Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

• ClinicalTrials.gov Identifier: NCT01893138
• Recruitment Status: Completed
• First Posted: July 8, 2013
• Results First Posted: January 5, 2023
• Last Update Posted: January 5, 2023
• Sponsor: Cook MyoSite
• Information provided by (Responsible Party): Cook MyoSite

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stress Urinary Incontinence
• Interventions: Other: Placebo; Biological: Iltamiocel
• Enrollment: 311

Participant Flow

Recruitment Details

Pre-assignment Details

311 subjects were enrolled (underwent biopsy procedure) and 297 subjects underwent study treatment with iltamiocel (199 subjects) or placebo (98 subjects). Analysis population is based on 297 subjects that underwent study treatment. At randomization, participants stratified by presence or absence of prior incontinence surgery and by < 10 or ≥10 stress incontinence episodes over 3 day diary at screening.

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Period Title: Double-Blind Period
Started	199	98
Injection	199	98
1 Month Follow-Up	199	97
3 Month Follow-Up	199	97
6 Month Follow-Up	198	97
12 Month Follow-Up	198	97
Completed	198	97
Not Completed	1	1
Reason Not Completed
Withdrawal by Subject	1	1
Period Title: Open Label - Unblinded Period
Started	198	97
Open Label Period	166	97
Iltamiocel Injection [1]	0	92
2 Year Follow-Up	166	87
Completed	166	87
Not Completed	32	10
Reason Not Completed
Lack of Efficacy	9	0
Lost to Follow-up	4	3
Withdrawal by Subject	18	7
Adverse Event	1	0
[1] No additional treatment for iltamiocel arm. Subjects originally randomized to placebo received single, open-label iltamiocel injection.

Baseline Characteristics

Arm/Group Title		Iltamiocel	Placebo	Total
Arm/Group Description		AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.	Total of all reporting groups
Overall Number of Baseline Participants		199	98	297
Baseline Analysis Population Description		Women ≥18 years or older with stress-predominant urinary incontinence.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	199 participants	98 participants	297 participants
		54.1 (10.9)	55.0 (10.7)	54.4 (10.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	199 participants	98 participants	297 participants
	Female	199 100.0%	98 100.0%	297 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	199 participants	98 participants	297 participants
	Hispanic or Latino	3 1.5%	5 5.1%	8 2.7%
	Not Hispanic or Latino	196 98.5%	93 94.9%	289 97.3%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	199 participants	98 participants	297 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	5 2.5%	0 0.0%	5 1.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	5 2.5%	3 3.1%	8 2.7%
	White	184 92.5%	89 90.8%	273 91.9%
	More than one race	2 1.0%	1 1.0%	3 1.0%
	Unknown or Not Reported	3 1.5%	5 5.1%	8 2.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	199 participants	98 participants	297 participants
Belgium		2	1	3
United States		193	94	287
Germany		4	3	7
Stress Incontinence Episodes Over 3 Day Diary [1]; Mean (Standard Deviation); Unit of measure: Stress leaks
	Number Analyzed	199 participants	98 participants	297 participants
		14.2 (9.8)	15 (14.2)	14.5 (11.4)
		[1] Measure Description: Participant recorded number of stress leaks over 3 days in electronic diary.
24 Hour Pad Test Weight [1]; Mean (Standard Deviation); Unit of measure: Grams
	Number Analyzed	199 participants	98 participants	297 participants
		47.6 (91.8)	40.9 (52.8)	45.2 (81.1)
		[1] Measure Description: A test in which the participant wears specific absorbent pads dispensed by the clinic. The pads are weighed to record the pre-test weight prior to dispensing to the participant. The participant must wear the absorbent pads for 24 hours. The participant returns the used absorbent pads to the clinic, and the clinic records the post-test weight to determine urinary leakage for the 24 hour period. The difference in weights represent the amount of urine leaked in which 24 hour pad weight = total weight of pads after test period - total weight of pads prior to test period.
Incontinence Quality of Life (IQOL) Assessment -Total Score [1]; Mean (Standard Deviation); Unit of measure: Scores on scales
	Number Analyzed	199 participants	98 participants	297 participants
		59.0 (21.0)	59.5 (20.2)	59.2 (20.0)
		[1] Measure Description: The I-QOL questionnaire is a validated, 22-item tool used to assess quality of life (QOL) of women with urinary incontinence, focused on avoidance and limiting behavior, psychosocial impacts, and social embarrassment. Score scale is 0-100; increased score indicates improvement.. Scored 0 to100, with higher scores indicating a better QOL
7-Item Incontinence Impact Questionnaire - Short Form (IIQ-7) [1]; Mean (Standard Deviation); Unit of measure: Scores on scales
	Number Analyzed	199 participants	98 participants	297 participants
		44.4 (20.9)	43.7 (21.8)	44.2 (21.2)
		[1] Measure Description: The IIQ-7 questionnaire is a validated, 7-item tool used to assess the impact of urinary incontinence on health-related quality of life, focused on physical activity, social relationships, travel, and emotional health. Scored 0 to 100, lower scores indicate better quality of life (QOL).
6-Item Urogenital Distress Inventory Score - Short Form (UDI-6) [1]; Mean (Standard Deviation); Unit of measure: Scores on scales
	Number Analyzed	199 participants	98 participants	297 participants
		38.5 (16)	40.5 (18.4)	39.2 (16.8)
		[1] Measure Description: This questionnaire consists of 6 questions focused on symptoms related to stress urinary incontinence, detrusor overactivity, and bladder outlet obstruction. Score scale is 0-75; decreased score indicates improvement.
Global Quality of Life Assessment (GQOL) [1]; Mean (Standard Deviation); Unit of measure: Scores on scales
	Number Analyzed	199 participants	98 participants	297 participants
		5.7 (1.0)	5.6 (1.1)	5.7 (1.0)
		[1] Measure Description: This questionnaire consists of 1 question focused on satisfaction with condition. Score scale is 0-6; decreased score indicates improvement.
Incontinence Severity Index (ISI) [1]; Mean (Standard Deviation); Unit of measure: Scores on scales
	Number Analyzed	199 participants	98 participants	297 participants
		7.6 (2.4)	7.4 (2.8)	7.5 (2.5)
		[1] Measure Description: The ISI is a questionnaire consisting of two questions which assesses the frequency and quantity of urine leakage. Score scale is 0-12; decreased score indicates improvement.

