Efficacy and Safety of Targeted Intramyocardial Delivery... | NCT01508910

ID	Type	Description	Link
RENEW Study	Other Identifier	Caladrius Biosciences, Inc.

Label	Type	Description	Intervention Names
Treatment Arm	Experimental	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis	Biological: Auto-CD34+ cells
Active Control Arm	Placebo Comparator	Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis	Biological: Placebo: Diluent used to suspend Auto-CD34+ cells
Unblinded Standard of Care (SOC) Arm	Other	No study-related procedures will be performed.	Other: Standard of care

Name	Type	Description	Arm Group Labels	Other Names
Auto-CD34+ cells	Biological	10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells	Treatment Arm

Measure	Description	Time Frame
Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol	Baseline (BL) is the average of the two total exercise times measured during the screening period.	Baseline and 12 month visit

Measure	Description	Time Frame
Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit	Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.	Baseline and 12 month visit
Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Male or female participants who are 21 to 80 years of age at the time of signing the informed consent.
Participants with Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.
Participants without control of their angina symptoms in spite of maximal tolerated doses of anti-angina drugs. Participants must be on optimal therapy for their angina and must have been on a stable anti-anginal medication regimen for at least 4 weeks before signing the informed consent form.
Participants with obstructive coronary disease unsuitable for conventional revascularization due to unsuitable anatomy or comorbidity as determined at the site and confirmed by an independent adjudication committee.
Participants must have evidence of inducible myocardial ischemia.
Participants must experience angina episodes.
Participants must be able to complete 2 exercise tolerance tests on the treadmill within 3 weeks of randomization.
If female of childbearing potential, subject must not be pregnant and agree to employ adequate birth control measures for the duration of the study.

Main Exclusion Criteria:

Cardiovascular hospitalization within 60 days prior to potential study enrollment. Participant has had a successful or partially successful coronary artery bypass graft (CABG) within 6 months or PCTA within 60 days of potential study enrollment.
Participant has had a placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure within 180 days of potential study enrollment.
Participant has documented stroke or transient ischemic attacks (TIAs) within 60 days of potential study enrollment.
Participant has a history of moderate to severe aortic stenosis; or severe aortic insufficiency; or severe mitral stenosis; or severe mitral insufficiency.
Participant has a prosthetic aortic valve or a mechanical mitral valve replacement.
Participant has severe co-morbidity associated with a reduction in life expectancy to less than 3 years as a result of chronic medical illnesses.
Participants with cancer are excluded with the following exceptions:
- Subjects with in-situ non-melanoma skin cancer or in-situ cervical cancer are not excluded.
- Participants that have been cancer free for >= 5 years as determined by their oncologist are not excluded. Subjects with a prior history of stem cell transplant for cancer are excluded no matter how long they have been cancer-free.
Participants with a history of leukemia or other bone marrow disease.
Participant has sickle cell disease or sickle cell trait.
Participants with proliferative retinopathy.
Participants with Hb A1c > 9%.
Participant has platelet counts >10% above the upper limit of normal (ULN) or platelet counts < 70,000.
Participant has a hematocrit < 30% prior to potential study enrollment.
Participant has a serum creatinine > 2.5 mg/dL prior to potential study enrollment.
Participant tests positive for HIV, hepatitis B, or hepatitis C, or is on chronic immunosuppressive medications, or has had a previous stem cell transplant.
Participant has a known contraindication to Neupogen (filgrastim) or G-CSF.
Participant was previously enrolled in an active treatment group of cell therapy trials for cardiovascular disease including any phase of CD34+ stem cell trials.
Left ventricular (LV) thickness of < 7 mm in the target areas of injection as measured by during a 2-D echocardiogram (ECHO).
Atrial fibrillation, atrial flutter, or other uncontrolled arrhythmias that would prohibit accurate electromechanical mapping and NOGA-guided intramyocardial injection.
Bleeding diathesis with an INR > 1.8 when not receiving anti-thrombotic therapy.
Hepatic dysfunction as evidenced by elevated AST or ALT levels > 2.5 x ULN.
Any previous transplant requiring immunosuppression.
Disease state requiring chronic immunosuppression.

