ACT34-CMI -- Adult Autologous CD34+ Cells | NCT00300053

Label	Type	Description	Intervention Names
CLBS14: Low-Dose Group	Experimental	10 intramyocardial injections of 0.2 mL each of auto-CD34+ cells at a dose of 1 x 10^5 (=100000) cells/kg bodyweight	Biological: CLBS14 (low-dose)
CLBS14: High-Dose Group	Experimental	10 intramyocardial injections of 0.2 mL each of auto-CD34+ cells at a dose of 5 x 10^5 (=500000) cells/kg bodyweight	Biological: CLBS14 (high-dose)
Placebo injection	Placebo Comparator	10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma	Biological: placebo injection

Name	Type	Description	Arm Group Labels	Other Names
CLBS14 (low-dose)	Biological	Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 1 x 10^5 (=100000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.

Measure	Description	Time Frame
Number of Angina Episodes Per Week at 6 and 12 Months	The number of angina episodes were collected via an electronic subject diary for four weeks at Baseline and at 6 and 12 months. The four-week angina episodes (per week mean) were used as the frequency for each visit. A lower number represents fewer angina episodes. A lower number is better.	6 and 12 months

Measure	Description	Time Frame
Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise	A modified Bruce Protocol Exercise Treadmill Test was used to evaluate duration of exercise in all subjects.	Change from Baseline to 6 months and change from baseline to 12 months after treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Canadian Cardiovascular Society (CCS) functional class III or IV chronic refractory angina
subjects without control of their angina symptoms, in spite of maximal tolerated doses of anti-anginal drugs, must be on optimal therapy for their angina and on a stable anti-anginal medication regimen for at least 1 month prior to entering the screening period of the study
identified as unsuitable for conventional revascularization
recent coronary angiogram (within the last 12 months) to document the coronary anatomy and to verify the revascularization procedures
subjects must have objective evidence of inducible ischemia or viable myocardium in the potential target injection zone
a left ventricular ejection fraction equal to or greater than 25% by ECHO or single photon emission computed tomography (SPECT) at screening
subjects must experience at minimum an average of 7 angina or anginal equivalent episodes per week
subjects must be able to complete a minimum of 3 minutes but nor more than 10 minutes on a treadmill following the Modified Bruce Protocol
subjects must experience angina or anginal equivalent episodes during the screening exercise treadmill test
female subjects must either be no longer capable of reproduction or using medically valid contraception to prevent pregnancy during the study
subjects must be willing and able to comply with specified follow-up evaluations

Exclusion Criteria:

predominant congestive heart failure
myocardial infarction within 60 days of treatment
successful or partially successful coronary revascularization procedures (any vessel) within 6 months of study enrollment
placement of a bi-ventricular pacemaker for cardiac resynchronization therapy (CRT) for heart failure in the past 90 days
documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment
history of moderate to severe aortic stenosis or severe aortic insufficiency; severe mitral stenosis or severe mitral insufficiency
prosthetic aortic valve replacement
evidence of any life-threatening arrhythmia that requires intervention on the 24-hour Holter monitor. Life-threatening arrhythmia that is successfully treated with an implantable cardioverter defibrillator (ICD) is not exclusionary.
splenomegaly and/or severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (ie, severe chronic obstructive pulmonary disease, renal failure or cancer [exceptions: in-situ skin cancer or fully removed skin cancer other than melanoma, in-situ cervical cancer, or cancer free for 5 years with no history of a stem cell transplant])
sickle cell disease or sickle cell trait
platelet count greater than 10% above the upper limit of normal or a platelet count below 100,000 if on Clopidogrel or 50,000 without Clopidogrel
hematocrit <30%
serum creatinine >2.5 mg/dL
any clinically significant laboratory abnormality on screening laboratories
currently enrolled in another IDE or IND that has not completed the protocol required primary follow-up period (excludes 15 year follow up of gene therapy trials)
history of alcohol or drug abuse within 3 months of screening
joint or peripheral vascular disease or neurologic disease that severely limits treadmill walking
chronic obstructive pulmonary disease that severely limits walking or FEV1 <30% predicted
females who are pregnant or lactating
female subjects who are capable of reproduction and will not use medically valid contraception to prevent pregnancy during the study
subjects who test positive for HIV, hepatitis B or hepatitis C, or are on chronic immunosuppressive medications or have had a prior stem cell transplant
subjects with a known hypersensitivity to E. coli-derived proteins, or to any component of Neupogen (Filgrastim) or G-CSF
subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject´s ability to provide informed consent and/or comply with protocol procedures

Name	Affiliation	Role
Caladrius Study DIrector	Lisata Therapeutics, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology PC		Birmingham	Alabama	35211	United States
Arizona Heart Institute

PubMed Identifier	Type	Citation	Retractions
21737787	Result	Losordo DW, Henry TD, Davidson C, Sup Lee J, Costa MA, Bass T, Mendelsohn F, Fortuin FD, Pepine CJ, Traverse JH, Amrani D, Ewenstein BM, Riedel N, Story K, Barker K, Povsic TJ, Harrington RA, Schatz RA; ACT34-CMI Investigators. Intramyocardial, autologous CD34+ cell therapy for refractory angina. Circ Res. 2011 Aug 5;109(4):428-36. doi: 10.1161/CIRCRESAHA.111.245993. Epub 2011 Jul 7.
27151378

ID	Title	Description
FG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
FG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)

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

Number of Angina Episodes Per Week at 6 and 12 Months

The number of angina episodes were collected via an electronic subject diary for four weeks at Baseline and at 6 and 12 months. The four-week angina episodes (per week mean) were used as the frequency for each visit. A lower number represents fewer angina episodes. A lower number is better.

