Trial Outcomes & Findings for Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome (NCT NCT03779711)

Last Updated: 2025-07-08

Results Overview

Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

95 participants

Primary outcome timeframe

baseline, 3 months post-Stage II surgery

Results posted on

2025-07-08

Participant Flow

Subjects were recruited from May 2019 through January 2022 from the following eight sites: Children's Hospital Colorado, Children's Hospital Los Angeles, Children's Hospital of Alabama, Children's Hospital of Philadelphia, Children's Hospitals and Clinics of Minnesota - Minneapolis, Cincinnati Children's Hospital Medical Center, Ochsner Medical Center Jefferson, and Oklahoma University Medical Center.

Participant milestones

Participant milestones
Measure	Treatment Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Overall Study STARTED	50	45
Overall Study COMPLETED	40	41
Overall Study NOT COMPLETED	10	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

2 treatment subjects did not have a baseline FAC measurement recorded, due to poor Echo image.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=50 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=45 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Total n=95 Participants Total of all reporting groups
Age, Continuous	5.1 months STANDARD_DEVIATION 1.5 • n=50 Participants	5.8 months STANDARD_DEVIATION 2.2 • n=45 Participants	5.4 months STANDARD_DEVIATION 1.9 • n=95 Participants
Sex: Female, Male Female	11 Participants n=50 Participants	20 Participants n=45 Participants	31 Participants n=95 Participants
Sex: Female, Male Male	39 Participants n=50 Participants	25 Participants n=45 Participants	64 Participants n=95 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=50 Participants	11 Participants n=45 Participants	14 Participants n=95 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=50 Participants	28 Participants n=45 Participants	71 Participants n=95 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=50 Participants	6 Participants n=45 Participants	10 Participants n=95 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants	0 Participants n=45 Participants	0 Participants n=95 Participants
Race (NIH/OMB) Asian	3 Participants n=50 Participants	1 Participants n=45 Participants	4 Participants n=95 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants	0 Participants n=45 Participants	0 Participants n=95 Participants
Race (NIH/OMB) Black or African American	3 Participants n=50 Participants	3 Participants n=45 Participants	6 Participants n=95 Participants
Race (NIH/OMB) White	36 Participants n=50 Participants	29 Participants n=45 Participants	65 Participants n=95 Participants
Race (NIH/OMB) More than one race	3 Participants n=50 Participants	2 Participants n=45 Participants	5 Participants n=95 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=50 Participants	10 Participants n=45 Participants	15 Participants n=95 Participants
Fractional Area Change (%)	41.2 percentage of area STANDARD_DEVIATION 6.4 • n=48 Participants • 2 treatment subjects did not have a baseline FAC measurement recorded, due to poor Echo image.	41.3 percentage of area STANDARD_DEVIATION 5.8 • n=45 Participants • 2 treatment subjects did not have a baseline FAC measurement recorded, due to poor Echo image.	41.2 percentage of area STANDARD_DEVIATION 6.1 • n=93 Participants • 2 treatment subjects did not have a baseline FAC measurement recorded, due to poor Echo image.
Troponin T (ng/mL)	0.065 ng/mL STANDARD_DEVIATION 0.185 • n=42 Participants • 8 treated and 4 control subjects did not have baseline Troponin, due to site error in collecting the values.	0.037 ng/mL STANDARD_DEVIATION 0.052 • n=41 Participants • 8 treated and 4 control subjects did not have baseline Troponin, due to site error in collecting the values.	0.051 ng/mL STANDARD_DEVIATION 0.136 • n=83 Participants • 8 treated and 4 control subjects did not have baseline Troponin, due to site error in collecting the values.

PRIMARY outcome

Timeframe: baseline, 3 months post-Stage II surgery

Population: All enrolled subjects with both a baseline and 3-month Fractional Area Change value as assessed by Echocardiogram.

Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.

