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Trial record 1 of 1 for:    NCT01508910
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Efficacy and Safety of Targeted Intramyocardial Delivery of Auto CD34+ Stem Cells for Improving Exercise Capacity in Subjects With Refractory Angina (RENEW)

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ClinicalTrials.gov Identifier: NCT01508910
Recruitment Status : Completed
First Posted : January 12, 2012
Results First Posted : February 15, 2017
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Chronic Myocardial Ischemia
Refractory Angina Pectoris
Advanced Coronary Heart Disease
Interventions Biological: Auto-CD34+ cells
Biological: Placebo: Diluent used to suspend Auto-CD34+ cells
Other: Standard of care
Enrollment 291
Recruitment Details The study started in May 2012 and completed in November 2015.
Pre-assignment Details 291 participants provided informed consent and were screened. There were 179 screen failures. 112 participants were randomized and treated. Note that during treatment the number of arms increased from 3 to 4 to include "Not Injected" arm as 6 participants in Treatment and Active Control Arms did not have intramyocardial injections.
Arm/Group Title Treatment Arm Active Control Arm Unblinded Standard of Care (SOC) Arm Not Injected Arm
Hide Arm/Group Description Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. No study-related procedures were performed. 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.
Period Title: Randomization
Started 57 27 28 0 [1]
Completed 57 27 28 0
Not Completed 0 0 0 0
[1]
Participants not randomized into Not Injected arm, but some were re-assigned here during treatment.
Period Title: Treatment
Started 50 28 28 6 [1]
Completed 48 24 18 3
Not Completed 2 4 10 3
Reason Not Completed
Death             2             3             2             0
Lost to Follow-up             0             0             2             1
Withdrawal by Subject             0             1             6             1
Sponsor Decision             0             0             0             1
[1]
3 moved from Treatment (Tx) to Active Control (AC) Arm; 6 in Not injected Arm(4 from Tx ; 2 from AC)
Arm/Group Title Treatment Arm Active Control Arm Unblinded Standard of Care (SOC) Arm Total
Hide Arm/Group Description Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis. No study-related procedures will be performed. Total of all reporting groups
Overall Number of Baseline Participants 57 27 28 112
Hide Baseline Analysis Population Description
Arms for baseline characteristics based on the Safety population as randomized i.e. randomized participants prior to treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants 27 participants 28 participants 112 participants
64  (8) 64  (8) 63  (10) 64  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 27 participants 28 participants 112 participants
Female
10
  17.5%
4
  14.8%
4
  14.3%
18
  16.1%
Male
47
  82.5%
23
  85.2%
24
  85.7%
94
  83.9%
1.Primary Outcome
Title Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) Using the Modified Bruce Protocol
Hide Description Baseline (BL) is the average of the two total exercise times measured during the screening period.
Time Frame Baseline and 12 month visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Arm Active Control Arm
Hide Arm/Group Description:
Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
Overall Number of Participants Analyzed 57 27
Mean (Standard Deviation)
Unit of Measure: seconds
108.7  (194.3) 90.0  (184.7)
2.Secondary Outcome
Title Angina Frequency (Episodes Per Week) at the 12 Month Follow-up Visit
Hide Description 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.
Time Frame Baseline and 12 month visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Arm Active Control Arm
Hide Arm/Group Description:
Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
Overall Number of Participants Analyzed 57 27
Mean (Standard Deviation)
Unit of Measure: angina episodes per week
Number of weekly angina episodes at baseline 20.1  (13.0) 16.5  (9.4)
Number of weekly angina episodes at Month 12 visit 7.7  (9.5) 5.4  (7.4)
3.Secondary Outcome
Title Change From Baseline in Total Exercise Time on Exercise Tolerance Test (ETT) at the 6 Month Follow-up Visit
Hide Description Baseline (BL) is the average of the two total exercise times measured during the screening period.
