Autologous Cell Therapy for Female Stress Urinary Incontinence

NCT01008943 | Completed Phase 2 Results

• 1 other identifier: 09-013
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• 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, approximately 6 weeks

• 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

• 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

• Number of Participants That Experienced AMDC Product-related 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

Study Arms (1)

1

EXPERIMENTAL

Biological: Autologous Muscle Derived Cells

Interventions

Autologous Muscle Derived Cells BIOLOGICAL

Urethral injection of autologous muscle-derived cells

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SUI with normal detrusor activity confirmed with urodynamics
• Bladder capacity \>200 ml
• Incontinence has not shown any improvement for at least -6 months
• Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

You may not qualify if:

• Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
• Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
• Uncontrolled diabetes
• Pregnant, lactating, or plans to become pregnant during course of the study
• Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
• Current or acute conditions involving cystitis or urethritis
• Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures

Sponsors & Collaborators

• Cook MyoSite: lead

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3 M5, Canada

Location

Related Links

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

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Scott Snyder, PhD, Director of Clinical Science and Biostatistics
• Organization: Cook Medical

ssnyder@medinst.com

765-463-7537

Study Officials

• Lesley K. Carr, MD

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: June 2, 2010
• Primary Completion: September 21, 2012
• Study Completion: September 21, 2012
• Last Updated: July 1, 2021
• Results First Posted: November 3, 2015

Record last verified: 2021-06

Locations

CA (2)