Outcome measures

Outcome measures
Measure	Treatment n=40 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=41 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)	-2.2258 percentage of area Interval -3.8988 to -0.5527	-2.5116 percentage of area Interval -4.1641 to -0.859

PRIMARY outcome

Timeframe: baseline, 3 months post-Stage II surgery

Population: All enrolled subjects with both baseline and 3-month circumferential strain values as assessed by echocardiogram.

Right ventricular cardiac function as measured by echocardiogram that includes studies for circumferential strain. Measured by percent.

Outcome measures

Outcome measures
Measure	Treatment n=30 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=35 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Right Ventricular Cardiac Function Measured by Circumferential Strain.	1.3412 percentage of area Interval -0.3101 to 2.9925	0.1704 percentage of area Interval -1.3582 to 1.699

PRIMARY outcome

Timeframe: baseline, 3 months post-Stage II surgery

Population: All enrolled subjects with both baseline and 3-month longitudinal strain values as assessed by echocardiogram.

Right ventricular cardiac function as measured by echocardiogram that includes studies for longitudinal strain. Measured by percent.

Outcome measures

Outcome measures
Measure	Treatment n=39 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=39 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Right Ventricular Cardiac Function Measured by Longitudinal Strain.	0.5394 percentage of area Interval -0.06073 to 1.686	-1.2407 percentage of area Interval -2.3873 to -0.09402

PRIMARY outcome

Timeframe: baseline, 12 months post-Stage II surgery

Population: All enrolled subjects with both baseline and 12-month fractional area changes values, as assessed by echocardiogram.

Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.

Outcome measures

Outcome measures
Measure	Treatment n=33 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=32 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)	-3.8975 percentage of area Interval -5.6808 to -2.1143	-4.4310 percentage of area Interval -6.2419 to -2.6201

SECONDARY outcome

Timeframe: baseline pre-op, hospital discharge from Stage II surgery (an average of 1-6 weeks)

Population: All enrolled subjects with both baseline and discharge fractional area change values, as assessed by echocardiogram.

Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.

Outcome measures

Outcome measures
Measure	Treatment n=46 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=43 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)	-1.8109 percentage of area Interval -3.6744 to 0.05259	-3.0902 percentage of area Interval -5.0176 to -1.1628

SECONDARY outcome

Timeframe: 1-month post Stage II surgery

Population: All enrolled subjects.

Cumulative days of hospitalization per patient following discharge for the Stage II surgical repair.

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=45 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Cumulative Days of Hospitalization	13.2 days Standard Deviation 9.6	13.3 days Standard Deviation 9.1

SECONDARY outcome

Timeframe: baseline, 3-months post Stage II surgery

Population: All enrolled subjects with weight values at both baseline and 3-months.

Change in weight between baseline and 3-months post Stage II surgery. Weight as measured by scale provided as part of standard of care by subject's provider. Measured at home by subject's caregiver using the same scale for every home measurement of body weight. Caregivers will be instructed by the site to use the same scale for every home measurement of body weight. Scales will vary based on the institution's standard name/type used.

Outcome measures

Outcome measures
Measure	Treatment n=44 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=39 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Weight	1.4 kg Standard Deviation 1.3	1.3 kg Standard Deviation 0.7

SECONDARY outcome

Timeframe: baseline, 3-months post Stage II surgery

Population: All enrolled subjects with heart rate values at both baseline and 3-months.

Change in heart rate between baseline and 3-months post Stage II surgery. Heart rate as measured at home by subject's caregiver as standard of care per subject's provider. Caregivers will be instructed by the site staff on the best way to perform.

Outcome measures

Outcome measures
Measure	Treatment n=43 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=38 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Heart Rate	3.2 beats per minute Standard Deviation 14.5	4.6 beats per minute Standard Deviation 21.2

SECONDARY outcome

Timeframe: baseline, 3-months post Stage II surgery

Population: All enrolled subjects with oxygen saturation values at both baseline and 3-months.