Intent-to-treat (ITT) population

Posted

Mean

Standard Deviation

angina episodes/week

6 and 12 months

ID	Title	Description
OG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
OG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
OG002	Placebo Control	Intramyocardial placebo injections

Units	Counts
Participants	OG00050 OG00150 OG00246

Title

Denominators

Categories

6 months

Title	Measurements
	OG0006.8± 1.1 OG0018.3± 1.1 OG00210.9± 1.2

12 months

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Frequency of angina episodes per week 6 months after treatment.	ANCOVA		0.020														Superiority
OG000 OG002	Frequency of angina episodes per week 12 months after treatment.	ANCOVA

Secondary

Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise

A modified Bruce Protocol Exercise Treadmill Test was used to evaluate duration of exercise in all subjects.

ITT population (note that the number of participants analyzed may differ due to missing data)

Posted

Mean

Standard Deviation

seconds

Change from Baseline to 6 months and change from baseline to 12 months after treatment

ID	Title	Description
OG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
OG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
OG002	Placebo Control	Intramyocardial placebo injections

Units	Counts
Participants

Secondary

Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels

The Canadian Cardiovascular Society (CCS) Functional Classification of Angina is as follows:

Class I - Angina only during strenuous or prolonged physical activity
Class II - Slight limitation, with angina only during vigorous physical activity
Class III - Symptoms with everyday living activities, i.e., moderate limitation
Class IV - Inability to perform any activity without angina or angina at rest, i.e., severe limitation

ITT population (note that the number of participants analyzed may differ due to missing data)

Posted

Count of Participants

Participants

Baseline and 12 months after treatment

ID	Title	Description
OG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
OG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
OG002	Placebo Control	Intramyocardial placebo injections

Secondary

Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months

Angina symptoms were evaluated based on the Seattle Angina Questionnaire (SAQ), which was used to analyze the following: physical limitations, angina stability, angina frequency, treatment satisfaction, and disease perception. The SAQ consisted of 11 questions with 5 or 6 possible responses. Responses were ordinal values (1-7, 10, 11, 97, depending on the type of question; no uniform ranges throughout); responses that corresponded to the lowest level of functioning (worse outcomes) were assigned values of 1, while responses that corresponded to higher functioning levels (better outcome) were assigned a higher ordinal value. If the response to any of these questions was 97 it was recoded as a missing value. Each scale can have a scored value ranging from 0 to 100. A larger number is better.

ITT population (note that the number of participants analyzed may differ due to missing data)

Posted

Mean

Standard Deviation

score on a scale

Baseline to 6 months after treatment

ID	Title	Description
OG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
OG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
OG002

Secondary

Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters

The Short Form 36 (SF-36) health survey form was used to analyze physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, general mental health, and health transition. Responses were coded as ordinal numbers going from worst (=1) to best (=highest number). These ordinal scores were transformed into scales ranging from 0 to 100. Higher numbers are generally considered better.

ITT population (note that the number of participants analyzed may differ due to missing data)

Posted

Mean

Standard Deviation

score on a scale

Baseline to 6 months after treatment

ID	Title	Description
OG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
OG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
OG002	Placebo Control	Intramyocardial placebo injections

Secondary

Change in Anti-anginal Medication (ie, Nitroglycerin) Use

The mean nitroglycerin use per week was analyzed at baseline and 6 months

ITT population (note that the number of participants analyzed may differ due to missing data)

Posted

Mean

Standard Deviation

nitroglycerin use (tablets per week)

Baseline to 6 months

ID	Title	Description
OG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
OG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
OG002	Placebo Control	Intramyocardial placebo injections

