Celltex Therapeutics Corporation, a Houston-based biotechnology company, was founded in 2011 by David Eller and internationally known spine surgeon, Dr. Stanley Jones, to spearhead breakthroughs in regenerative medicine through adult stem cells. Celltex uses exclusive technology that isolates, multiplies and stores adult, autologous, adipose (fat tissue)-derived mesenchymal stem cells (MSCs) to be used for regenerative therapy in a number of conditions including vascular, autoimmune and degenerative diseases.
The MSCs are extracted from an individual’s own fat in a quick and relatively painless procedure in a doctor’s office that extracts only a small fat sample and requires no recovery time. From this fat, the individual’s MSCs are isolated, multiplied and stored for future use (this is known as cell banking). Celltex’s proprietary stem cell processing and banking methods ensure the genetic integrity and uniformity of an individual’s cells in quantities never before possible and in the quantities necessary for therapeutic applications. An individual can then use his or her banked stem cells for regenerative therapy through infusions or injections performed by a licensed physician.
Dr. Stanley Jones was determined to bring this technology to the United States after suffering a debilitating bout of autoimmune arthritis that rendered him unable to perform surgery and threatened to end his career. He traveled to Asia in 2010 and 2011 to receive regenerative therapy using his own stem cells. Where conventional treatments failed to resolve his symptoms, stem cell therapy brought relief. Within four months of receiving his own stem cells, Jones was able to return to his surgical practice. MSCs have been, and continue to be, used in many countries, so in 2011, Eller and Jones founded Celltex to bring the potential of stem cell therapy to the United States.
But the road hasn’t been easy as Celltex has faced and overcome many challenges. In 2012, quality control and processes at the lab run by Celltex’s contract manufacturer were brought under question by both Celltex and the U.S. Food and Drug Administration (FDA). Celltex took matters into its own hands, breaking its affiliation with the contract manufacturer and opening its own controlled laboratory in Houston, which is compliant with current Good Manufacturing Practice (cGMP) and the FDA.
In another challenge, the FDA has taken the position that an individual’s own stem cells are considered a drug if they have been expanded in large quantities; therefore, an individual may not use his or her own cells in the United States until clinical trials have been conducted. These trials can take years to complete, but Celltex has already begun the process, in cooperation with highly qualified researchers, and medical and scientific institutions. Following the conclusion of successful clinical trials, Celltex will seek approval from the FDA to provide stem cells for use by physicians in the United States to treat various medical conditions. In the meantime, to meet the immediate needs of its clients, Celltex took steps to comply with the regulations established by the FDA and COFEPRIS, the Mexican equivalent of the FDA for exporting and importing MSCs, respectively. Celltex works with established, certified hospitals in Mexico where independent, highly qualified licensed physicians make it possible for Celltex’s cell-banking clients to receive their own cells for therapeutic purposes.
Today, Celltex Therapeutics Corporation remains committed to leading the United States into the future of regenerative medicine through adult stem cells. Its industry leadership and visionary approach continue to drive the company to improve the quality of life of thousands of individuals, with a concerted focus to make this therapy accessible to all in the near future.