Change in oxygen saturation between baseline and 3-months post Stage II surgery. Oxygen saturation as measured at home by subject's caregiver using the pulse oximetry device provided as standard of care by subject's provider. Caregivers will be instructed by the site to use the same pulse oximetry device for every home measurement of oxygen saturation.

Outcome measures

Outcome measures
Measure	Treatment n=40 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=36 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Oxygen Saturation	4.9 percentage of saturation Standard Deviation 7.3	5.7 percentage of saturation Standard Deviation 6.6

SECONDARY outcome

Timeframe: baseline, every 6 months post-Stage II surgery

Population: Enrolled subjects with weight values available at each 6-month follow-up visit.

Weight as measured by scale provided as part of standard of care by subject's provider. Measured at home by subject's caregiver using the same scale for every home measurement of body weight. Caregivers will be instructed by the site to use the same scale for every home measurement of body weight. Scales will vary based on the institution's standard name/type used.

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=45 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Weight Baseline	6.1 kg Standard Deviation 0.80	6.2 kg Standard Deviation 1.20
Change in Weight 6-months	8.1 kg Standard Deviation 1.35	8.4 kg Standard Deviation 1.27
Change in Weight 12-months	9.7 kg Standard Deviation 1.38	9.6 kg Standard Deviation 1.30
Change in Weight 18-months	11.0 kg Standard Deviation 1.49	10.9 kg Standard Deviation 1.64
Change in Weight 24-months	12.0 kg Standard Deviation 1.92	12.2 kg Standard Deviation 1.82

SECONDARY outcome

Timeframe: 3-months post-surgery

Population: All enrolled subjects.

Changes in arrhythmia and heart failure medications will be recorded by caregiver on the concomitant medication diary throughout the subject's participation in the study starting at the time of consent.

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=45 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Change in Arrhythmia and Heart Failure Medication ACE Inhibitor · Same	5 Participants	7 Participants
Change in Arrhythmia and Heart Failure Medication Thiazide diuretic · Decrease	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication ACE Inhibitor · Decrease	1 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication ACE Inhibitor · Increase	13 Participants	14 Participants
Change in Arrhythmia and Heart Failure Medication ACE Inhibitor · Not Prescribed	31 Participants	24 Participants
Change in Arrhythmia and Heart Failure Medication Aldosterone receptor antagonis · Decrease	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Aldosterone receptor antagonis · Increase	5 Participants	4 Participants
Change in Arrhythmia and Heart Failure Medication Aldosterone receptor antagonis · Not Prescribed	45 Participants	41 Participants
Change in Arrhythmia and Heart Failure Medication Aldosterone receptor antagonis · Same	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Antiarrythmic Class IC · Decrease	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Antiarrythmic Class IC · Increase	0 Participants	1 Participants
Change in Arrhythmia and Heart Failure Medication Antiarrythmic Class IC · Not Prescribed	48 Participants	44 Participants