Name	Affiliation	Role
Caladrius Study Director	Caladrius Biosciences	Study Director

PubMed Identifier	Type	Citation	Retractions
27491607	Derived	Povsic TJ, Henry TD, Traverse JH, Fortuin FD, Schaer GL, Kereiakes DJ, Schatz RA, Zeiher AM, White CJ, Stewart DJ, Jolicoeur EM, Bass T, Henderson DA, Dignacco P, Gu Z, Al-Khalidi HR, Junge C, Nada A, Hunt AS, Losordo DW; RENEW Investigators. The RENEW Trial: Efficacy and Safety of Intramyocardial Autologous CD34(+) Cell Administration in Patients With Refractory Angina. JACC Cardiovasc Interv. 2016 Aug 8;9(15):1576-85. doi: 10.1016/j.jcin.2016.05.003.
23708155

ID	Title	Description
FG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
FG001	Active Control Arm

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol

Baseline (BL) is the average of the two total exercise times measured during the screening period.

Participants in the Intent to Treat population defined as participants randomized to Treatment or Active Control arms. For participants not receiving intramyocardial injections, the missing values were imputed i.e. replaced with substituted values from the baseline.

Posted

Mean

Standard Deviation

seconds

Baseline and 12 month visit

ID	Title	Description
OG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
OG001	Active Control Arm	Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis

Units	Counts
Participants	OG00057 OG00127

Title

Denominators

Categories

Title	Measurements
	OG000108.7± 194.3 OG00190.0± 184.7

Secondary

Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit

Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline (screening period) and in the 4 weeks before the 3, 6 and 12 month follow-up visits.

Posted

Mean

Standard Deviation

angina episodes per week

Baseline and 12 month visit

ID	Title	Description
OG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
OG001	Active Control Arm	Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis

Units	Counts
Participants

Secondary

Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit

Baseline (BL) is the average of the two total exercise times measured during the screening period.

Posted

Mean

Standard Deviation

seconds

Baseline and 6 month visit

ID	Title	Description
OG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
OG001	Active Control Arm	Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis

Units	Counts
Participants	OG000

Secondary

Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit

Posted

Mean

Standard Deviation

angina episodes per week

6 month visit

ID	Title	Description
OG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
OG001	Active Control Arm	Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period

Major adverse cardiac events (MACE) defined as death, cardiac hospitalization, non-fatal myocardial infarction and stroke, as adjudicated by an independent clinical endpoint classification (CEC) committee.

The category Total MACE includes death, cardiovascular hospitalization, myocardial infarction or stroke.

Participants in the safety population as Treated.

Posted

Number

95% Confidence Interval

percent

From randomization until the end of the 24 month follow-up period

ID	Title	Description
OG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
OG001	Active Control Arm	Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis.
OG002	Unblinded Standard of Care (SOC) Arm	No study-related procedures will be performed.
OG003	Not Injected Arm

Secondary

Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period

Safety Population as Treated.