Time Frame Baseline and 6 month visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Arm Active Control Arm
Hide Arm/Group Description:
Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
Overall Number of Participants Analyzed 57 27
Mean (Standard Deviation)
Unit of Measure: seconds
126.5  (161.1) 93.5  (138.6)
4.Secondary Outcome
Title Angina Frequency (Episodes Per Week) at the 6 Month Follow-up Visit
Hide Description [Not Specified]
Time Frame 6 month visit
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Treatment Arm Active Control Arm
Hide Arm/Group Description:
Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
Overall Number of Participants Analyzed 57 27
Mean (Standard Deviation)
Unit of Measure: angina episodes per week
8.0  (9.6) 8.4  (9.8)
5.Secondary Outcome
Title Percentage of Participants With Incidences of MACE From Randomization Until the End of the 24 Month Follow-up Period
Hide Description

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.

Time Frame From randomization until the end of the 24 month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the safety population as Treated.
Arm/Group Title Treatment Arm Active Control Arm Unblinded Standard of Care (SOC) Arm Not Injected Arm
Hide Arm/Group Description:
Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis.
No study-related procedures will be performed.
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.
Overall Number of Participants Analyzed 50 28 28 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
Cardiovascular Hospitalization
42.0
(28.2 to 56.8)
32.1
(15.9 to 52.4)
64.3
(44.1 to 81.4)
33.3
(4.3 to 77.7)
Death
4.0
(0.5 to 13.7)
10.7
(2.3 to 28.2)
7.1
(0.9 to 23.5)
0
(0 to 0)
Myocardial Infarction
10.0
(3.3 to 21.8)
10.7
(2.3 to 28.2)
7.1
(0.9 to 23.5)
33.3
(4.3 to 77.7)
Stroke
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Total MACE (see outcome measure description)
46.0
(31.8 to 60.7)
42.9
(24.5 to 62.8)
67.9
(47.6 to 84.1)
33.3
(4.3 to 77.7)
Myocardial Perforation
4.0
(0.5 to 13.7)
0
(0 to 0)
0
(0 to 0)
16.7
(0.4 to 64.1)
Ventricular Arrhythmia
2.0
(0.1 to 10.6)
7.1
(0.9 to 23.5)
3.6
(0.1 to 18.3)
0
(0 to 0)
6.Secondary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event (SAE) From Randomization Until the End of the 24 Month Follow-up Period
Hide Description [Not Specified]
Time Frame From randomization until the end of the 24 month follow-up period
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population as Treated.
Arm/Group Title Treatment Arm Active Control Arm Unblinded Standard of Care (SOC) Arm Not Injected Arm
Hide Arm/Group Description:
Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
No study-related procedures will be performed.
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.
Overall Number of Participants Analyzed 50 28 28 6
Measure Type: Number
Unit of Measure: percent
62.0 60.7 78.6 50.0
Time Frame From randomization until the end of the 24 month follow-up period
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment Arm Active Control Arm Unblinded Standard of Care (SOC) Arm Not Treated Arm
Hide Arm/Group Description Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis No study-related procedures will be performed. 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.
