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Celltex: Sarah Hughes Testimonial

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NEWS RELEASE

Young woman with juvenile arthritis and dysautonomia sees major improvements after receiving her own adult stem cells

HOUSTON (September 22, 2015) — A 23-year-old woman with systemic juvenile idiopathic arthritis (SJIA) and another related disorder called dysautonomia is seeing major improvements in her quality of life after receiving her own adult mesenchymal stem cells (MSCs), thanks to Houston-based biotechnology company Celltex Therapeutics Corporation.

SJIA is an autoimmune disease affecting approximately 30,000 children in the United States, and there is no known cure. For Sarah Hughes, diagnosed at 11 months of age, the disease not only caused persistent joint inflammation and stiffness, it also led to the development of dysautonomia that prevented her from being able to stand for more than a few minutes at a time, digest food properly, keep blood pressure normalized and prevent constriction of blood vessels. These associated maladies were caused by dysautonomia which can be associated with other diseases like SJIA. The dysautonomia was also associated with spontaneous spinal fluid leaks, drop in blood pressure to 40/0, prevented food absorption, produced severe migraine headaches, and affected the neurotransmitters in the brain that regulate the autonomic nervous system.

Sarah could not gain weight or stand for more than five minutes at a time, and she always felt cold as a result of not being able to generate warmth in any of her extremities. There is no cure for dysautonomia, and damage to the autonomic nerves is oftentimes not reversible. In Sarah’s case, comprehensive disease management is essential in improving the quality of life.

“Before receiving my Celltex stem cells, I was on continuous tube feeds 24/7 or TPN and lipids and was literally slowly starving to death. To slow my immune system down, I received high-dose intravenous steroids and high-dose chemotherapies in addition to 23 maintenance medications. I was on limited bed rest due to leaks in my spinal cord and overall weakness caused by my immune system,” says Sarah. “I was unable to be upright or go swimming in the pool, or really do anything considered normal. My muscles had atrophied and I looked like a skeleton; my hair was thin, and I looked as sick as I felt.”

After 22 years of suffering with her disease, Sarah received her own adult stem cells with the support of her family and close friends. Her family had researched Celltex and its proprietary technology, which isolates, multiplies and stores autologous (one’s own) adult stem cells (MSCs) to be used for regenerative therapy in a number of conditions, including vascular, degenerative and autoimmune diseases.

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“Adult MSCs have the remarkable potential of migrating to different parts of the body, recognizing sites of injury and inflammation, and are then able to reduce inflammation and repair the damaged tissue,” Celltex Chairman and CEO David Eller says.

MSCs have been shown to be effective in a number of pre-clinical studies and clinical trials, as stem cells can regulate the immune system by releasing anti-inflammatory agents in response to inflammatory conditions such as those that occur in autoimmune diseases.

The regenerative and immunomodulatory abilities of MSCs make them also therapeutically beneficial in degenerative and autoimmune conditions like osteoarthritis, rheumatoid and psoriatic arthritis, multiple sclerosis and Parkinson’s disease.

Celltex obtains MSCs through a fat extraction from an individual’s abdomen in a 30-minute out-patient procedure that requires no recovery time. From a thumb-size (2-20 cc) sample of fat, the individual’s MSCs are isolated, multiplied and stored at -300 degrees Fahrenheit for future use. The fat extraction process only happens once, as Celltex will always have a master bank of an individual’s stem cells should he or she need them in three months or in 30 years.

Celltex’s stem cell processing and banking methods ensure the genetic integrity and stability of an individual’s cells, which are multiplied in quantities never before possible, and are then used for therapeutic applications. An individual can use his or her banked stem cells for regenerative and immune therapy through infusions or injections performed by a licensed physician.

After having her MSCs extracted and banked by Celltex, Sarah traveled to Cancun, Mexico and received her own stem cells through an intravenous infusion performed by a highly qualified, licensed physician at Hospital Galenia. Following therapy, Sarah’s family and her doctors have seen vast improvements in her body.

“I am doing well after my stem cell therapy,” says Sarah. “Right after the infusion I noticed increased hunger and energy. Around the second month, I was able to eat food for the most part without stomach pain and was able to properly digest and absorb the nutrients. I have not had a spinal fluid leak since December and have been able to swim in a pool and relax in a hot tub. By mid-January I was able to eat normal food during the day. Seven months after receiving my stem cells, I am walking two miles a day, riding horses, exercising, and have enrolled in more college classes. I have gained significant weight and muscle mass and my hair is growing. My treating doctors are thrilled with my response and tell me I give hope to those who have no hope.”

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Sarah is overseen by a team of physicians in the Texas Medical Center.

As it stands today, the U.S. Food and Drug Administration (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 receive his or her own MSCs in the United States until clinical trials have been conducted. These trials can take years to complete, but Celltex has begun that process in cooperation with highly qualified medical and scientific institutions.

“Following the conclusion of successful clinical trials, we will seek approval from the FDA to provide adult stem cells for use by physicians in the United States. In the interim, to meet the immediate needs of our clients, we took steps to comply with the regulations established by the FDA and the Federal Commission for the Protection against Sanitary Risk (COFEPRIS), which is the equivalent of the FDA in Mexico, for exporting and importing MSCs,” says Eller. “Celltex works with an established, certified hospital in Mexico where highly qualified, independently licensed physicians make it possible for Celltex’s clients to receive their own cells for therapeutic purposes.”

Currently, everything from the stem cell isolation process to expansion and banking is handled in Houston at Celltex’s lab. When it is time for therapy, clients work with Celltex client service coordinators to schedule their therapy and travel to Mexico. After therapy, the individual returns home to let his or her body begin the process of healing itself.

Sarah states, “I have spent most of my life in hospitals, in critical condition. Since receiving my stem cells I have not been hospitalized or immune suppressed, so it is so nice to begin to feel ‘normal.’ I still have bad days, but my bad days are becoming less and less severe and less frequent. My bad days now are better than my absolute best pre-stem cell days. I am able to do so much more than my doctors or I ever imagined possible. Before the stem cells I was so sick and fragile; now I feel like an actual person.”

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