Young Woman with Juvenile Arthritis and Dysautonomia Sees Major Improvements after Receiving Her Own Adult Stem Cells

HOUSTON–(BUSINESS WIRE)–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.

“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.”

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.”

For more information about Celltex and the process of stem cell banking
or to review frequently asked questions about stem cell therapy, please
If you would like to speak to a Celltex client service representative
about banking your stem cells, please call (713) 590-1000.


For Celltex
Lisa M. Martin, (713) 552-1055