An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence

Stress Urinary Incontinence Clinical Trial

Official title:

Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847535
• Other study ID #: 08-006
• Secondary ID: IND1
• Status: Completed
• Phase: Phase 2
• Start date: October 9, 2008
• Est. completion date: November 2, 2011

Study information

• Verified date: August 2023
• Source: Cook MyoSite
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2, 2011
• Est. primary completion date: November 2, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cell Therapy
• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Biological:
• autologous muscle cell injection
Injection of autologous muscle cells

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Center	Toronto	Ontario
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Wm Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at biopsy or between biopsy and treatment
Primary	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.	at biopsy or between biopsy and treatment
Primary	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.	30 days
Primary	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.	30 days
Primary	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.	12 months

External Links

•   Autologous muscle derived cells for treatment of stress urinary incontinence in women