A blind Colorado girl with family ties to Wisconsin Dells is scheduled to undergo a controversial stem cell treatment to partially restore her vision in Thailand.

The treatment has not been approved by the Food and Drug Administration and is not offered in the United States. The girl’s mother says the family is on the “pioneer front of what medicine will be” while a Madison pediatric opthamologist and stem cell researcher called such a procedure a “back alley fraud.”

Hallie Kemp is 2 years old. She lives in Denver, Colo. with her parents, Katie and Adam Kemp. Hallie is the granddaughter of Wisconsin Dells dentist, Dr. Pat Sweeney and his wife, Mary.

Hallie was born with a condition called septo-optic dysplasia. It is an uncommon disorder marked be abnormal brain development that can leave those affected by it with blindness and pituitary gland hormone deficiencies, according to the National Institute of Neurological Disorders and Stroke Web site.

Hallie is on hormone replacement therapy to remedy the problem with her pituitary gland, but her vision has been severely impacted by the disorder. Katie says her daughter’s optic nerves are functioning at only 20 percent of what they should be and that her daughter has some light perception but can’t see objects. A component of SOD is optic nerve hypoplasia which is the name of the condition given to patients whose optic nerves are underdeveloped. The optic nerve allows a person’s brain to process what he or she sees.

In attempts to restore part of Hallie’s vision, the Kemp family is paying $35,000 for the procedure of injecting stem cells from human umbilical cord blood into the patient. Treatments are to be administered over the course of a month, according to Katie. The family is scheduled to receive the treatment in October. A company called Beike Biotech gives the treatments in China and Thailand.

According to the company’s Web site, it has treated more than 2,000 people with stem cell injections for ailments like ataxia, autism, ALS, brain trauma, cerebral infarction, cerebral hemorrhage, cerebral palsy, Guillain-Barre Syndrome, encephalopathy and spinal cord injury.

Katie said she has heard no stories of harmful side effects. She knows of people who have claimed successful outcomes and said cases have been documented by U.S. doctors with tests on patients before and after the procedure.

Katie gave the example of a 15-year-old girl from Ft. Collins, Colo. who was blind, underwent the procedure in China and can now see well enough to drive. Her story has been covered by the Denver NBC News affiliate.

Examples like that are hard to overlook, but Dr. David Gamm, a pediatric opthamologist and UW-Madison assistant professor and stem cell researcher, raises serious questions about the procedures he hears about taking place in China.

He has questions about whether the stem cells will be able to affect the optic nerve because he said there is a blood brain barrier that would block the stem cells from reaching the location where they are to do their work. Stem cells are being studied for their ability to regrow damaged tissue and save dying cells.

He also said it’s hard to know whether the success stories are from the treatment or a consequence of the nature of septo-optic dysplasia. He said some patients with the disorder have been known to regain some degree of vision over time without intervention.

Gamm also criticizes the study for charging its patients. In legitimate trials patients don’t pay money to participate, he said. He said the organizers of the experiments have a conflict of interest because they stand to benefit from positive results when the patients are paying to participate.

And he said the patients giving positive testimonials from the treatment could have been paid to do so, and the local governments could be receiving a portion of the profits.

“It’s criminal to claim false results in the hope of making a buck,” Gamm said.

Katie said there just seems to be too many accounts of success from the procedure to make that scenario plausible, and she said she’s met patients who have had the procedure in person.

Gamm said before he would undergo participating in an experimental treatment he would ask to see results of a study that was conducted independently of the local government or the hospital performing the procedure. He said such a study should explain theoretically how the treatment would work, show evidence, demonstrate that the procedure has been reviewed by experts in the field, show that it has worked on animals and show outcomes on treated and untreated patients to prove that claims of success aren’t from a “placebo effect.”

Gamm said patients are protected from fraudulent experiments in the United States and western countries by the regulations.

But Katie challenges the wisdom of the system in the United States and commented about the cloud of suspicion that seems to plague medical procedures in some countries overseas.

In the United States pharmaceutical companies manufacture drugs that aren’t natural and they are approved by the Food and Drug Administration and accepted, she said. But when another country injects a natural human cell in a procedure that has no side effects it receives a lot of skepticism, Katie said.

She sees what the family is doing for Hallie is no more dangerous than when vaccinations were new science. She said she knows of research going on in the United States concerning stem cells and believes stem cells are the future of science.

“I just feel so confident that this is something that could help Hallie’s vision,” she said.

The Kemp family is trying to raise $50,000 to cover the cost of the procedure, travel and living expenses for the month they will be in Thailand. So far they have raised $33,000. Katie said family, friends and her husband’s employer, a natural gas and liquid company, have contributed funds already. For information about Hallie, visit the family’s Web site, www.hopeforhallie.com.