Trial Outcomes & Findings for Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery (NCT NCT02291432)

NCT ID: NCT02291432

Last Updated: 2021-11-01

Results Overview

Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 25 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2021-11-01

Participant Flow

Participant milestones

Measure	AMDC-USR Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Study STARTED	25
Overall Study Muscle Biopsy	25
Overall Study AMDC Injection	23
Overall Study 1-Month Follow Up	23
Overall Study 3-Month Follow Up	23
Overall Study 6-Month Follow Up	23
Overall Study 12-Month Follow Up	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	AMDC-USR Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Autologous Cell Therapy for Stress Urinary Incontinence in Males Following Prostate Surgery

Baseline characteristics by cohort

Measure	AMDC-USR n=25 Participants Single intraurethral injection of 150 x 10\^6 autologous muscle-derived cells (AMDCs).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	67 years n=5 Participants
Age, Customized Participant Age	67.2 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	25 Participants n=5 Participants
Urinary Incontinence Type Pure Stress Urinary Incontinence	4 Participants n=5 Participants
Urinary Incontinence Type Mixed Urinary Incontinence, Stress Predominant	17 Participants n=5 Participants
Urinary Incontinence Type Mixed Urinary Incontinence, Urge Predominant	4 Participants n=5 Participants
24-hour Pad Test Weight	109.1 grams n=5 Participants
Incontinence Quality of Life (I-QOL)	59.1 scores on scales n=5 Participants
International Consultation on Incontinence Questionnaire (ICIQ)	13 scores on scales n=5 Participants
International Prostate Symptom Score (IPSS)	9 scores on scales n=5 Participants
International Index of Erectile Function (IIEF)	13 scores on scales n=5 Participants
Patient Global Impression of Severity (PGI-S) Questionnaire Normal	0 Participants n=5 Participants
Patient Global Impression of Severity (PGI-S) Questionnaire Mild	8 Participants n=5 Participants
Patient Global Impression of Severity (PGI-S) Questionnaire Moderate	13 Participants n=5 Participants
Patient Global Impression of Severity (PGI-S) Questionnaire Severe	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: All subjects enrolled (biopsied)

Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery.

Outcome measures

Measure	AMDC-USR n=25 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events Study product-related serious adverse events	0 events
Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events Study Product-related adverse events	2 events
Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events Injection procedure-related adverse events	0 events
Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events Biopsy procedure-related adverse events	12 events

PRIMARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: All subjects injected

Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Volume of Post-void Residual (PVR) Urine Post void residual volume 1 month	0 millileters Interval 0.0 to 52.0
Volume of Post-void Residual (PVR) Urine Post void residual volume 3 months	0 millileters Interval 0.0 to 37.0
Volume of Post-void Residual (PVR) Urine Post void residual volume 6 months	0 millileters Interval 0.0 to 142.0
Volume of Post-void Residual (PVR) Urine Post void residual volume 12 months	0 millileters Interval 0.0 to 22.0

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: All subjects injected

Change in the amount of urine leakage from baseline was assessed by 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) 24 hour pad weight at 1 month	101.2 grams Interval 5.3 to 674.3
Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) 24 hour pad weight at 3 months	59.5 grams Interval 18.1 to 357.0
Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) 24 hour pad weight at 6 months	104.9 grams Interval 9.2 to 359.5
Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) 24 hour pad weight at 12 months	85.7 grams Interval 13.5 to 319.7

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: All subjects injected

Change in the amount of urine leakage from baseline was assessed by a 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) ≥50% reduction in 24 hour pad weight at 1 month	2 Participants
Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) ≥50% reduction in 24 hour pad weight at 3 months	4 Participants
Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) ≥50% reduction in 24 hour pad weight at 6 months	4 Participants
Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) ≥50% reduction in 24 hour pad weight at 12 months	7 Participants

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: All subjects injected

Median change from baseline in patient-reported quality of life (QOL) was assessed by the Incontinence Quality of Life (I-QOL) questionnaire at 1, 3, 6 and 12 months post-treatment. The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to100, with higher scores indicating a better QOL.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire Change in I-QOL total score at 1 month	-6.8 points Interval -14.8 to 6.8
Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire Change in I-QOL total score at 3 months	0 points Interval -27.3 to 9.1
Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire Change in I-QOL total score at 6 months	-9.1 points Interval -37.5 to 12.5
Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire Change in I-QOL total score at 12 months	-9.1 points Interval -36.4 to 14.8

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6, and 12 months

Population: All subjects injected

Median change from baseline in patient-reported symptom severity was assessed by the International Consultation on Incontinence Questionnaire (ICIQ) questionnaire at 1, 3, 6, and 12 months post-treatment. The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) Change in ICIQ score at 1 month	0 scores on a scale Interval -2.0 to 7.0
Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) Change in ICIQ score at 3 months	0 scores on a scale Interval -3.0 to 7.0
Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) Change in ICIQ score at 6 months	0 scores on a scale Interval -3.0 to 7.0
Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) Change in ICIQ score at 12 months	1 scores on a scale Interval -1.0 to 16.0