Posted

Number

percent

From randomization until the end of the 24 month follow-up period

ID	Title	Description
OG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
OG001	Active Control Arm	Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
OG002	Unblinded Standard of Care (SOC) Arm	No study-related procedures will be performed.
OG003	Not Injected Arm	Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG0009 events7 affected50 at risk EG0013 events2 affected28 at risk EG00218 events11 affected28 at risk EG0030 events0 affected6 at risk
Angina unstable	Cardiac disorders	Non-systematic Assessment	EG0007 events4 affected50 at risk EG0012 events2 affected28 at risk EG0023 events3 affected28 at risk EG003
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0013 events3 affected28 at risk EG0021 events1 affected28 at risk EG003
Cardiac failure congestive	Cardiac disorders	Non-systematic Assessment	EG0004 events3 affected50 at risk EG0013 events2 affected28 at risk EG0022 events2 affected28 at risk EG003
Coronary artery disease	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0023 events3 affected28 at risk EG003
Myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Ventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0002 events2 affected50 at risk EG0012 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Cardiac failure	Cardiac disorders	Non-systematic Assessment	EG0003 events2 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Cardiac failure acute	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0021 events1 affected28 at risk EG003
Pericardial effusion	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Acute coronary syndrome	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Arrhythmia	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
atrioventricular block first degree	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Cardiac tamponade	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Cardiogenic shock	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Chronotropic incompetence	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Coronary artery perforation	Cardiac disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Left ventricular dysfunction	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Myocardial ischaemia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Chest pain	General disorders	Non-systematic Assessment	EG0002 events2 affected50 at risk EG0011 events1 affected28 at risk EG0022 events2 affected28 at risk EG003
Non-cardiac chest pain	General disorders	Non-systematic Assessment	EG0002 events1 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Sudden cardiac death	General disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0021 events1 affected28 at risk EG003
Asthenia	General disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Device electrical impedance issue	General disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Disease progression	General disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Electrocution	General disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Vascular complication associated with device	General disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0023 events3 affected28 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0002 events2 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Diabetic gastroparesis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Gastric ulcer	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Ileus	Gastrointestinal disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Oesophagitis ulcerative	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Hypotension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Intermittent claudication	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Peripheral vascular disorder	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Hypertensive crisis	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Peripheral artery aneurysm	Vascular disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0002 events2 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Pneumonia	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Appendicitis	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Cholecystitis infective	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Endocarditis bacterial	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Urinary Tract Infection	Infections and infestations	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Fall	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Injury	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Meniscus lesion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Obesity	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Syncope	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0022 events2 affected28 at risk EG003
Carotid sinus syndrome	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Epilepsy	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Transient ischaemic attack	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 events1 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Retinal infarction	Eye disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Non-alcoholic steatohepatitis	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0011 events1 affected28 at risk EG0020 events0 affected28 at risk EG003
Ejection fraction decreased	Investigations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Meningioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003
Mental status changes	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0021 events1 affected28 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0005 events5 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG0031 events1 affected6 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Angina pectoris	Cardiac disorders	Non-systematic Assessment	EG00026 events17 affected50 at risk EG00115 events11 affected28 at risk EG0024 events4 affected28 at risk EG003
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Cardiac failure	Cardiac disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Cardiac failure congestive	Cardiac disorders	Non-systematic Assessment	EG0005 events4 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Palpitations	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Ventricular extrasystoles	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Ventricular tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Cataract	Eye disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Conjunctivitis	Eye disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Macular degeneration	Eye disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Abdominal pain	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0008 events8 affected50 at risk EG0010 events0 affected28 at risk EG0023 events3 affected28 at risk EG003
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0014 events3 affected28 at risk EG0022 events2 affected28 at risk EG003
Diverticulum	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Gastric polyps	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Gastric ulcer	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0007 events7 affected50 at risk EG0016 events5 affected28 at risk EG0022 events2 affected28 at risk EG003
