February 26, 2010

Stem cell therapy used for urinary incontinence

Stem cell therapy used for urinary incontinence

Researchers at Vanderbilt University Medical Center are among three North American study sites to participate in a clinical trial using autologus adult stem cell transplantation to treat an exceedingly common problem in women — stress-related urinary incontinence.

The study involves harvesting starter cells, called progenitor cells, from the participant's own thigh muscle, then sending these cells to an out-of-state lab to be refined and grown into stem cells.

After they are returned for implantation, the stem cells are injected into the bladder's sphincter in a specific area called the rhabdosphincter to reconstitute its mechanism. Two participants have been enrolled into the trial at VUMC thus far.

“In urology, this is the first substantive work being done as far as the actual clinical use of stem cells. It's very exciting from this standpoint,” said Roger Dmochowski, M.D., professor of Urologic Surgery and the

Roger Dmochowski, M.D.

Roger Dmochowski, M.D.

“This is the first efficacy study done in the United States using self-adult stem cells for purposes of treatment for urinary incontinence.”

Urinary incontinence (UI) is estimated to affect more than 200 million people worldwide and is a condition associated with social impact and reduced quality of life. Stress urinary incontinence has been reported as the most common type of UI.

“It is caused primarily by a defect in the musculature of the pelvic floor occurring during childbirth, by age or by a number of other factors,” said Melissa Kaufman, M.D., Ph.D., assistant professor of Urologic Surgery and co-investigator on this study.

Most current therapies directed at stress-related UI today do not address

Melissa Kaufman, M.D., Ph.D.

Melissa Kaufman, M.D., Ph.D.

Basic biologic functions as simple as coughing or sneezing can compromise the effectiveness of the rhabdosphincter, resulting in bladder leakage.

Currently, one of the most common minimally-invasive treatments for stress-related UI involves the use of a bulking agent such as bovine collagen, a protein made from cows, injected around the urethra.

However, there are several disadvantages to this therapy, including loss of effectiveness due to absorption, migration, the need for repeated injections and potential allergic responses to the bovine source for collagen.

“We are using these stem cells created from the patient's own body to reconstitute the rahbdosphincter mechanism,” Kaufman said. “Currently, we don't know the exact length of time this form of therapy will last in comparison to the bulking agents because these studies are new, but we certainly anticipate that if the therapy is regenerative, that if we have reconstituted the muscle, it will be much longer lasting.”

Julia Chapman, R.N., a circulating nurse in Perioperative Services at VUMC, knows all too well the challenges to quality of life brought about by stress-related UI.

When she heard about the study she was immediately interested.

“My condition was altering my quality of life. However, because I also work in urologic surgery I know there are a lot of people out there who have urinary incontinence much worse,” Chapman said.

Prior to participating in the study, Chapman had tried other interventions such as internal (Kegel) exercises and medication to treat irritable bladder, but was unable to achieve satisfactory results.

After undergoing stem cell transplantation about six months ago, Chapman is pleased with the outcome. “My results were apparent well before the period where benefits were anticipated,” she said.

“It's obviously very early, but from an efficacy standpoint, that's what we're looking for in terms of longer-term results,” Dmochowski said.

The two other sites participating in this trial are the University of Toronto and the University of Pittsburgh.

For more information about this study please call 343-2120, or visit the Vanderbilt Clinical Trials Web site at https://www.vanderbilthealth.com/clinicaltrials/.