Outcome Measures

1. Primary Outcome

Title	Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
Description	[Not Specified]
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

All participants with baseline and 12 month 3 day diary data

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	198	97
Measure Type: Count of Participants; Unit of Measure: Participants
	103 52.0%	52 53.6%

2. Secondary Outcome

Title	Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months
Description	[Not Specified]
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

All participants with baseline and 12 month 3 day diary data

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	198	97
Measure Type: Count of Participants; Unit of Measure: Participants
	73 36.9%	30 30.9%

3. Secondary Outcome

Title	Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months
Description	[Not Specified]
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

All participants with baseline and 12 month diary data

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	198	97
Measure Type: Count of Participants; Unit of Measure: Participants
	53 26.8%	22 22.7%

4. Secondary Outcome

Title	Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months
Description	[Not Specified]
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

All participants with baseline and 12 month 3 day diary data

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	198	97
Mean (Standard Deviation); Unit of Measure: stress leaks
	-5.8 (11)	-4.9 (13.5)

5. Other Pre-specified Outcome

Title	Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency
Description	Spearman's correlation used for analysis
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

All participants with baseline and 12 month diary data

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	198	96
Measure Type: Number; Unit of Measure: correlation coefficient
Association of IQOL improvement with stress incontinence episode reduction at 12 months	-0.556	-0.456
Association of IIQ-7 improvement with stress incontinence episode reduction at 12 months	0.522	0.442
Association of UDI-6 improvement with stress incontinence episode reduction at 12 months	0.408	0.433
Association of GQOL improvement with stress incontinence episode reduction at 12 months	0.537	0.422
Association of ISI improvement with stress incontinence episode reduction at 12 months	0.529	0.599

6. Other Pre-specified Outcome

Title	Treatment Durability at 24 Months
Description	Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months
Time Frame	Baseline, 12 months, and 24 months after injection with iltamiocel

Outcome Measure Data

Analysis Population Description

All participants who received iltamiocel treatment during the double-blind period and with 12-month and 24-month stress incontinence episode frequency (SIEF) diary data. Participants who received placebo treatment in the double-blind period are not included due to receiving iltamiocel treatment in the open-label period after unblinding or were exited from the study.

