Stress Urinary IncontinencePhase 3NCT01893138
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
A Phase 3 study testing Iltamiocel in people with Stress Urinary Incontinence, run by Cook MyoSite at 29 sites in 3 countries.
Trial summary
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Iltamiocel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 311 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 21 Nov 2013to 10 Nov 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
Who cannot join
- Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
- Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
- Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
- Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
- Patient has more than 2 episode of awakening to void during normal sleeping hours.
- Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study.
Show all 10Show fewer
- Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
- Patient refuses to provide written informed consent.
- Patient is not at least 18 years of age.
- Patient is not available for the follow-up evaluations as required by the protocol.
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
United States26 sites
The American Association of Female Pelvic Medicine Specialists
Agoura Hills, California, 91301
Emory University
Atlanta, Georgia, 30033
Medical University of South Carolina
Charleston, South Carolina, 29425
McKay Urology
Charlotte, North Carolina, 28207
The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45242
Cleveland Clinic
Cleveland, Ohio, 44195
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Female Pelvic Medicine & Urogynecology Institute of Michigan
Grand Rapids, Michigan, 49503
Mercy Health Saint Mary's Campus
Grand Rapids, Michigan, 49503
Greenville Health System
Greenville, South Carolina, 29607
Methodist Urology Associates
Houston, Texas, 77030
IU Health Physicians Urogynecology
Indianapolis, Indiana, 46202
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
NYU Urology Associates
New York, New York, 10016
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Mayo Clinic Arizona Phoenix Campus
Phoenix, Arizona, 85054
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Premier Medical Group of the Hudson Valley PC
Poughkeepsie, New York, 12601
William Beaumont Hospital
Royal Oak, Michigan, 48073
Benaroya Research Institute at Virginia Mason
Seattle, Washington, 98101
Sanford Female Pelvic Medicine and Reconstructive Surgery Clinic
Sioux Falls, South Dakota, 57105
NorthShore University HealthSystem
Skokie, Illinois, 60076
Stanford University
Stanford, California, 94304
Montefiore Medical Center
The Bronx, New York, 10467
Cleveland Clinic Florida
Weston, Florida, 33331
Germany2 sites
Universitätsklinikum Essen
Essen, 45147
Praxisklinik Urologie Rhein-Ruhr (PUR/R)
Mülheim, 45468
About this study
Official title: A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Read the detailed description
Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Placebo, Iltamiocel
- Keywords
- Urinary Incontinence, Stress, Tissue Therapy (Cell Therapy), Transplantation, Autologous
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo control is the vehicle solution used for the study product.
IltamiocelBiological
Also called Autologous muscle-derived cells (AMDC)
AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo control is the vehicle solution used for the study product. Receives: Other: Placebo |
| Iltamiocel | Experimental | AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. Receives: Biological: Iltamiocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
Measured: Baseline and 12 months
Secondary outcomes (3)
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months
Measured: Baseline and 12 months
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months
Measured: Baseline and 12 months
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2013 (estimated)
- Study start21 Nov 2013
- Primary completion1 Nov 2019
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Melissa Kaufman, M.D., Ph.D., Principal investigator, Vanderbilt University Medical Center, Department of Urologic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893138
- Sponsor's protocol ID
- 13-003
- Status last verified
- Dec 2022
- First submitted
- 2 Jul 2013
- Last updated
- 5 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaufman MR, Goldman HB, Chermansky CJ, Dmochowski R, Kennelly MJ, Peters KM, Quiroz LH, Bennett JB, Thomas S, Marguet CG, Benson KD, Lee UJ, Sokol ER, Wolter CE, Katz DM, Tarnay CM, Antosh D, Heit MH, Rehme C, Karram M, Snyder S, Canestrari E, Jankowski RJ, Chancellor MB. Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial. Neurourol Urodyn. 2024 Nov;43(8):2290-2299. doi: 10.1002/nau.25588. Epub 2024 Sep 16.
PubMed 39282854Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.
PubMed 28734829
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Controlled Trial Comparing the Safety and Efficacy of AMDC-USR With Placebo in Female Subjects With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01893138
- Acronym / sponsor ID
- 13-003
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Stress, Tissue Therapy (Cell Therapy), Transplantation, Autologous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2013 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 8 Jul 2013 (estimated)
- Results
- Posted 5 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.
Detailed description
Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo control is the vehicle solution used for the study product. |
| Iltamiocel | Experimental | Biological: IltamiocelAMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.
Key exclusion criteria (10 listed)
- Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
- Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
- Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
- Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
- Patient has more than 2 episode of awakening to void during normal sleeping hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo control is the vehicle solution used for the study product. | Other | Placebo |
| IltamiocelAlso: Autologous muscle-derived cells (AMDC)AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells. | Biological | Iltamiocel |
Primary outcome
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
Time frame: Baseline and 12 months
3 secondary outcomes
Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months
Time frame: Baseline and 12 months
Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months
Time frame: Baseline and 12 months
Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39282854Kaufman MR, Goldman HB, Chermansky CJ, Dmochowski R, Kennelly MJ, Peters KM, Quiroz LH, Bennett JB, Thomas S, Marguet CG, Benson KD, Lee UJ, Sokol ER, Wolter CE, Katz DM, Tarnay CM, Antosh D, Heit MH, Rehme C, Karram M, Snyder S, Canestrari E, Jankowski RJ, Chancellor MB. Iltamiocel Autologous Cell Therapy for the Treatment of Female Stress Urinary Incontinence: A Double-Blind, Randomized, Stratified, Placebo-Controlled Trial. Neurourol Urodyn. 2024 Nov;43(8):2290-2299. doi: 10.1002/nau.25588. Epub 2024 Sep 16.
- Derived from this study: PubMed 28734829Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Kaufman, M.D., Ph.D. principal investigator
Vanderbilt University Medical Center, Department of Urologic Surgery
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iltamiocel in people with Stress Urinary Incontinence, run by Cook MyoSite at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01893138, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.