Change in Arrhythmia and Heart Failure Medication Antiarrythmic Class IC · Same	2 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Antiarrythmic Class III · Decrease	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Antiarrythmic Class III · Increase	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Antiarrythmic Class III · Not Prescribed	46 Participants	45 Participants
Change in Arrhythmia and Heart Failure Medication Antiarrythmic Class III · Same	4 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication B-blocker · Decrease	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication B-blocker · Increase	2 Participants	1 Participants
Change in Arrhythmia and Heart Failure Medication B-blocker · Not Prescribed	46 Participants	41 Participants
Change in Arrhythmia and Heart Failure Medication B-blocker · Same	2 Participants	3 Participants
Change in Arrhythmia and Heart Failure Medication Endotelin receptor antagonist · Decrease	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Endotelin receptor antagonist · Increase	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Endotelin receptor antagonist · Not Prescribed	49 Participants	44 Participants
Change in Arrhythmia and Heart Failure Medication Endotelin receptor antagonist · Same	1 Participants	1 Participants
Change in Arrhythmia and Heart Failure Medication Loop diuretic · Decrease	1 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Loop diuretic · Increase	25 Participants	20 Participants
Change in Arrhythmia and Heart Failure Medication Loop diuretic · Not Prescribed	21 Participants	20 Participants
Change in Arrhythmia and Heart Failure Medication Loop diuretic · Same	3 Participants	5 Participants
Change in Arrhythmia and Heart Failure Medication Na+/K+ ATPase inhibitor · Decrease	1 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication Na+/K+ ATPase inhibitor · Increase	10 Participants	4 Participants
Change in Arrhythmia and Heart Failure Medication Na+/K+ ATPase inhibitor · Not Prescribed	34 Participants	32 Participants
Change in Arrhythmia and Heart Failure Medication Na+/K+ ATPase inhibitor · Same	5 Participants	9 Participants
Change in Arrhythmia and Heart Failure Medication PDE-3 inhibitor · Decrease	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication PDE-3 inhibitor · Increase	1 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication PDE-3 inhibitor · Not Prescribed	49 Participants	45 Participants
Change in Arrhythmia and Heart Failure Medication PDE-3 inhibitor · Same	0 Participants	0 Participants
Change in Arrhythmia and Heart Failure Medication PDE-5 inhibitor · Decrease	0 Participants	3 Participants
Change in Arrhythmia and Heart Failure Medication PDE-5 inhibitor · Increase	10 Participants	10 Participants
Change in Arrhythmia and Heart Failure Medication PDE-5 inhibitor · Not Prescribed	39 Participants	28 Participants
Change in Arrhythmia and Heart Failure Medication PDE-5 inhibitor · Same	1 Participants	4 Participants
Change in Arrhythmia and Heart Failure Medication Thiazide diuretic · Increase	5 Participants	3 Participants
Change in Arrhythmia and Heart Failure Medication Thiazide diuretic · Not Prescribed	45 Participants	42 Participants
Change in Arrhythmia and Heart Failure Medication Thiazide diuretic · Same	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Stage III surgery pre-op, approx. 4 years