All-Cause Mortality
Treatment Arm Active Control Arm Unblinded Standard of Care (SOC) Arm Not Treated Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Treatment Arm Active Control Arm Unblinded Standard of Care (SOC) Arm Not Treated Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/50 (62.00%)      17/28 (60.71%)      22/28 (78.57%)      3/6 (50.00%)    
Blood and lymphatic system disorders         
Anaemia *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Cardiac disorders         
Angina pectoris *  7/50 (14.00%)  9 2/28 (7.14%)  3 11/28 (39.29%)  18 0/6 (0.00%)  0
Angina unstable *  4/50 (8.00%)  7 2/28 (7.14%)  2 3/28 (10.71%)  3 1/6 (16.67%)  1
Acute myocardial infarction *  3/50 (6.00%)  3 3/28 (10.71%)  3 1/28 (3.57%)  1 1/6 (16.67%)  2
Cardiac failure congestive *  3/50 (6.00%)  4 2/28 (7.14%)  3 2/28 (7.14%)  2 0/6 (0.00%)  0
Coronary artery disease *  0/50 (0.00%)  0 1/28 (3.57%)  1 3/28 (10.71%)  3 0/6 (0.00%)  0
Myocardial infarction *  2/50 (4.00%)  2 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Ventricular tachycardia *  2/50 (4.00%)  2 1/28 (3.57%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Cardiac failure *  2/50 (4.00%)  3 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Cardiac failure acute *  0/50 (0.00%)  0 1/28 (3.57%)  1 1/28 (3.57%)  1 0/6 (0.00%)  0
Pericardial effusion *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Acute coronary syndrome *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Arrhythmia *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Atrial fibrillation *  0/50 (0.00%)  0 1/28 (3.57%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
atrioventricular block first degree *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Cardiac tamponade *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Cardiogenic shock *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Chronotropic incompetence *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Coronary artery perforation *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Ischaemic cardiomyopathy *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Left ventricular dysfunction *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Myocardial ischaemia *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Eye disorders         
Retinal infarction *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Gastrointestinal disorders         
Small intestinal obstruction *  2/50 (4.00%)  2 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Abdominal pain *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Diabetic gastroparesis *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Diverticulum intestinal haemorrhagic *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Gastric ulcer *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Gastrooesophageal reflux disease *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Ileus *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Oesophagitis ulcerative *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Pancreatitis acute *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
General disorders         
Chest pain *  2/50 (4.00%)  2 1/28 (3.57%)  1 2/28 (7.14%)  2 0/6 (0.00%)  0
Non-cardiac chest pain *  1/50 (2.00%)  2 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Sudden cardiac death *  0/50 (0.00%)  0 1/28 (3.57%)  1 1/28 (3.57%)  1 0/6 (0.00%)  0
Asthenia *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Device electrical impedance issue *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Disease progression *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Electrocution *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Vascular complication associated with device *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders         
Non-alcoholic steatohepatitis *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Infections and infestations         
Cellulitis *  2/50 (4.00%)  2 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Pneumonia *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Appendicitis *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Cholecystitis infective *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Endocarditis bacterial *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Urinary Tract Infection *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications         
Fall *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Humerus fracture *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Injury *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Meniscus lesion *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Spinal compression fracture *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Subdural haematoma *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Investigations         
Ejection fraction decreased *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Metabolism and nutrition disorders         
Hypokalaemia *  1/50 (2.00%)  1 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Dehydration *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Diabetes mellitus inadequate control *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Diabetic ketoacidosis *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Obesity *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthritis *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Arthropathy *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Back pain *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Lumbar spinal stenosis *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal chest pain *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Osteoarthritis *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Rhabdomyolysis *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Rotator cuff syndrome *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Spinal column stenosis *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Spinal osteoarthritis *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Brain neoplasm benign *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Meningioma malignant *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Nervous system disorders         
Syncope *  0/50 (0.00%)  0 2/28 (7.14%)  2 2/28 (7.14%)  2 0/6 (0.00%)  0
