissues and Cellular and Tissue- Based Products) establishment. Today, Celltex operates its own FDA-compliant laboratory, which meets or exceeds cGMP/FDA standards. 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. Through its established alliance with a reputable and private hospital in Mexico, Celltex is certified and compliant with the standards and procedures of the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), the regulatory equivalent of the FDA in Mexico.
Celltex and the FDA
Cade Hildreth: How has FDA regulation of stem cell therapies impacted your business decisions?
David Eller: We faced enormous pressure in the wake of extensive media coverage that proclaimed that Celltex had been “shut down” by the FDA. In the face of so much controversy, we had two choices: We could fold and forget all that we accomplished, or we could find another way forward. We elected to keep fighting so that we could help many people in the years to come.
In the aftermath of that difficult time, we emerged a better and stronger company than ever before.
Today, Celltex has an incredible team of scientists and researchers led by our Chief Scientific Officer, Dr. Jane Young, who operate the laboratory 24/7, 365 days a year as they work to nurture hundreds of millions of our clients’ MSCs.
Celltex’s Facility in Cancun, Mexico
Cade Hildreth: Why did you choose Cancun, Mexico for your offshore facility?
David Eller: As mentioned, Mexico is the closest neighboring country to the United States that has, for years, embraced stem cell therapy, which is approved by the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), the regulatory equivalent of the FDA in Mexico.
Celltex follows FDA regulations concerning the export of cells to Mexico and is compliant with the standards and procedures of COFEPRIS. An alliance was established with a reputable, certified hospital in Mexico, which is approved to receive cells and administer them to patients by a licensed physician.
Cade Hildreth: How would you recommend that the FDA regulate stem cell therapy moving forward? What is the FDA doing well and where does it need to rethink its existing policies?
David Eller: Currently, the FDA classifies Celltex’s product under section 351 of the Public Health Service Act, which is what they consider “higher risk” if the cells are “more than minimally manipulated.” This makes expanded MSCs subject to the same rules as drugs.
We believe our technology using expanded MSCs should be classified under section 361 of the Public Health Service Act, which pertains to autologous cells and tissues that are only minimally manipulated.
What would this mean for us? For one thing, this means that the Celltex laboratory and process would continue to be regulated by the FDA to ensure quality, safety and sterility. This is something we are already doing at Celltex, and we believe we have established best practices in this area.
It would also allow clients to receive therapy in the United States, just as they would receive a life-saving blood transfusion, only the infusion would consist of their own adult stem cells and nothing more.
With tens of thousands, maybe even hundreds of thousands of people having received therapy using their own stem cells, the safety profile of MSCs has been established. Given their incredible safety record, we believe that MSC therapy is one of the most promising answers available to us as we seek 21st century innovations in modern medicine.
Celltex Growth and Expansion
Cade Hildreth: How would you describe Celltex’s growth and expansion?
David Eller: Though we faced challenges in the beginning, we continue to grow as a company. We still have a monumental task ahead in terms of the approval of this therapy in the United States and educating the general public about stem cell therapy.
Our company growth and the success of our technology go hand-in-hand. Our laboratory R&D team has been successful, and continues to perfect and advance our process, giving us a stronger and better lab that can keep up with growing technologies.
The biggest contributor to our growth has been our clients, who have experienced first-hand the benefits of our technology. The more people we help, the more they share their stories, which creates a stream of referrals, which is the best kind of support.
Celltex Five-Year Goals
Cade Hildreth: What are your 5-year goals for Celltex?
David Eller: We are focused on increasing technologies and expanding internationally, which we have already begun in Mexico. We are also considering expanding to Central and South America, and even India.
There is a massive effort taking place around the country to make stem cell therapy accessible to the general public, which would allow us to maintain the quality of our product at a lower cost. Celltex is at the forefront of that effort.
Our long term goal is to demonstrate to the FDA that what we are doing is safe and efficacious through clinical data, with hopes that the FDA will approve its use in the United States to the general public and, short term, for compassionate use as well.
Cade Hildreth: How can people get in touch with you or learn more about Celltex?
David Eller: Our website www.celltexbank.com is a wealth of information about the company and our process, and offers various client testimonials and videos.
We are also accessible through our Facebook page, where we post the most recent news and information about our company.
We are always open to questions. The phone number for client services is (713) 590-1000.