Arm/Group Title		Iltamiocel
Arm/Group Description:		AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.
Overall Number of Participants Analyzed		199
Measure Type: Count of Participants; Unit of Measure: Participants
Participants that had ≥ 50% reduction in stress incontinence episodes at Month 12 and Month 24 data	Number Analyzed	89 participants
		80 89.9%
Participants that had ≥ 75% reduction in stress incontinence episodes at Month 12 and Month 24 data	Number Analyzed	65 participants
		50 76.9%
Participants that had ≤1 stress incontinence episodes at Month 12 and Month 24 data	Number Analyzed	45 participants
		36 80.0%

7. Post-Hoc Outcome

Title	Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only)
Description	Participants with a history of prior SUI surgery with baseline and 12 month diary data.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	50	25
Measure Type: Count of Participants; Unit of Measure: Participants
	20 40.0%	4 16.0%

8. Post-Hoc Outcome

Title	Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months (Prior Surgery Participants Only)
Description	Participants with a history of prior SUI surgery with baseline and 12 month diary data.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	50	25
Measure Type: Count of Participants; Unit of Measure: Participants
	14 28.0%	3 12.0%

9. Post-Hoc Outcome

Title	Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only)
Description	Participants with a history of prior SUI surgery with baseline and 12 month diary data.
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	50	25
Mean (Standard Deviation); Unit of Measure: stress leaks
	-6.7 (14.5)	-4.5 (11.5)

10. Post-Hoc Outcome

Title	Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency (Prior Surgery Participants Only)
Description	Spearman's correlation used for analysis
Time Frame	Baseline and 12 months

Outcome Measure Data

Analysis Population Description

All participants with prior surgery and baseline and 12 month diary data

Arm/Group Title	Iltamiocel	Placebo
Arm/Group Description:	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.	Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.
Overall Number of Participants Analyzed	50	25
Measure Type: Number; Unit of Measure: correlation coefficient
Association of IQOL improvement with stress incontinence episode reduction at 12 months	-0.489	-0.460
Association of IIQ-7 improvement with stress incontinence episode reduction at 12 months	0.427	0.542
Association of UDI-6 improvement with stress incontinence episode reduction at 12 months	0.424	0.604
Association of GQOL improvement with stress incontinence episode reduction at 12 months	0.561	0.190
Association of ISI improvement with stress incontinence episode reduction at 12 months	0.426	0.476

11. Post-Hoc Outcome

Title	Treatment Durability at 24 Months (Prior Surgery Participants)
Description	Treatment durability defined as participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained response at 24 months
Time Frame	Baseline, 12 months, and 24 months after injection with iltamiocel

Outcome Measure Data

Analysis Population Description

Prior surgery participants who received iltamiocel treatment during the double-blind period with 12-month and 24-month stress incontinence episode frequency (SIEF) diary data. Prior surgery participants who received placebo treatment in the double-blind period are not included due to receiving iltamiocel treatment in the open-label period after unblinding or were exited from the study.

Arm/Group Title		Iltamiocel
Arm/Group Description:		AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.
Overall Number of Participants Analyzed		53
Measure Type: Count of Participants; Unit of Measure: Participants
Participants that had ≥ 50% reduction in stress incontinence episodes at Month 12 and Month 24 data	Number Analyzed	22 participants
		19 86.4%
Participants that had ≥ 75% reduction in stress incontinence episodes at Month 12 and Month 24 data	Number Analyzed	18 participants
		12 66.7%
Participants that had ≤1 stress incontinence episodes at Month 12 and Month 24 data	Number Analyzed	13 participants
		11 84.6%