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Chest discomfort	General disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Chest pain	General disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Chills	General disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Fatigue	General disorders	Non-systematic Assessment	EG0009 events9 affected50 at risk EG0019 events8 affected28 at risk EG0023 events3 affected28 at risk EG003
Influenza like illness	General disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Malaise	General disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Oedema peripheral	General disorders	Non-systematic Assessment	EG0006 events5 affected50 at risk EG0014 events2 affected28 at risk EG0026 events6 affected28 at risk EG003
Pain	General disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Vessel puncture site haematoma	General disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Drug hypersensitivity	Immune system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Breast infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0006 events5 affected50 at risk EG0015 events4 affected28 at risk EG0027 events5 affected28 at risk EG003
Ear infection	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Herpes zoster	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Influenza	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0013 events3 affected28 at risk EG0023 events3 affected28 at risk EG003
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Oral herpes	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Sinusitis	Infections and infestations	Non-systematic Assessment	EG00010 events9 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Tooth infection	Infections and infestations	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG00014 events13 affected50 at risk EG00113 events8 affected28 at risk EG0023 events2 affected28 at risk EG003
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG00016 events5 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0022 events2 affected28 at risk EG003
Blood creatine phosphokinase MB increased	Investigations	Non-systematic Assessment	EG0004 events4 affected50 at risk EG0016 events6 affected28 at risk EG0020 events0 affected28 at risk EG003
Blood creatinine increased	Investigations	Non-systematic Assessment	EG0009 events5 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Blood glucose increased	Investigations	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Blood urea increased	Investigations	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
C-reactive protein increased	Investigations	Non-systematic Assessment	EG0005 events5 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Haematology test abnormal	Investigations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Neutrophil count increased	Investigations	Non-systematic Assessment	EG0005 events5 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Platelet count decreased	Investigations	Non-systematic Assessment	EG0004 events4 affected50 at risk EG0015 events5 affected28 at risk EG0020 events0 affected28 at risk EG003
Prostatic specific antigen increased	Investigations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Troponin increased	Investigations	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
White blood cell count increased	Investigations	Non-systematic Assessment	EG0004 events3 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00012 events9 affected50 at risk EG00116 events11 affected28 at risk EG0023 events3 affected28 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00012 events9 affected50 at risk EG00114 events12 affected28 at risk EG0027 events5 affected28 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0008 events6 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0017 events7 affected28 at risk EG0022 events2 affected28 at risk EG003
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0006 events5 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0004 events3 affected50 at risk EG0016 events6 affected28 at risk EG0020 events0 affected28 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0007 events7 affected50 at risk EG0016 events5 affected28 at risk EG0020 events0 affected28 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0004 events3 affected50 at risk EG0012 events2 affected28 at risk EG0022 events2 affected28 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0004 events3 affected50 at risk EG0010 events0 affected28 at risk EG0026 events5 affected28 at risk EG003
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0008 events7 affected50 at risk EG0017 events7 affected28 at risk EG0022 events2 affected28 at risk EG003
Headache	Nervous system disorders	Non-systematic Assessment	EG00010 events9 affected50 at risk EG0019 events5 affected28 at risk EG0020 events0 affected28 at risk EG003
Hypoaesthesia	Nervous system disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Memory impairment	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Paraesthesia	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Restless legs syndrome	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Syncope	Nervous system disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0016 events6 affected28 at risk EG0020 events0 affected28 at risk EG003
Depression	Psychiatric disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003
Insomnia	Psychiatric disorders	Non-systematic Assessment	EG0003 events3 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Haematuria	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Renal failure acute	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0014 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0027 events2 affected28 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0006 events4 affected50 at risk EG0010 events0 affected28 at risk EG0022 events2 affected28 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0008 events7 affected50 at risk EG0013 events3 affected28 at risk EG0022 events2 affected28 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 events3 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Dermal cyst	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0010 events0 affected28 at risk EG0020 events0 affected28 at risk EG003
Hypertension	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0022 events2 affected28 at risk EG003
Hypotension	Vascular disorders	Non-systematic Assessment	EG0006 events5 affected50 at risk EG0013 events3 affected28 at risk EG0020 events0 affected28 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected50 at risk EG0012 events2 affected28 at risk EG0020 events0 affected28 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D002637	Chest Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

ID	Title	Description
BG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
BG001	Active Control Arm	Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
BG002	Unblinded Standard of Care (SOC) Arm	No study-related procedures will be performed.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Arm	Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis	31	50	48	50
EG001	Active Control Arm	Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis	17	28	26	28
EG002	Unblinded Standard of Care (SOC) Arm	No study-related procedures will be performed.	22	28	23	28
EG003	Not Treated Arm	Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.	3	6	5	6