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6, and 12 months

Population: All subjects injected

Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the International Prostate Symptom Score (I-PSS) questionnaire. The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire Change in I-PSS score at 3 months	1 scores on a scale Interval -8.0 to 10.0
Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire Change in I-PSS score at 1 month	1 scores on a scale Interval -4.0 to 8.0
Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire Change in I-PSS score at 6 months	1 scores on a scale Interval -6.0 to 15.0
Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire Change in I-PSS score at 12 months	1 scores on a scale Interval -3.0 to 10.0

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: All subjects injected

Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Severity (PGI-S) questionnaire. The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. Percentages of participants in each category were determined at each visit.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 6 months · Mild	9 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 12 months · Moderate	13 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 1 month · Normal	1 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 1 month · Mild	3 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 1 month · Moderate	13 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 1 month · Severe	6 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 3 months · Normal	0 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 3 months · Mild	8 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 3 months · Moderate	12 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 3 months · Severe	3 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 6 months · Normal	0 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 6 months · Moderate	11 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 6 months · Severe	3 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 12 months · Normal	1 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 12 months · Mild	6 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire PGI-S score at 12 months · Severe	3 Participants

SECONDARY outcome

Timeframe: 1, 3, 6, and 12 months

Population: All subjects injected

Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Improvement (PGI-I) questionnaire. The PGI-I was a global assessment of symptom severity in which participants selected the following ratings: 1-Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, and 7-Very much worse. Percentages of participants in each category were determined at each visit.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 1 month · Very much better	1 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 1 month · Much better	0 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 1 month · A little better	4 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 1 month · No change	18 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 1 month · A little worse	0 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 3 months · Very much better	0 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 3 months · Much better	1 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 3 months · A little better	12 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 3 months · No change	9 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 3 months · A little worse	1 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 6 months · Very much better	0 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 6 months · Much better	3 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 6 months · A little better	11 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 6 months · No change	7 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 6 months · A little worse	2 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 12 months · Very much better	0 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 12 months · Much better	4 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 12 months · A little better	11 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 12 months · No change	5 Participants
Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire PGI-I score at 12 months · A little worse	3 Participants

SECONDARY outcome

Timeframe: Baseline, 1, 3, 6, and 12 months

Population: All subjects injected

SUI and ED can be comorbidities that develop following prostate surgery; median change from baseline in patient-reported Erectile Dysfunction (ED) was assessed by the 5-Item International Index of Erectile Function (IIEF-5). The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction. Scored from 5 to 25, with lower scores indicating less ED symptoms.

Outcome measures

Measure	AMDC-USR n=23 Participants Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire Change in IEEF-5 score at 1 month	0 scores on a scale Interval -9.0 to 8.0
Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire Change in IEEF-5 score at 3 months	0 scores on a scale Interval -7.0 to 8.0
Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire Change in IEEF-5 score at 6 months	0 scores on a scale Interval -11.0 to 4.0
Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire Change in IEEF-5 score at 12 months	0 scores on a scale Interval -8.0 to 7.0

Adverse Events

AMDC-USR

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	AMDC-USR n=25 participants at risk Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Cardiac disorders Myocardial infarction	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Infections and infestations Pneumonia	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Musculoskeletal and connective tissue disorders Spinal column stenosis	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Musculoskeletal and connective tissue disorders Spondylolisthesis	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Nervous system disorders Cerebrovascular accident	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Renal and urinary disorders Nephrolithiasis	4.0% 1/25 • Number of events 2 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.

Other adverse events

Measure	AMDC-USR n=25 participants at risk Single intraurethral injection of 150 x 10\^6 Autologous Muscle-Derived Cells (AMDCs)
Renal and urinary disorders Micturition urgency	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Renal and urinary disorders Pollakiuria	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Injury, poisoning and procedural complications Post procedural contusion	8.0% 2/25 • Number of events 2 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Injury, poisoning and procedural complications Post procedural swelling	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Injury, poisoning and procedural complications Procedural hypotension	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Injury, poisoning and procedural complications Procedural nausea	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Injury, poisoning and procedural complications Procedural pain	12.0% 3/25 • Number of events 3 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • Number of events 2 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Nervous system disorders Hypoaesthesia	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Skin and subcutaneous tissue disorders Erythema	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Skin and subcutaneous tissue disorders Hyperhidrosis	4.0% 1/25 • Number of events 1 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Gastrointestinal disorders Abdominal Pain	8.0% 2/25 • Number of events 2 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Infections and infestations Sinusitis	8.0% 2/25 • Number of events 7 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Injury, poisoning and procedural complications Fall	8.0% 2/25 • Number of events 2 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
Infections and infestations Laceration	8.0% 2/25 • Number of events 2 • Adverse events were monitored from enrollment through study exit - 24 months total. All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.

Additional Information

Ron Jankowski, PhD

Cook MyoSite Incorporated

Phone: 412-963-7380

Email: Ron.Jankowski@CookMyosite.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60