Adverse Events

Time Frame	12 month double-blind period and open label unblinded period from month 12 to 24
Adverse Event Reporting Description	Collection at biopsy, injection, 1 month, 3 months, 6 months, and 12 months post-treatment for double-blind period for comparison between treatment arms prior to unblinding investigator and participant. Subjects unblinded after 12 month visit, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.
Arm/Group Title	Iltamiocel - Double-Blind Period		Placebo - Double-Blind Period		Iltamiocel - Unblinded Period		Placebo Receiving Open Label Iltamiocel in Unblinded Period
Arm/Group Description	AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10^6 cells.		Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control.		Subjects who received iltamiocel in double-blind period. No additional treatment for iltamiocel arm in unblinded period.		Subjects who received placebo in double-blind period and elected to receive iltamiocel injection in unblinded period. Single intraurethral injection of 150 x 10^6 cells.
All-Cause Mortality
	Iltamiocel - Double-Blind Period		Placebo - Double-Blind Period		Iltamiocel - Unblinded Period		Placebo Receiving Open Label Iltamiocel in Unblinded Period
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/199 (0.00%)		0/98 (0.00%)		0/198 (0.00%)		0/92 (0.00%)
Serious Adverse Events
	Iltamiocel - Double-Blind Period		Placebo - Double-Blind Period		Iltamiocel - Unblinded Period		Placebo Receiving Open Label Iltamiocel in Unblinded Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/199 (5.53%)		9/98 (9.18%)		12/198 (6.06%)		4/92 (4.35%)
Cardiac disorders
Acute myocardial infarction † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Coronary artery dissection † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Coronary artery disease † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Gastrointestinal disorders
Colitis † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Gastritis † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Pancreatitis † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
General disorders
Chest pain † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Systemic inflammatory response syndrome † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Fatigue † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	0/198 (0.00%)	0	1/92 (1.09%)	1
Immune system disorders
Hypersensitivity † 1 [1]	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Infections and infestations
Sepsis † 1	1/199 (0.50%)	1	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Staphylococcal infection † 1	2/199 (1.01%)	2	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Pneumonia † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Pyelonephritis † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Urinary tract infection † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Viral infection † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Bacteremia † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Influenza † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Infectious pleural effusion † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	0/198 (0.00%)	0	1/92 (1.09%)	1
Pneumonia staphylococcal † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	0/198 (0.00%)	0	1/92 (1.09%)	1
Injury, poisoning and procedural complications
Meniscus injury † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	1/198 (0.51%)	1	0/92 (0.00%)	0
Pelvic fracture † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Procedural Pain † 1 [2]	2/199 (1.01%)	2	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Fall † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Intentional Overdose † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Subdural haematoma † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Osteoarthritis † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Pain in extremity † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Scoliosis † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Spondylolisthesis † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Arthralgia † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Arthritis † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Arthropathy † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Joint lock † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Breast cancer † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Intraductal proliferative breast lesion † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Invasive ductal breast carcinoma † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Uterine leiomyoma † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Nervous system disorders
Transient ischaemic attack † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Psychiatric disorders
Major depression † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Suicide attempt † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Panic attack † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	0/198 (0.00%)	0	1/92 (1.09%)	1
Renal and urinary disorders
Nephrolithiasis † 1	0/199 (0.00%)	0	1/98 (1.02%)	1	0/198 (0.00%)	0	0/92 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	1/198 (0.51%)	1	1/92 (1.09%)	1
Atelectasis † 1	1/199 (0.50%)	1	0/98 (0.00%)	0	0/198 (0.00%)	0	0/92 (0.00%)	0
Hypoxia † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	0/198 (0.00%)	0	1/92 (1.09%)	1
Pulmonary embolism † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Vascular disorders
Hypertension † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
Malignant hypertension † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	0/198 (0.00%)	0	1/92 (1.09%)	1
Subgaleal haematoma † 1	0/199 (0.00%)	0	0/98 (0.00%)	0	1/198 (0.51%)	1	0/92 (0.00%)	0
1 Term from vocabulary, MedDRA version 16.1; † Indicates events were collected by systematic assessment; [1] Related to Iltamiocel and Injection Procedure; [2] Related to Biopsy Procedure
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Iltamiocel - Double-Blind Period		Placebo - Double-Blind Period		Iltamiocel - Unblinded Period		Placebo Receiving Open Label Iltamiocel in Unblinded Period
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	84/199 (42.21%)		28/98 (28.57%)		21/198 (10.61%)		22/92 (23.91%)
General disorders
Injection site pain † 1	10/199 (5.03%)	11	1/98 (1.02%)	1	0/198 (0.00%)	0	1/92 (1.09%)	1
Infections and infestations
Urinary tract infection † 1	36/199 (18.09%)	53	14/98 (14.29%)	19	14/198 (7.07%)	16	10/92 (10.87%)	12
Sinusitis † 1	11/199 (5.53%)	11	1/98 (1.02%)	1	4/198 (2.02%)	4	2/92 (2.17%)	2
Musculoskeletal and connective tissue disorders
Back pain † 1	7/199 (3.52%)	8	5/98 (5.10%)	6	2/198 (1.01%)	2	3/92 (3.26%)	3
Renal and urinary disorders
Dysuria † 1	20/199 (10.05%)	20	7/98 (7.14%)	8	1/198 (0.51%)	1	6/92 (6.52%)	6
1 Term from vocabulary, MedDRA version 16.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Ron Jankowski, PhD
• Organization: Cook MyoSite, Inc.
• Phone: 412-963-7380
• EMail: Ron.Jankowski@CookMyosite.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Antosh DD, High R, Brown HW, Oliphant SS, Abed H, Philip N, Grimes CL. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Am J Obstet Gynecol. 2017 Nov;217(5):605.e1-605.e5. doi: 10.1016/j.ajog.2017.07.017. Epub 2017 Jul 20.

• Responsible Party: Cook MyoSite
• ClinicalTrials.gov Identifier: NCT01893138
• Other Study ID Numbers: 13-003
• First Submitted: July 2, 2013
• First Posted: July 8, 2013
• Results First Submitted: September 12, 2022
• Results First Posted: January 5, 2023
• Last Update Posted: January 5, 2023