Regenerative medicine firm ACell has enrolled the first patient for a US Phase IV clinical trial to assess the safety and long-term effectiveness of its MatriStem pelvic floor matrix device.
A total of 162 subjects will be recruited for the study in order to assess MatriStem’s ability to treat pelvic organ prolapse compared with native tissue repair.
The multi-centre, prospective, non-randomised trial will measure post-operative pelvic pain, quality of life and long-term need for retreatment.
The objective of the trial is to show that treatment with MatriStem Pelvic Floor Matrix device is effective to treat native tissue repair, as evaluated through anatomic and subjective assessments over a 36-month follow up period.
More than 300,000 cases of pelvic organ prolapse are treated surgically every year in the US. It is estimated that 20% of women will undergo one pelvic surgery in their lifetime.
The Phase IV trial is part of the company’s plan to carry out postmarket surveillance for MatriStem pelvic floor matrix in response to the 522 Order issued to all manufacturers of transvaginal pelvic meshes by the US Food and Drug Administration in January 2012.
ACell CEO Jim DeFrancesco said: "ACell is proud to be partnering with an impressive group of surgeons to demonstrate the safety and effectiveness of MatriStem devices in pelvic floor repair."
The first patient in the trial was enrolled at Princeton Urogynecology under urogynecologist Heather van Raalte.
"Pelvic organ prolapse is a significant quality of life issue for hundreds of thousands of women," Raalte said
"This study will contribute to a better understanding of how physicians can help these patients achieve positive outcomes."