Fecal incontinence stem-cell clinical trial opens at UCI Health

Fecal incontinence stem-cell clinical trial opens at UCI Health

Therapy may restore function in patients with childbirth-related incontinence, which can affect 30% of women

Orange, Calif. - UCI Health has launched a clinical trial for a novel stem cell-derived therapy that shows promise for restoring anal sphincter function in patients with childbirth-related fecal incontinence, said colorectal surgeon Dr. Joseph C. Carmichael, principal investigator of the study.

The phase 3 trial, designed to test the effectiveness and safety of iltamiocel, a cellular treatment made from a patient's own muscle cells, is being conducted under the auspices of the UCI Alpha Clinic, the clinical trial arm of the UC Irvine Sue & Bill Gross Stem Cell Research Center.

UCI Health is one of only three locations on the West Coast to offer the potentially groundbreaking therapy developed by Cook Myosite Inc., a leader in regenerative muscle cell research.

Obstetric injury-related fecal incontinence is a distressing and seldom-discussed complication of vaginal childbirth. It can persist long after a woman has otherwise recovered from the birth and it can severely impair daily life.

"The problem is quite prevalent," said Carmichael, who also serves as chief medical officer and a senior vice president of UCI Health. "About 30% of women who deliver vaginally can incur an anal sphincter muscle injury caused by an episiotomy or perineal tear."

Potentially life-changing

The novel therapy to renew muscle function has the potential to be a life-changing - and minimally invasive - option for these patients, he said. "This new approach uses a small sample of a patient's own best muscle progenitor cells biopsied from their thigh, then amplifies and reimplants them."

After collecting and processing a patient's own muscle cells, the final product is injected into the anal sphincter muscle, where it can form new muscle and strengthen existing tissue.

Given promising results reported from an early phase study of iltamiocel involving 48 patients, Carmichael was eager to work with the UCI Alpha Clinic to bring the next phase of the clinical trial to patients of the UCI Health Chao Digestive Health Institute.

The study is open to women ages 18 and older who have experienced chronic fecal incontinence for more than 12 months.

"Typically, they would have had over four episodes within a four-week period and a history of an obstetric injury," Carmichael said of the ideal study candidates. "They would have tried and not responded to other types of management, such as modifying their diet and pelvic-floor strength training for at least six months before enrollment."

The double-blind clinical trial will enroll 200 women at 19 U.S. locations. Half will be treated with iltamiocel, the other half with a placebo, and neither patient nor doctor will know who received the iltamiocel. Patients will be monitored for two years to test the therapy's efficacy.

"One great aspect of this clinical trial is that after the first year, the study will no longer be blind and patients in the placebo group will have access to iltamiocel," said Carmichael.

Alternative therapies

Traditional treatment for damaged sphincter muscles has been surgery to tighten them, requiring a hospital stay and weeks of recovery. More recently, some patients have had success with implantable devices.

"Now we have newer treatments that are far less invasive," he said. "One involves implanting a tiny nerve stimulator that dramatically improves both urinary and fecal continence."

However, many people challenged by chronic incontinence do not seek treatment. Instead, they develop workarounds to compensate for their lack of bowel control, such as always carrying a change of clothes and mapping out accessible bathroom locations before leaving home. Some even avoid social activities altogether.

"We've gotten better with people talking about incontinence," the surgeon said. But he advises people to reach out to their healthcare providers because there is help available.

"It's extremely rewarding to me as a provider when my patients tell me that they are starting to enjoy more time with friends and family because they aren't worried about having to race to a bathroom," he says.

Carmichael encourages women interested in the iltamiocel trial to make an appointment with a UCI Health colorectal surgeon.

Learn more about the iltamiocel trial ›

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About UCI Health

UCI Health, one of California's largest academic health systems, is the clinical enterprise of the University of California, Irvine. The system comprises its main campus UCI Medical Center, a 459-bed, acute care hospital in Orange, Calif., four hospitals and affiliated physicians of the UCI Health Community Network in Orange and Los Angeles counties and ambulatory care centers across the region. Recognized as a Top Hospital by The Leapfrog Group, UCI Medical Center provides tertiary and quaternary care and is home to Orange County's only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program and American College of Surgeons-verified Level I adult and Level II pediatric trauma center, gold level 1 geriatric emergency department and regional burn center. UCI Health serves a region of nearly 4 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us on Facebook, Instagram, LinkedIn and Twitter.

About UCI Alpha Clinic

The UCI Alpha Clinic, the clinical trial arm of the UC Irvine Sue & Bill Gross Stem Cell Research Center, is part of a network of the leading medical centers funded by the California Institute for Regenerative Medicine. It specializes in delivering leading-edge stem cell clinical trials and gene therapy to patients, and it seeks to accelerate the development of new treatments through partnerships with patients, medical providers and clinical trial sponsors. Visit stemcell.uci.edu to learn more about our regenerative medicine research.