Autologous Cell Therapy for Female Stress Urinary Incontinence

• Sponsor: Cook MyoSite (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01008943
• Collaborator: (none)
• Enrollment: 16
• Locations: 2
• Arm: 1
• Actual Duration (Months): 27.7
• Patients Per Site: 8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence	Biological: Autologous Muscle Derived Cells	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence
• Actual Study Start Date: Jun 2, 2010
• Actual Primary Completion Date: Sep 21, 2012
• Actual Study Completion Date: Sep 21, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Biological: Autologous Muscle Derived Cells; Urethral injection of autologous muscle-derived cells

Outcome Measures

Primary Outcome Measures

1. Number of Participants That Experienced Biopsy Procedure-related Adverse Events [at biopsy or between biopsy and treatment, approximately 6 weeks]

   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.

2. Number of Participants That Experienced Injection Procedure-related Adverse Events [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.

3. Injection Procedure-related Adverse Events [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.

4. Number of Participants That Experienced AMDC Product-related Events [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foothills Medical Centre	Calgary	Alberta	Canada	T2N2T9
2	Sunnybrook Health Sciences Center	Toronto	Ontario	Canada	M4N 3 M5

Sponsors and Collaborators

• Cook MyoSite

Investigators

• Principal Investigator: Lesley K. Carr, MD, Sunnybrook Health Sciences Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Cook MyoSite
• ClinicalTrials.gov Identifier: NCT01008943
• Other Study ID Numbers: 09-013
• First Posted: Nov 6, 2009
• Last Update Posted: Jul 1, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress

Study Results

Participant Flow

Arm/Group Title	Autologous Muscle-Derived Cells (AMDC)
Arm/Group Description	Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
Period Title: Overall Study
STARTED	16
COMPLETED	15
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Autologous Muscle-Derived Cells (AMDC)
Arm/Group Description	Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
Overall Participants	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61 (2)
Sex: Female, Male (Count of Participants)
Female	16 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Description	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.
Time Frame	at biopsy or between biopsy and treatment, approximately 6 weeks

Outcome Measure Data

Analysis Population Description

One patient experienced procedural dizziness.

Arm/Group Title	Autologous Muscle-Derived Cells (AMDC)
Arm/Group Description	Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
Measure Participants	16
Measure Biopsies	22
Number [participants]	1 6.3%

2. Primary Outcome

Title	Number of Participants That Experienced Injection Procedure-related Adverse Events
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Muscle-Derived Cells (AMDC)
Arm/Group Description	Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
Measure Participants	16
Number [participants]	6 37.5%

3. Primary Outcome

Title	Injection Procedure-related Adverse Events
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Muscle-Derived Cells (AMDC)
Arm/Group Description	Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
Measure Participants	16
Abdominal pain lower	2
Dysuria	4
Micturition urgency	1
Urinary tract infection	1

4. Primary Outcome

Title	Number of Participants That Experienced AMDC Product-related Events
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Autologous Muscle-Derived Cells (AMDC)
Arm/Group Description	Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
Measure Participants	16
Number [participants]	0 0%

Adverse Events

Time Frame	12 months
Arm/Group Title	Autologous Muscle-Derived Cells (AMDC)
Arm/Group Description	Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
All Cause Mortality
	Autologous Muscle-Derived Cells (AMDC)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Autologous Muscle-Derived Cells (AMDC)
	Affected / at Risk (%)	# Events
Total	1/16 (6.3%)
Injury, poisoning and procedural complications
Fibula fracture	1/16 (6.3%)	1
Other (Not Including Serious) Adverse Events
	Autologous Muscle-Derived Cells (AMDC)
	Affected / at Risk (%)	# Events
Total	12/16 (75%)
Gastrointestinal disorders
After AMDC treatment: Abdominal pain lower	2/16 (12.5%)	2
General disorders
After AMDC treatment: Generalised oedema	1/16 (6.3%)	1
Injury, poisoning and procedural complications
After biopsy, before AMDC: Procedural dizziness	1/16 (6.3%)	1
Investigations
After AMDC treatment: Blood creatinine increased	1/16 (6.3%)	1
After AMDC treatment: Blood urea increased	1/16 (6.3%)	1
After AMDC treatment: Blood urine	1/16 (6.3%)	1
After AMDC treatment: Hemoglobin decreased	1/16 (6.3%)	1
After AMDC treatment: Platelet count decreased	1/16 (6.3%)	1
After AMDC treatment: Protein urine present	1/16 (6.3%)	1
After AMDC treatment: Residual urine volume increased	1/16 (6.3%)	1
After AMDC treatment: White blood cell count increase	2/16 (12.5%)	2
Renal and urinary disorders
After AMDC treatment: Dysuria	5/16 (31.3%)	5
After AMDC treatment: Micturition urgency	1/16 (6.3%)	1
After biopsy, before AMDC: Urethral dilatation	1/16 (6.3%)	1
After AMDC treatment: Urinary retention	2/16 (12.5%)	2
After AMDC treatment: Urinary tract infection	3/16 (18.8%)	3
Reproductive system and breast disorders
After AMDC treatment: Menorrhagia	1/16 (6.3%)	1
After AMDC treatment: Menstruation irregular	1/16 (6.3%)	1
Respiratory, thoracic and mediastinal disorders
After AMDC treatment: Influenza	1/16 (6.3%)	1
Surgical and medical procedures
After AMDC treatment: Ophthalmologic treatment	1/16 (6.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.