A stem cell therapy being administered to treat multiple sclerosis (MS) outside the United States was recently touted by an MS patient who traveled to Mexico to receive the therapy, revealing significant improvements in her quality of life. Debbie Bertrand, an MS patient who was diagnosed in 2001, is sharing her positive experiences with receiving the stem cell therapy, despite the fact that Celltex Therapeutics, the Sugar Land, Texas-based biotechnology company responsible for the therapy, was scrutinized by the U.S. Food and Drug Administration (FDA) in 2012 as part of the ongoing controversy about the treatment approach.
There is currently no cure for the chronic disease that affects over 2.3 million people worldwide, but stem cell treatment may help in the management of the disease’s progressively debilitating symptoms. MS leads to problems with vision, movement, balance, and cognition, dramatically affecting quality of life. However, the stem cell culturing and banking technology from Celltex is a novel therapeutic method that, according to the company, is helping to improve the quality of life of patients with degenerative and autoimmune conditions.
“I am very happy with the results I have seen,” said Debbie Bertrand in a Celltex press release. “Not only do I have my doctor’s blessing, I have never experienced any negative side effects. I still take one oral drug for MS, but I haven’t had daily injections for MS in four years. I hope to see this process help others in my situation, and I am thankful to Celltex for bringing this technology to the United States.”
Bertrand, who was born in Texas and diagnosed with MS 14 years ago, was recently treated with Celltex’s stem cell therapy at Hospital Galenia in Cancun, Mexico. Prior to treatment, she started experiencing numbness in the hands and feet and tried to enter four different clinical trials, but did not meet the criteria for any of them. As a result, she followed the recommendation of a fellow churchgoer and made contact with Dr. Stanley Jones, a Houston-area orthopedic surgeon who treated Texas Governor Rick Perry with stem cell therapy in the past, to understand more about the novel therapy and how to receive it abroad.
The therapy isolates, cultures and stores hundreds of millions of a patient’s own adult mesenchymal stem cells (MSCs) in order to use them as a regenerative therapy. The process involves the extraction of MSCs through a portion of abdominal fat, after which the cells are separated from the fat and stored to be used in the future.
Debbie received her first infusion in October 2011 and started feeling the improvements in her strength and energy shortly after. Nine months after beginning the treatment, she was able to leave her wheelchair and began using a walker. Bertrand plans to receive a third round of stem cell therapy next month in Cancun.
Celltex started providing the stem cell treatment in the U.S., but in 2012 a warning from the FDA prompted them to move their treatment activities and begin treating patients in Mexico. The FDA advised the company about their procedures, which included more than minimal manipulation of the stem cells and was already considered a drug.
Therefore, according to the FDA’s guidelines, Celltex would need their approval to administer the treatment in the United States, unlike other stem cell therapies that do not require FDA approval if there is no manipulation of cells. In addition, the FDA warned the company about failing to correct problems in their cell processing, which had been identified five months earlier.
In spite of the controversy, stem cell treatments for MS continue to make headlines and stoke the interest of multiple sclerosis patients desperate for a viable alternative to therapies that often have little effect on the progressive form of the disease. Last February, a phase 2 clinical study from an international group of research centers compared head-to-head autologous hematopoietic stem cell transplantation (AHSCT) and mitoxantrone in the treatment of patients with secondary progressive or relapsing-remitting multiple sclerosis. The encouraging findings showed that MRI-detected brain lesions were reduced by 79% in patients undergoing AHSCT compared to patients treated with mitoxantrone.