"We believe we have developed a long-lasting and effective treatment that is especially promising because it is generated from the patient's own body," said Ferdinand Frauscher, MD, associate professor of radiology, Medical University of Innsbruck, Austria, who made his formal oral presentation on November 28^th.

In a trial involving 20 women, 90% achieved virtually complete relief of incontinence within 2 weeks of implantation. "The use of transurethral 3-dimensional ultrasound is the critical element in our success," Dr. Frauscher said in a press briefing November 29^th.

Previous attempts to use stem cells failed because the cells were not placed correctly, Dr. Frauscher said. "We need ultrasound to do this correctly," he said. "Without ultrasound we thought we were placing cells in the sphincter but we were not doing that."

"This is a most promising study," said Michael Brant-Zawadski, MD, medical director for radiology, Hoag Memorial Hospital, Newport Beach, California, United States, who moderated the press briefing on behalf of the RSNA. "If these results can be replicated, the work shown here could result in life-changing improvement for millions of people with incontinence. When we reviewed the papers for this meeting we thought that this study was one of the most exciting presentations."

Dr. Frauscher explained that skeletal stem cells are extracted from the patient and are then grown in culture for about 6 weeks until there are about 50 million cells. Then, under ultrasound guidance, the cells are injected into the sphincter. Pre-clinical studies of the procedure showed that the cells linked up with existing cells to form a tighter sphincter muscle, capable of controlling the urethra and allowing the patient to regain continence.

"These are very intelligent cells," Dr. Frauscher said. "When they connect with other cells, they stop growing." He said it takes about 2 weeks for the cells to complete their mission. However, some women in the study reported that they appeared to benefit 1 day after the cells were injected. He said that was probably due to a "bulking" effect of the cells, creating pressure on the urethra.

He said 15% of the women required a second injection, believed to be due to scar tissue that formed during previous surgical procedures to try to correct incontinence. Of the two women (10%) who did not achieve complete relief of urinary incontinence, one did report improved symptoms.

The procedure appeared to fail in the oldest recipient of the cells, an 84-year-old woman.


[Presentation title: "Ultrasound-Guided Transurethral Injection of Adult Stem Cells for Treatment of Urinary Incontinence: First Clinical Results." Abstract SSA06-01]

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