The number of research subjects eligible for Stage III surgical repair

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Stage III surgery pre-op, approx. 4 years

The number of days between Stage II surgery and listed on cardiac transplantation list.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, Stage III surgery pre-op

Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: approx 4 years

The number of days between Stage II surgery and death occurrence

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3-months post Stage II surgery

Population: All enrolled subjects.

Cumulative days of hospitalization per patient following discharge for the Stage II surgical repair.

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=45 Participants Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Cumulative Days of Hospitalization	20.7 days Standard Deviation 26.0	15.6 days Standard Deviation 15.9

Adverse Events

Treatment

Serious events: 38 serious events

Other events: 48 other events

Deaths: 4 deaths

Control

Serious events: 27 serious events

Other events: 45 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Clint Hagen

Mayo Clinic

Phone: (507) 577-1764

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment n=50 participants at risk Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery . Autologous (self) mononuclear cells derived from umbilical cord blood: The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Control n=45 participants at risk Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study. Stage II Surgical repair: This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
Gastrointestinal disorders Abdominal Distension	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Metabolism and nutrition disorders Acidosis	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Renal and urinary disorders Acute kidney injury	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Psychiatric disorders Agitation	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Vascular disorders Arterial thromboembolism	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Atrioventricular block complete	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Infections and infestations Bacteremia	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other Specify	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	4.4% 2/45 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.
Infections and infestations Bronchial infection	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	4.4% 2/45 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Cardiac arrest	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	4.4% 2/45 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Cardiac disorders - Other specify	38.0% 19/50 • Number of events 28 • 4 years Specific Adverse Event Terms will not be reported.	15.6% 7/45 • Number of events 11 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Chylothorax	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	4.4% 2/45 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Chylous ascites	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Colonic perforation	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Cyanosis	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Death NOS	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Metabolism and nutrition disorders Dehydration	8.0% 4/50 • Number of events 4 • 4 years Specific Adverse Event Terms will not be reported.	4.4% 2/45 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Depressed level of consciousness	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Diarrhea	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Ear and labyrinth disorders Ear and labyrinth disorders - Other specify	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	4.4% 2/45 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.
General disorders Edema face	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Encephalopathy	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Infections and infestations Enterocolitis infectious	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Injury, poisoning and procedural complications Fall	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
General disorders Fever	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
General disorders Flu like symptoms	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Gastric hemorrhage	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Gastritis	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Gastroesophageal reflux disease	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Gastrointestinal disorders - Other specify	10.0% 5/50 • Number of events 9 • 4 years Specific Adverse Event Terms will not be reported.	6.7% 3/45 • Number of events 3 • 4 years Specific Adverse Event Terms will not be reported.
General disorders General disorders - Other specify	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Heart failure	8.0% 4/50 • Number of events 4 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Vascular disorders Hypertension	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Metabolism and nutrition disorders Hypoglycemia	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Vascular disorders Hypotension	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Hypoxia	18.0% 9/50 • Number of events 15 • 4 years Specific Adverse Event Terms will not be reported.	11.1% 5/45 • Number of events 5 • 4 years Specific Adverse Event Terms will not be reported.
Infections and infestations Infections and infestations - Other specify	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	11.1% 5/45 • Number of events 5 • 4 years Specific Adverse Event Terms will not be reported.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other specify	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Intracranial hemorrhage	2.0% 1/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Injury, poisoning and procedural complications Intraoperative cardiac injury	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Ischemia cerebrovascular	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Laryngospasm	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Infections and infestations Mediastinal infection	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other specify	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
General disorders Multi-organ failure	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Muscle weakness left-sided	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Nervous system disorders - Other specify	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.0% 3/50 • Number of events 3 • 4 years Specific Adverse Event Terms will not be reported.	6.7% 3/45 • Number of events 3 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Recurrent laryngeal nerve palsy	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Renal and urinary disorders Renal and urinary disorders - Other specify	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Respiratory failure	8.0% 4/50 • Number of events 5 • 4 years Specific Adverse Event Terms will not be reported.	6.7% 3/45 • Number of events 3 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other specify	16.0% 8/50 • Number of events 14 • 4 years Specific Adverse Event Terms will not be reported.	20.0% 9/45 • Number of events 15 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Right ventricular dysfunction	10.0% 5/50 • Number of events 5 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Seizure	6.0% 3/50 • Number of events 3 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Infections and infestations Sepsis	2.0% 1/50 • Number of events 3 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Sinus bradycardia	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Sinus tachycardia	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Spasticity	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Nervous system disorders Spinal cord compression	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Supraventricular tachycardia	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Surgical and medical procedures Surgical and medical procedures - Other specify	8.0% 4/50 • Number of events 4 • 4 years Specific Adverse Event Terms will not be reported.	4.4% 2/45 • Number of events 5 • 4 years Specific Adverse Event Terms will not be reported.
Vascular disorders Thromboembolic event	8.0% 4/50 • Number of events 5 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Tricuspid valve disease	2.0% 1/50 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	6.0% 3/50 • Number of events 3 • 4 years Specific Adverse Event Terms will not be reported.	4.4% 2/45 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.
Cardiac disorders Ventricular tachycardia	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Gastrointestinal disorders Vomiting	6.0% 3/50 • Number of events 3 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Investigations Weight loss	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Injury, poisoning and procedural complications Wound complication	2.0% 1/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/50 • 4 years Specific Adverse Event Terms will not be reported.	2.2% 1/45 • Number of events 1 • 4 years Specific Adverse Event Terms will not be reported.
Injury, poisoning and procedural complications Wound infection	4.0% 2/50 • Number of events 2 • 4 years Specific Adverse Event Terms will not be reported.	0.00% 0/45 • 4 years Specific Adverse Event Terms will not be reported.