How the study was conducted
Researchers randomly assigned 24 menopausal rats to receive as a topical intravaginal application a daily dose of a solution containing either hydrogel at two different concentrations–6 or 8 milligrams per milliliter–or collagen or saline. After 14 days of treatment, researchers took samples of vaginal tissues and analyzed them.
They found that in rats that had received the hydrogel treatment, vaginal tissues appeared closer to those of pre-menopausal animals. In addition, treatment with the hydrogel led to an increase in smooth muscle thickness. Researchers also found that the 8 milligram dose seemed to be more effective, likely due to a higher concentration of extracellular matrix proteins.
Researchers sampled tissues from the animals in the first three days of treatment and found that the hydrogel was present not only in the surface layer but also in the muscular layer of the vaginal wall. They found that macrophages, which are part of the immune system, in particular responded to the hydrogel with increases in the kind of macrophage that helps with tissue repair.
Researchers also didn’t find any safety concerns or adverse effects on the rats during the study.
Next steps
Next steps include testing various concentrations of the hydrogel in a larger preclinical study over a longer period of time. The researchers also need to test whether the hydrogel can be administered less frequently–twice or three times a week rather than daily.
“We need a multidisciplinary approach to solving women’s health issues,” said Dr. Alperin, urogynecology and reconstructive pelvic surgery specialist at UC San Diego Health.
The research was supported in that part by the NIH National Institute on Aging and the NIH National Institute of Child Health and Human Development.
Christman is a cofounder of Ventrix Bio. Inc., which is commercializing a similar hydrogel technology for treating heart disease.
Development of a vaginal extracellular matrix hydrogel for combatting genitourinary syndrome of menopause
Emma I. Zelus and Karen L Christman, Shu-Chien Gene Lay Department of Bioengineering, Sanford Consortium for Regenerative Medicine and Sanford Stem Cell Institute
Marianna Alperin, Sanford Consortium for Regenerative Medicine and UC San Diego Department of Obstetrics, Gynecology and Reproductive Sciences
Jacqueline Grime, UC San Diego Division of Biological Sciences
Anthony Saviola, Maxwell McCabe and Kirk C. Hansen, Department of Biochemistry and Molecular Genetics, University of Colorado
Alperin and Christman are co-corresponding authors
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