Phase 2
Completed N=64
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Stress Urinary Incontinence · Cell Therapy
Source: ClinicalTrials.gov NCT00847535 ↗
Enrolled (actual)
64
Serious AEs
12.1%
Results posted
Jan 2014
Primary outcomePrimary: Number of Participants That Experienced Biopsy Procedure-related Adverse Events — 3 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Experienced Biopsy Procedure-related Adverse Events |
3 | — |
| PRIMARY Biopsy Procedure-related Adverse Events |
2; 1; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants That Experienced Injection Procedure-related Adverse Events |
8 | — |
| PRIMARY Injection Procedure-related Adverse Events |
3; 3; 2; 2; 1; 1 | — |
| PRIMARY Number of Participants That Experienced AMDC Product-related Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00847535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.