First FDA-Approved Study of Stem Cells to Treat Hearing Loss Begins at
Children’s Memorial Hermann Hospital
HOUSTON, Jan. 12, 2012 /PRNewswire/ — Children’s Memorial Hermann
Hospital and Cord Blood Registry® (CBR) are launching the first
FDA-approved, Phase I safety study on the use of cord blood stem cells
to treat children with sensorineural hearing loss.
The study, which will use patients’ stem cells from their own stored
umbilical cord blood, is the first of its kind, and has the potential
to restore hearing. This follows evidence from published laboratory
studies that cord blood helps repair damaged organs in the inner ear.
The year-long study will follow 10 children, ages 6 weeks to 18 months,
who have sustained post-birth hearing loss. Children who are deaf as a
result of a genetic anomaly or syndrome are not eligible. To ensure
consistency in cord blood stem cell processing, storage, and release
for infusion, CBR is the only stem cell bank providing clients for the
“Children only have 18 months to acquire language skills and, if a
child does not hear well, they will not acquire the language skills to
speak normally,” said James Baumgartner, M.D., sponsor of the study and
guest research collaborator at The University of Texas Health Science
Center at Houston (UTHealth) Medical School.
Parents will be interviewed by phone to determine eligibility of their
children for the study. Those who meet the criteria will be admitted to
Children’s Memorial Hermann Hospital to undergo a series of blood
tests, hearing and speech tests, and an MRI that will view the tracts
that send signals from the inner ear to the brain.
The Principal Investigator is Samer Fakhri, M.D., surgeon at Memorial
Hermann-Texas Medical Center and associate professor and program
director in the Department of Otorhinolaryngology – Head & Neck Surgery
at UTHealth. Linda Baumgartner, MS, CCC-SLP, Auditory-Verbal Therapist,
is a co-investigator.
“Currently, the only treatment options for sensorineural hearing loss
are hearing aids or cochlear implants,” Dr. Fakhri said. “We hope that
this study will open avenues to additional treatment options for
hearing loss in children.”
Researchers will obtain and process the patients’ stored cord blood for
treatment. The cells then will be given to the patients via IV
infusion, and patients will be observed for several hours in the
Patients will return to the hospital to repeat all tests except the MRI
at one month and one year, and all tests with an MRI at six months.
“This study is exciting because it might offer a non-surgical option
for some children with profound loss,” Linda Baumgartner said. “More
importantly, this is the first treatment with the potential to restore
Since more infants are surviving premature birth, physicians and
researchers are seeing a rising number of very young children with
significant hearing loss. About 15 percent of children in the U.S. also
suffer from low-frequency or high-frequency hearing loss that can
impact the child’s speech, language, and social development and can
increase their risk of developing learning disabilities, according to
“We share Dr. Fakhri’s and Dr. Baumgartner’s passion and commitment to
understanding more about the potential applications of cord blood to
help repair nerve tissue,” said Heather Brown, vice president of
scientific and medical affairs at CBR. “It is exciting to be at the
forefront of research to match children who have cord blood stored with
this team of groundbreaking doctors studying autologous stem cell
therapies for hearing loss.”
The study is supported by CBR and TIRR Foundation.
For information on participation in the study, visit
About Children’s Memorial Hermann Hospital
With 11 hospitals located in the Texas Medical Center and throughout
greater Houston, Memorial Hermann is a vital healthcare resource known
for world-class clinical expertise, quality patient care, and
leading-edge technology and innovation. Children’s Memorial Hermann is
a 240-bed hospital dedicated to pediatric and neonatal care with an
additional 68 beds dedicated to women’s services. The hospital’s
compassion and healing expertise has distinguished it as one of the
finest children’s hospitals in the nation. In partnership with the
University of Texas Medical School, Children’s Memorial Hermann
specialists provide care for more than 120,000 patient visits annually,
including the tiniest premature infants, children, and adolescents.
Memorial Hermann takes a holistic approach to healthcare, offering
programs and services that address the physical, social, psychological
and spiritual aspects of well-being.
About Cord Blood Registry Center for Regenerative Medicine
Cord Blood Registry® (CBR®) is the world’s largest and most experienced
stem cell bank. The company founded the CBR Center for Regenerative
MedicineSM to support and advance medical research in regenerative
treatments and help to link client families with clinical researchers
with trials currently in place or on the horizon. CBR has consistently
led the industry in technical innovations and safeguards more than
400,000 cord blood and cord tissue collections for individuals and
their families. The company was the first family bank accredited by
AABB and the company’s quality standards have been recognized through
ISO 9001:2008 certification—the global business standard for quality.
CBR also has released more client cord blood units for specific
therapeutic use than any other family cord blood bank. For more
information, visit http://www.cordblood.com.
SOURCE Children’s Memorial Hermann Hospital
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