Stress Urinary IncontinencePhase 2NCT00847535
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
A Phase 2 study testing autologous muscle cell injection in people with Stress Urinary Incontinence and Cell Therapy, run by Cook MyoSite at 3 sites in 2 countries.
Trial summary
This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence, Cell Therapy
- What is being tested?
- autologous muscle cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 9 Oct 2008to 2 Nov 2011
- Phase
- Phase 2
- 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
- Patient has SUI with normal detrusor activity confirmed with urodynamics
- Patient has bladder capacity >200 mL
- Patient's incontinence has not shown any improvement for at least -6 months
- Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
Who cannot join
- Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
- Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
- Patient has uncontrolled diabetes
- Patient is pregnant, lactating, or plans to become pregnant during the course of the study
- Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
- Patient has current or acute conditions involving cystitis or urethritis
- Patient is scheduled to receive radiation treatment to the vicinity
- Patients with a history of radiation treatment to the urethra or adjacent structures
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Wm Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.
This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence, Cell Therapy
- Being tested
- autologous muscle cell injection
- 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.
autologous muscle cell injectionBiological
Injection of autologous muscle cells
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Transurethral dose escalation Receives: Biological: autologous muscle cell injection |
| 2 | Other | Periurethral dose escalation Receives: Biological: autologous muscle cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.
All biopsy procedure-related events either self-resolved or were easily treated.
Measured: at biopsy or between biopsy and treatment
Biopsy Procedure-related Adverse Events
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.
All biopsy procedure-related events either self-resolved or were easily treated.
Measured: at biopsy or between biopsy and treatment
Number of Participants That Experienced Injection Procedure-related Adverse Events
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.
All injection procedure-related events self-resolved or were easily treated.
Measured: 30 days
Injection Procedure-related Adverse Events
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.
All injection procedure-related events self-resolved or were easily treated.
Measured: 30 days
Number of Participants That Experienced AMDC Product-related Adverse Events
If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.
No adverse events reported during the study were adjudicated as AMDC product-related.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study start9 Oct 2008
- Primary completion2 Nov 2011
- Study completion2 Nov 2011
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kenneth Peters, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847535
- Sponsor's protocol ID
- 08-006
- Other IDs
- IND1
- Status last verified
- Aug 2023
- First submitted
- 18 Feb 2009
- Last updated
- 8 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.
- ClinicalTrials.gov ID
- NCT00847535
- Acronym / sponsor ID
- 08-006
- Conditions
- Stress Urinary Incontinence, Cell Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2008 (actual)
- Primary completion
- 2 Nov 2011 (actual)
- Study completion
- 2 Nov 2011 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 1 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Biological: autologous muscle cell injectionTransurethral dose escalation |
| 2 | Other | Biological: autologous muscle cell injectionPeriurethral dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has SUI with normal detrusor activity confirmed with urodynamics
- Patient has bladder capacity >200 mL
- Patient's incontinence has not shown any improvement for at least -6 months
- Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
Key exclusion criteria (8 listed)
- Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
- Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
- Patient has uncontrolled diabetes
- Patient is pregnant, lactating, or plans to become pregnant during the course of the study
- Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
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 |
|---|---|---|
| autologous muscle cell injectionInjection of autologous muscle cells | Biological | 1, 2 |
Primary outcome
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Time frame: at biopsy or between biopsy and treatment
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.
Biopsy Procedure-related Adverse Events
Time frame: at biopsy or between biopsy and treatment
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.
Number of Participants That Experienced Injection Procedure-related Adverse Events
Time frame: 30 days
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Injection Procedure-related Adverse Events
Time frame: 30 days
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received. All injection procedure-related events self-resolved or were easily treated.
Number of Participants That Experienced AMDC Product-related Adverse Events
Time frame: 12 months
If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product. No adverse events reported during the study were adjudicated as AMDC product-related.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Autologous muscle derived cells for treatment of stress urinary incontinence in womenLink provided by the sponsor.
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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.
Kenneth Peters, MD principal investigator
Corewell Health East
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous muscle cell injection in people with Stress Urinary Incontinence and Cell Therapy, run by Cook MyoSite at 3 sites in 2 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 4 inclusion and 8 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 1 Jan 2014). 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?
Number of Participants That Experienced Biopsy Procedure-related Adverse Events (time frame: at biopsy or between biopsy and treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2023.