They are combining stem cells from the lining of a woman’s own uterus with nano-biomaterials – or biodegradable materials engineered on the nanoscale – in a world-first approach to develop safer, more effective treatments for pelvic organ prolapse.
Pelvic organ prolapse (POP) is a lifelong sometimes debilitating condition, usually caused by the impact of childbirth. It affects an estimated one in four women and around one in two women aged over 50.
Up to a third of women with POP require multiple treatments in their lifetime.
Seven years in the making, the multi-disciplinary project includes collaborators from the Ritchie Centre at Hudson Institute, Flinders University, CSIRO, the Monash Institute of Medical Engineering and Associate Professor Anna Rosamilia, head of the Pelvic Floor Unit at Monash Health.
Project leader Professor Caroline Gargett, from the Endometrial Stem Cell Biology group at the Hudson Institute of Medical Research, says the ultimate aim is to restore quality of life to women with POP, and to prevent the condition from occurring in younger women.
“We know that women and clinicians are calling out for safer, more effective treatments and we are working to deliver these options,” she says.
“We have shown in preclinical studies that endometrial stem cells differentiate into the type of cells that are required in the vaginal walls.
“We believe endometrial stem cells have real potential in treating pelvic organ prolapse. The cells have been shown to produce factors that ‘trick’ the body or modify the immune response to one of healing, rather than scarring, which helps to repair the damage.”
POP develops when tissues, pelvic floor muscles and ligaments that support the pelvic organs (bladder, uterus and bowel), become damaged, usually in childbirth, causing organs to shift or ‘drop’ into the vagina or even outside the body.
This can lead to debilitating symptoms, including poor bladder or bowel control and pain during sex. This may profoundly affect a woman’s quality of life.
POP may be exacerbated by other factors such as age, ethnicity, the number of times a woman has given birth, obesity and their family genetics.
It is exacerbated by menopause – one in two postmenopausal women who have had children will experience POP, compared to one in four women generally.
At Flinders University, Professor John Arkwright’s laboratory at Tonsley is developing a novel fibre optic probe to better monitor and classify damage to the pelvic floor region.
The Flinders researchers are developing a fibre-optic pressure device to help develop a method to more accurately diagnose areas of weakness associated with POP and better target stem cell treatments to those areas.
“Accurate diagnosis of the areas of weakness associated with POP will better manage the new treatment method,” Arkwright says.
Clinical trials are not expected for at least another three to five years. Before the treatment can reach women, it must first undergo a rigorous process of preclinical testing to show long-term safety and efficacy, as well as research ethics and Therapeutic Goods Administration approvals.
Current treatment options for POP are limited. Up until recently, many Australian women with POP underwent surgical insertion of transvaginal mesh implants – synthetic strips of materials that sit between a prolapsed organ (bladder, bowel and uterus) and the vaginal walls to hold the organ in place.
Around the world, safety concerns have been raised around these meshes due to reports of adverse effects in women such as pain, scarring and organ perforation.
The Therapeutic Goods Administration in Australia conducted a review of the scientific evidence and clinical studies of transvaginal mesh products for POP, and found the benefits of these meshes do not outweigh the risks to patients.
In November 2017, the Therapeutic Goods Administration announced it would remove transvaginal mesh products for the sole purpose of treating pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods.
A class action is also underway on behalf of around 700 Australian women who are seeking redress for adverse effects they claim have occurred as a result of transvaginal mesh implants.
A Senate Enquiry on the issue is expected to report on its findings on March 20, 2018.