Cord Blood Registry (CBR) is the exclusive partner for a growing number of clinical researchers focusing on the use of a child’s own cord blood stem cells to help treat pediatric brain injury and acquired hearing loss.

To ensure consistency in cord blood stem cell processing, storage and release for infusion, three separate trials have included CBR in their FDA-authorized protocol—including two at the University of Texas Health Science Center at Houston (UTHealth) working in partnership with Children’s Memorial Hermann Hospital, and a third at Georgia Health Sciences University, home of the Medical College of Georgia (MCG). This makes CBR the only family stem cell bank pairing researchers with prospective patients for these studies.

“Partnering with a series of specialists who want to research the use of a child’s own newborn blood stem cells on a variety of disease states allows CBR to help advance medical research for regenerative therapies by connecting the child whose family banked with CBR to appropriate researchers,” said Heather Brown, MS, CGC, Vice President of Scientific & Medical Affairs at Cord Blood Registry.

“The pediatric specialists from UTHealth, Children’s Memorial Hermann Hospital, and Georgia Health Sciences University are at the forefront of stem cell research as they evaluate cord blood stem cells’ ability to help facilitate the healing process after damage to nerves and tissue.”

Hearing Loss and Traumatic Brain Injury Clinical Trials Break New Ground Sensorineural hearing loss affects approximately 6 per 1,000 children by 18 years of age, with 9 percent resulting from acquired causes such as viral infection and head injury. The Principal Investigator of the hearing loss study 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.

He is joined by James Baumgartner, M.D., sponsor of the study and guest research collaborator for this first-of-its-kind FDA-regulated, Phase 1 safety study of the use of cord blood stem cells to treat children with acquired hearing loss. The trial follows evidence from published studies in animals that cord blood treatment can repair damaged organs in the inner ear. Clients of CBR who have sustained a post-birth hearing loss and are 6 weeks to 2 years old may be eligible for the year-long study.

“The window of opportunity to foster normal language development is limited,” said James Baumgartner, M.D.  ”This is the first study of its kind with the potential to actually restore hearing in children and allow for more normal speech and language development.”

Although the neurologic outcome for nearly all types of brain injury (with the exception of abuse) is better for children than adults, trauma is the leading cause of death in children, and the majority of the deaths are attributed to head injury.Distinguished professor of pediatric surgery and pediatrics at UTHealth, Charles S. Cox, M.D. launched an innovative study building on a growing portfolio of research using stem cell-based therapies for neurological damage.

The study will enroll 10 children ages 18 months to 17 years who have umbilical cord blood banked with CBR and have suffered a traumatic brain injury (TBI) and are enrolled in the study within 6-18 months of sustaining the injury. Read more about the trial here.

“The reason we have become interested in cord blood cells is because of the possibility of autologous therapy, meaning using your own cells. And the preclinical models have demonstrated some really fascinating neurological preservation effects to really support these Phase 1 trials,” says Charles S. Cox, M.D., principle investigator of the trial.

“There’s anecdotal experience in other types of neurological injuries that reassures us in terms of the safety of the approach and there are some anecdotal hints at it being beneficial in certain types of brain injury.”

Georgia Health Sciences University (GHSU) Focuses on Cerebral Palsy

At the GHSU in Augusta, Dr. James Carroll, professor and chief of pediatric neurology, embarked on the first FDA-regulated clinical trial to determine whether an infusion of stem cells from a child’s own umbilical cord blood can improve the quality of life for children with cerebral palsy. The study will include 40 children whose parents have stored their cord blood at CBR and meet inclusion criteria.

“Using a child’s own stem cells as a possible treatment is the safest form of stem cell transplantation because it carries virtually no threat of immune system rejection,” said Dr. Carroll. “Our focus on cerebral palsy breaks new ground in advancing therapies to change the course of these kinds of brain injury—a condition for which there is currently no cure.”

Cerebral palsy, caused by a brain injury or lack of oxygen in the brain before birth or during the first few years of life, can impair movement, learning, hearing, vision and cognitive skills. Two to three children in 1,000 are affected by it, according to the Centers for Disease Control.

Cord Blood Stem Cell Infusions Move From the Lab to the Clinic

These multi-year studies are a first step to move promising pre-clinical or animal research of cord blood stem cells into clinical trials in patients. Through the CBR Center for Regenerative Medicine, CBR will continue to partner with physicians who are interested in advancing cellular therapies in regenerative applications.

“The benefits of cord blood stem cells being very young, easy to obtain, unspecialized cells which have had limited exposure to environmental toxins or infectious diseases and easy to store for long terms without any loss of function, make them an attractive source for cellular therapy researchers today,” adds Brown.

“We are encouraged to see interest from such diverse researchers from neurosurgeons to endocrinologists and cardiac specialists.”

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Because of care advances, more infants and children with previously lethal health problems are surviving. Many, however, are left with lifelong neurologic impairment.

A Children’s Hospital Boston study of more than 25 million pediatric hospitalizations in the U.S. now shows that neurologically impaired children, though still a relatively small part of the overall population, account for increasing hospital resources, particularly within children’s hospitals.

Their analysis, based on data from the Agency for Healthcare Research and Quality Kids’ Inpatient Database, was published online January 17 in PLoS Medicine. The researchers analyzed KID data from 1997, 2000, 2003, and 2006, encompassing 25.7 million hospitalizations of children age 0 to 18. Of these, 1.3 million hospitalizations were for children with neurologic conditions, primarily cerebral palsy and epilepsy.

During the 10-year period, children with neurologic diagnoses were admitted more to children’s hospitals and less to community hospitals. At non-children’s hospitals, they made up a falling share of admissions (from 3 percent in 1997 to 2.5 percent in 2006); at children’s hospitals, they made up a rising share (from 11.7 percent of admissions in 1997 to 13.5 percent in 2006).

Within children’s hospitals, neurologically impaired children accounted for an increasing proportion of resources: In 2006, they accounted for 25 percent of all bed days (up from 21.8 percent in 1997) and 29 percent of hospital charges ($12 billion, up from 27 percent in 1997).

“Our findings suggest that children’s and non-children’s hospitals are caring for increasingly different populations of children,” says first author, Jay Berry, MD, MPH, an attending physician in the Complex Care Service at Children’s Hospital Boston.  “Children with neurologic impairment tend to require expensive, lengthy hospitalizations. As policymakers increasingly focus on healthcare costs, we must be careful to not jeopardize the care these children receive as health reforms are considered.”

The researchers note that improved care delivery and coordination could lead to reduced hospital utilization and better patient outcomes. Children with severe neurologic conditions commonly have additional health problems, such as respiratory and feeding problems, that make their care needs more complex. Yet studies indicate that pediatric providers often feel unprepared to assess and treat them.

The result, the researchers write, is uncoordinated, crisis-driven care that can lead to a disproportionate share of emergency care and frequent re-hospitalizations that drive up costs. “We’re nervous that many children with neurologic impairment are without a healthcare provider who is taking charge of their care and making sure that all of their healthcare needs are adequately addressed,” says Berry.

In the study, inpatient utilization increased most markedly among neurologically impaired adolescents. Across all hospitals, this group of children had a 28 percent increase in hospitalizations from 1997 to 2006, while children of the same age without neurologic diagnoses had an 8.4 percent decrease in hospitalizations.

“Children with severe neurologic impairment tend to have more health problems as they reach adolescence and young adulthood,” says Berry. “This coincides with a difficult period where they begin to outgrow their pediatric providers, but have trouble transferring their care to adult providers.”

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