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For all Stephanie Conner knew, her daughter would be born deaf, blind and with organ damage — the result of an often symptomless virus Stephanie had passed to her unborn child.
So when the girl, Madeline, was finally delivered at a Miami hospital, Stephanie and her husband considered it a major blessing that the girl’s biggest problem was her inability to hear.
Now, the LaBelle family hopes medical science will deliver another round of news verging on the miraculous: a stem cell cure (or partial cure) of Madeline’s hearing loss.
Madeline, who is nearly 2 years old, is the first person in the nation to take part in a new Food and Drug Administration-approved study of stem cell treatment of sensorineural hearing loss.
Children’s Memorial Hermann Hospital in Houston and California-based Cord Blood Registry will eventually enroll another nine children in this first phase of the study.
Unlike some advertised stem cell treatments that may cost patients tens of thousands of dollars — and, according to critics, are little more than quackery — the Conners paid nothing to take part and have been promised no specific results.
The process is simple: Doctors inject the children with stem cells from their own stored umbilical cords. Because it is the patients’ own blood, there is little chance the treatment will produce side effects.
In theory, the treatment will adjust patients’ immune systems to encourage their bodies to repair themselves. In truth, researchers have no idea if it will work.
Earlier Italian studies on mice concluded that stem cells may help the body repair damaged cells in the ear and restore some hearing in these types of cases, according to a 2008 published report in the University of South Florida journal Cell Transplantation.
The only other available treatments for Madeline’s kind of deafness are hearing aids and cochlear implants.
“I’m expecting really good results,” Stephanie Conner said. “I feel like God put this here in front of us for a reason.”
Madeline’s parents have a reason to be cautiously optimistic. Two of three preliminary tests after the treatment in January showed improvement in the girl’s hearing, the family said.
The Conners will head back to Texas in July, and again in January, to get a more detailed assessment of Madeline’s improvement.
This first phase will determine if the treatment is safe. Eventually, the study could span several years and include a much broader pool of participants.
For now, researchers involved with the study won’t release any of their early data, though they are candid about their expectations about outcomes for this part of the study.
“We have no idea,” said Dr. James Baumgartner, study sponsor and a neurosurgeon at Florida Hospital for Children in Orlando. “Hopefully there will be some children who respond so we can figure out timing and dosing.”
She's learning
Prenatal testing gave the family an early indication there may be trouble.
Doctors told Stephanie Conner that she had been infected with the cytomegalovirus, known as CMV, which commonly causes no symptom.
The virus, which is spread by close contact with infected children or adults, is present in an estimated 50 percent to 80 percent of U.S. adults age 40 and younger, according to the Centers for Disease Control and Prevention.
But fetuses contracting the virus from their mothers have a one in five chance of developing serious health problems, the CDC notes. In Madeline’s case, doctors worried she would have brain damage, blindness, deafness and trouble with her heart and liver.
Stephanie and Joel braced for the worst.
Instead, Madeline’s biggest medical issue was her near total deafness. One eye showed signs of mild scarring, an indication of some potential damage. But today, the girl’s vision is expected to be normal.
She wears hearing aids in both ears. With them, and the constant instruction from her parents, she has been able to learn some speech.
“Sometimes I feel sorry for parents with ‘normal’ children because they don’t get to feel this kind of joy,” Stephanie Conner said.
No time to lose
Madeline’s involvement with the study involved a bit of little luck.
It started when Stephanie Conner randomly came across an article about parents who decided to freeze the blood contained in their children’s umbilical cords. The blood is rich in stem cells that have shown promise as a treatment tool in a wide range of medical conditions.
She opted for Cord Blood Registry, which she later discovered was involved with the hearing study with Children’s Memorial Hermann Hospital.
The study is limited to children between the ages of 6 weeks and 18 months, whose hearing loss is acquired and not related to a genetic defect. For the sake of consistency, they must also have stored umbilical cords with the Cord Blood Registry.
Sensorineural hearing loss stems from inner ear or brain damage, or a malfunction in the nerve pathways from the ear to the brain.
Children must have a certain level of hearing by the time they are almost 4 years old or they won’t be able to learn speech, said Linda Baumgartner, an auditory-verbal therapist in Orlando and study co-investigator.
“Hearing loss is a neurological emergency in an infant, if you want to develop spoken language,” said Baumgartner, who is married to Dr. James Baumgartner, the study sponsor. “Sound deprivation means that the door to that room is closing.”
Not for everyone
Despite this study, many in the medical community urge parents to take their time before opting to store umbilical cord blood for themselves.
The American Academy of Pediatrics recommends against it unless children fall into a high-risk health category. Instead, the organization believes parents should donate cord blood to storage banks and make it accessible to any family in need.
Private storage does not come cheap. Cord Blood Registry charges $2,070 for a one-time “processing/preparation fee” and $125 for the first year of storage.
For their part, the Conners are glad they did.
Madeline can now speak and is able to hear others speak, though it’s still unclear how much of this has to do with the treatment. Her parents say one of the biggest improvements is Madeline’s ability to more easily identify the source of sounds.
Delayed speech aside, she’s become quite the chatterbox and is able to speak a variety of words — Mamma, Dadda, Eli (her brother), various animals names, and so on — that her parents worried might take much longer for her to learn.
Whatever the outcome of Madeline’s treatment, it has provided hope for improvement that they did not have before.
Looking ahead, Joel Conner, Madeline’s father, said he has tried to temper his expectations.
“I’m just thankful she’s healthy,” Joel Conner said. “I think she’s going to be fine even if she doesn’t improve.”