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac perforation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG0030 events0 affected7 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events1 affected55 at risk EG0011 events1 affected56 at risk EG0024 events2 affected56 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0021 events1 affected56 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events3 affected55 at risk EG0013 events2 affected56 at risk EG0024 events3 affected56 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00015 events8 affected55 at risk EG00112 events8 affected56 at risk EG00219 events11 affected56 at risk EG003
Vascular access complication	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0013 events3 affected56 at risk EG0023 events2 affected56 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0023 events2 affected56 at risk EG003
Hypotension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0012 events2 affected56 at risk EG0020 events0 affected56 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0021 events1 affected56 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0011 events1 affected56 at risk EG0021 events1 affected56 at risk EG003
Dyspnea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Gastrointestinal ulcer hemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Chest pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0014 events1 affected56 at risk EG0023 events2 affected56 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0021 events1 affected56 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Acute pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Sleep apnea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Depression	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Sinus disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Deep vein thrombosis (DVT)	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected55 at risk EG0012 events2 affected56 at risk EG0020 events0 affected56 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Syncope	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Esophageal candidiasis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Pneumonia	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Anemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0022 events1 affected56 at risk EG003
Device lead damage	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0022 events1 affected56 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Septic phlebitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Hypercoagulation	Blood and lymphatic system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Transient ischemic attack	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Sepsis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Cellulitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0022 events2 affected56 at risk EG003
Ischemic ulcer	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Presyncope	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Dizziness postural	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Hypoglycemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Cardiac pacemaker malfunction	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Device dislocation	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Hematochezia	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0011 events1 affected56 at risk EG0020 events0 affected56 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0022 events1 affected56 at risk EG003
Dizziness	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Diverticular perforation	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0000 events0 affected55 at risk EG0010 events0 affected56 at risk EG0021 events1 affected56 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0001 events1 affected55 at risk EG0010 events0 affected56 at risk EG0020 events0 affected56 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG00025 events20 affected55 at risk EG00118 events14 affected56 at risk EG00216 events12 affected56 at risk EG0031 events1 affected7 at risk
Palpitations	Cardiac disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected55 at risk EG0014 events4 affected56 at risk EG0023 events3 affected56 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected55 at risk EG0016 events5 affected56 at risk EG0025 events5 affected56 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00014 events13 affected55 at risk EG00116 events11 affected56 at risk EG00210 events9 affected56 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected55 at risk EG0016 events4 affected56 at risk EG0021 events1 affected56 at risk EG003
Chest Pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected55 at risk EG00121 events3 affected56 at risk EG0023 events2 affected56 at risk EG003
Fatigue	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00015 events15 affected55 at risk EG0019 events9 affected56 at risk EG00211 events11 affected56 at risk EG003
Edema Peripheral	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected55 at risk EG0015 events5 affected56 at risk EG0026 events6 affected56 at risk EG003
Pain	General disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events7 affected55 at risk EG0019 events9 affected56 at risk EG0026 events6 affected56 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG0009 events7 affected55 at risk EG0012 events2 affected56 at risk EG0025 events4 affected56 at risk EG003
Vascular Access Complication	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Non-systematic Assessment	EG00022 events14 affected55 at risk EG00118 events14 affected56 at risk EG00222 events11 affected56 at risk EG003
Hypocalcemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events8 affected55 at risk EG0019 events9 affected56 at risk EG0024 events4 affected56 at risk EG003
Hypokalemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected55 at risk EG0014 events4 affected56 at risk EG0028 events6 affected56 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00015 events12 affected55 at risk EG00114 events12 affected56 at risk EG0029 events8 affected56 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00018 events17 affected55 at risk EG00125 events19 affected56 at risk EG00211 events11 affected56 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00013 events13 affected55 at risk EG00114 events11 affected56 at risk EG00210 events10 affected56 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events4 affected55 at risk EG0014 events3 affected56 at risk EG0025 events5 affected56 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0007 events5 affected55 at risk EG0017 events4 affected56 at risk EG0020 events0 affected56 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected55 at risk EG0014 events4 affected56 at risk EG0024 events4 affected56 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0002 events2 affected55 at risk EG0016 events6 affected56 at risk EG0022 events2 affected56 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00012 events7 affected55 at risk EG0018 events7 affected56 at risk EG0027 events6 affected56 at risk EG003
Dizziness	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0008 events8 affected55 at risk EG0016 events5 affected56 at risk EG0026 events6 affected56 at risk EG003
Headache	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00020 events16 affected55 at risk EG00131 events25 affected56 at risk EG00210 events10 affected56 at risk EG003
Paresthesia	Nervous system disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00015 events12 affected55 at risk EG00115 events15 affected56 at risk EG00224 events17 affected56 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected55 at risk EG0014 events4 affected56 at risk EG0022 events2 affected56 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0006 events6 affected55 at risk EG0018 events7 affected56 at risk EG0026 events6 affected56 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0004 events4 affected55 at risk EG0015 events5 affected56 at risk EG0022 events2 affected56 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0005 events5 affected55 at risk EG0018 events7 affected56 at risk EG00216 events14 affected56 at risk EG003
Hypertension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected55 at risk EG0013 events3 affected56 at risk EG0025 events4 affected56 at risk EG003
Hypotension	Vascular disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG0003 events3 affected55 at risk EG0017 events6 affected56 at risk EG0025 events4 affected56 at risk EG003

ID	Term
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
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Title	Description
BG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
BG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
BG002	Placebo Control	Intramyocardial placebo injections
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CLBS14: Low-Dose Group	Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)	0	55	21	55	54	55
EG001	CLBS14: High-Dose Group	Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)	0	56	24	56	52	56
EG002	Placebo Control	Intramyocardial placebo injections	3	56	32	56	52	56
EG003	No Cell or Placebo Injection	Cell mobilization with G-CSF started but no cell or placebo injection administered	0	7	5	7	5	7