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A double-blind, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of autologous muscle derived cells in female subjects with stress urinary incontinence

  • Urology - Original Paper
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Abstract

Purpose

The purpose of the study was to assess safety and efficacy of autologous muscle derived cells for urinary sphincter repair (AMDC-USR) in female subjects with predominant stress urinary incontinence.

Methods

A randomized, double-blind, multicenter trial examined intra-sphincteric injection of 150 × 106 AMDC-USR versus placebo in female subjects with stress or stress predominant, mixed urinary incontinence. AMDC-USR products were generated from vastus lateralis needle biopsies. Subjects were randomized 2:1 to receive AMDC-USR or placebo and 1:1 to receive 1 or 2 treatments (6 months after the first). Primary outcome was composite of ≥ 50% reduction in stress incontinence episode frequency (IEF), 24-h or in-office pad weight tests at 12 months. Other outcome data included validated subject-recorded questionnaires. Subjects randomized to placebo could elect to receive open-label AMDC-USR treatment after 12 months. Subject follow-up was up to 2 years.

Results

AMDC-USR was safe and well-tolerated with no product-related serious adverse events or discontinuations due to adverse events. Interim analysis revealed an unexpectedly high placebo response rate (90%) using the composite primary outcome which prevented assessment of treatment effect as designed and thus enrollment was halted at 61% of planned subjects. Post hoc analyses suggested that more stringent endpoints lowered placebo response rates and revealed a possible treatment effect.

Conclusions

Although the primary efficacy finding was inconclusive, these results inform future trial design of AMDC-USR to identify clinically meaningful efficacy endpoints based on IEF reduction, understanding of placebo response rate, and refinement of subject selection criteria to more appropriately align with AMDC-USR’s proposed mechanism of action.

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Acknowledgements

The authors would like to thank the subjects for their participation in the trial and site investigators and personnel for their contributions in conducting the study. The authors would also like to thank the following people for their assistance in preparation of this manuscript: Kelly Cardello, Jenna Dale, Walter Mitchel, Angela Caron-Montgomery at Cook MyoSite, Inc. and Patricia Kultgen and Anna Parks at Cook Research Incorporated.

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Authors and Affiliations

  1. Cook MyoSite, Inc., 105 Delta Drive, 15238, Pittsburgh, PA, USA

    Ron J. Jankowski, Christopher Carlson & Ryan Pruchnic

  2. Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, QC, Canada

    Le Mai Tu

  3. Foothills Medical Centre, Calgary, AB, Canada

    Magali Robert

  4. Southern Alberta Institute of Urology, Calgary, AB, Canada

    Kevin Carlson

  5. Victoria Gynecology and Continence Clinic, British Columbia, VIC, Canada

    David Quinlan

  6. Praxisklinik Urologie Rhein–Ruhr, Mülheim, Germany

    Andreas Eisenhardt

  7. Cook Research Incorporated, West Layfette, IN, USA

    Min Chen & Scott Snyder

  8. Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA

    Michael Chancellor

  9. Vanderbilt University Medical Center, Nashville, TN, USA

    Roger Dmochowski & Melissa R. Kaufman

  10. Sunnybrook Health Sciences Centre, Toronto, ONT, Canada

    Lesley Carr

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  1. Ron J. Jankowski
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Corresponding author

Correspondence to Ron J. Jankowski.

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Conflict of interest

Dr. Ron Jankowski, Mr. Ryan Pruchnic, and Dr. Christopher Carlson are employees of the sponsor, Cook MyoSite Inc. Dr. Le Mai Tu is a site investigator and receives funding from the sponsor for an Investigator Initiated trial. Dr. Michael Chancellor, a William Beaumont Hospital Urologist working on this study, was one of the inventors of this stem cell process. Dr. Chancellor receives royalty payments for the stem cell process and payments for consulting from Cook-MyoSite, the sponsor of the study. Dr. Roger Dmochowski is a site investigator and a consultant for Avadel Pharmaceuticals, Axsome Therapeutics, BlueWind Medical, GTx and Cook MyoSite, Inc. Dr. Melissa Kaufman receives support from the sponsor, Cook MyoSite, Inc., as a global clinical investigator, has participated in Advisory Boards with Boston Scientific, is a member of the Data Safety Monitoring Board for Valencia Technologies and is on the Editorial Board at the Journal of Urology. Dr. Lesley Carr is a site investigator, receives support for research and travel from the sponsor, Cook MyoSite, Inc. and has participated in Advisory Board meetings for the sponsor. Dr. Carr also serves on Speakers Boards for Astellas, Allergan, Pfizer, Duchesney USA and Ferring Pharmaceuticals. Dr. Magali Robert, Dr. Kevin Carlson, and Dr. Andreas Eisenhardt are site investigators and declare no conflicts of interest. Dr. Scott Snyder and Dr. Min Chen are employees of Cook Research Incorporated.

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Informed consent was obtained from each subject before performing any screening procedures by the Principal Investigator, co-Investigator, or research coordinator at each site.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Jankowski, R.J., Tu, L.M., Carlson, C. et al. A double-blind, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of autologous muscle derived cells in female subjects with stress urinary incontinence. Int Urol Nephrol 50, 2153–2165 (2018). https://doi.org/10.1007/s11255-018-2005-8

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