olivia torani
A research team at VCU Health is leading a clinical trial evaluating new treatments for fecal incontinence and sudden loss of bowel control. The treatment involves implanting a bioengineered sphincter muscle derived from the patient’s natural cells to help the patient regain control of his or her bowels.
The transplant surgery for the clinical trial is being led by University Associate Professor Jaime Ball, MD. surgery and the chief Colon/rectal surgery in Virginia Commonwealth University School of Medicine.
“Although there have been no new treatments for this disease for more than a decade, we have seen great excitement among patients about the possibility of new treatments,” she said. “We are receiving calls from patients across the country asking about their eligibility for clinical trials.”
Ball and her team successfully completed the first transplant last summer and plan to enroll eligible patients over the next three years.
“We are very pleased with the progress of our clinical trials to date,” said Dr. Khalil N. Bitar, Founder and CEO. self bio, a Richmond-based biotechnology company that designed a bioengineered sphincter. “This is a major step forward in the development of BioSphincter as a potential treatment for fecal incontinence.”
Fecal incontinence: a common but hidden health problem
Fecal incontinence is the involuntary loss of stool or fecal material. According to estimates from the National Institutes of Health, 1 in 3 adults People experience fecal incontinence throughout their lives and are more likely to develop this condition as they age.
“Many patients are embarrassed by the condition and stop going out socially for fear of not being able to find a bathroom or having an accident,” Dr. Ball says. “Many of them don’t even talk to their doctors or family members about this condition. They start to narrow down the structure of their day, their social structure, their friendships. It can really isolate people. ”
There are many causes of fecal incontinence, one of which is internal anal sphincter dysfunction. The internal anal sphincter is a ring of smooth muscle inside the rectum. When these muscles become weak or damaged, such as due to chronic illness or injury, you may lose control of your bowel movements.
There hasn’t been a new treatment for this condition in over a decade, and we’ve seen a lot of excitement from patients about the possibility of new treatments.
Jaime Ball, MD, Chief of Colon and Rectal Surgery, VCU School of Medicine
A variety of treatments and procedures can help you maintain better control of your bowel movements, including medications, physical therapy, surgery, and nerve stimulation. However, some people may still have symptoms even after treatment.
“We see patients who have tried all available treatments and still have bowel control problems, and this is very frustrating for them,” Ball says.
From bench to bedside
BioSphincter is made from stem cell tissue that Ball and her surgical team collect from patients’ sphincters and small intestines via biopsies. Her biomedical team at CellfBio, led by Bitar, will grow the implant over her six to eight weeks using tissue samples. The patient then undergoes surgery to implant the bioengineered implant.
“Many treatments are designed to manage the symptoms of fecal incontinence rather than restore function. That’s where our technology comes in,” Vitale said. “The bioengineered tissue is intended to improve or replace the internal anal sphincter, which helps control the bowels. The BioSphincter is also the first implant of its kind made from the patient’s native tissue. .”
Mr. Bitar began researching this technology as a research professor and director of pediatric gastrointestinal research at the University of Michigan, then moved to Wake Forest University where he served as a professor and director of the gastrointestinal program. There he connected with Ball, who at the time was working as an assistant professor and colorectal surgeon. Since they met, they have worked together with him for over 12 years to further develop his BioSphincter implant.
Through this collaboration, researchers have worked together to take this innovation from bench to bedside. Mr. Ball, an expert surgeon and clinical researcher, has led preclinical research on this therapy and helped navigate the clinical trial approval process.
“Partnerships in science and medicine are so important because it’s incredibly difficult for one person to do everything,” Ball said.
Treating patients with bowel control problems in Richmond and other areas
The clinical trial will enroll patients whose symptoms persist after all available treatments for fecal incontinence have been tried.
Although the primary goal of the clinical trial is to evaluate the safety of the implant, researchers also plan to measure the technology’s effectiveness as a treatment for fecal incontinence. Researchers plan to assess the physical function of the bioengineered muscle tissue, the frequency and severity of fecal incontinence patients experience, and whether patients’ quality of life changes after the implant. .
The study will enroll patients first at VCU Health and then at additional sites.
“We decided to conduct the clinical trial at multiple sites to show that this procedure can be performed anywhere in the country,” Ball said. “We wanted to show that the BioSphincter can be manufactured here in our lab and shipped anywhere the patient is, while also showing that this procedure can also be performed by other colon and rectal surgeons. .”