Carotid sinus syndrome *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Epilepsy *  0/50 (0.00%)  0 1/28 (3.57%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Transient ischaemic attack *  0/50 (0.00%)  0 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Psychiatric disorders         
Mental status changes *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease *  0/50 (0.00%)  0 1/28 (3.57%)  1 3/28 (10.71%)  3 0/6 (0.00%)  0
Dyspnoea *  1/50 (2.00%)  1 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Dyspnoea exertional *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 0/6 (0.00%)  0
Epistaxis *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Haemoptysis *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Pleural effusion *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders         
Hypotension *  0/50 (0.00%)  0 0/28 (0.00%)  0 1/28 (3.57%)  1 1/6 (16.67%)  1
Intermittent claudication *  1/50 (2.00%)  1 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Peripheral vascular disorder *  1/50 (2.00%)  1 1/28 (3.57%)  1 0/28 (0.00%)  0 0/6 (0.00%)  0
Hypertensive crisis *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Peripheral artery aneurysm *  1/50 (2.00%)  1 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment Arm Active Control Arm Unblinded Standard of Care (SOC) Arm Not Treated Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/50 (96.00%)      26/28 (92.86%)      23/28 (82.14%)      5/6 (83.33%)    
Blood and lymphatic system disorders         
Anaemia *  5/50 (10.00%)  5 3/28 (10.71%)  3 0/28 (0.00%)  0 1/6 (16.67%)  1
Thrombocytopenia *  3/50 (6.00%)  3 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Cardiac disorders         
Angina pectoris *  17/50 (34.00%)  26 11/28 (39.29%)  15 4/28 (14.29%)  4 2/6 (33.33%)  4
Atrial fibrillation *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Cardiac failure *  3/50 (6.00%)  3 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Cardiac failure congestive *  4/50 (8.00%)  5 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Myocardial ischaemia   0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Palpitations *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 1/6 (16.67%)  1
Ventricular extrasystoles *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
Ventricular tachycardia *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 1/6 (16.67%)  1
Eye disorders         
Cataract *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
Conjunctivitis *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Macular degeneration *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders         
Abdominal pain *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
Abdominal pain lower *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 1/6 (16.67%)  1
Constipation *  8/50 (16.00%)  8 0/28 (0.00%)  0 3/28 (10.71%)  3 0/6 (0.00%)  0
Diarrhoea *  3/50 (6.00%)  3 3/28 (10.71%)  4 2/28 (7.14%)  2 2/6 (33.33%)  3
Diverticulum *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Gastric polyps *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Gastric ulcer *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Gastrooesophageal reflux disease *  0/50 (0.00%)  0 2/28 (7.14%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
Nausea *  7/50 (14.00%)  7 5/28 (17.86%)  6 2/28 (7.14%)  2 1/6 (16.67%)  1
Vomiting *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
General disorders         
Chest discomfort *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Chest pain *  0/50 (0.00%)  0 2/28 (7.14%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
Chills *  3/50 (6.00%)  3 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Fatigue *  9/50 (18.00%)  9 8/28 (28.57%)  9 3/28 (10.71%)  3 2/6 (33.33%)  2
Influenza like illness *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Malaise *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Oedema peripheral *  5/50 (10.00%)  6 2/28 (7.14%)  4 6/28 (21.43%)  6 0/6 (0.00%)  0
Pain *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 1/6 (16.67%)  1
Vessel puncture site haematoma *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 1/6 (16.67%)  1
Immune system disorders         
Drug hypersensitivity *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations         
Breast infection *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Bronchitis *  5/50 (10.00%)  6 4/28 (14.29%)  5 5/28 (17.86%)  7 0/6 (0.00%)  0
Ear infection *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Herpes zoster *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Influenza *  3/50 (6.00%)  3 3/28 (10.71%)  3 3/28 (10.71%)  3 0/6 (0.00%)  0
Nasopharyngitis *  3/50 (6.00%)  3 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Oral herpes *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Sinusitis *  9/50 (18.00%)  10 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Tooth infection *  3/50 (6.00%)  3 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Upper respiratory tract infection *  13/50 (26.00%)  14 8/28 (28.57%)  13 2/28 (7.14%)  3 0/6 (0.00%)  0
Urinary tract infection *  5/50 (10.00%)  16 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications         
Contusion *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Procedural pain *  0/50 (0.00%)  0 2/28 (7.14%)  2 2/28 (7.14%)  2 0/6 (0.00%)  0
Investigations         
Blood creatine phosphokinase MB increased *  4/50 (8.00%)  4 6/28 (21.43%)  6 0/28 (0.00%)  0 0/6 (0.00%)  0
Blood creatinine increased *  5/50 (10.00%)  9 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Blood glucose increased *  3/50 (6.00%)  3 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Blood urea increased *  3/50 (6.00%)  3 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
C-reactive protein increased *  5/50 (10.00%)  5 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Haematology test abnormal *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Neutrophil count increased *  5/50 (10.00%)  5 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Platelet count decreased *  4/50 (8.00%)  4 5/28 (17.86%)  5 0/28 (0.00%)  0 0/6 (0.00%)  0
Prostatic specific antigen increased *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Troponin increased *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
White blood cell count increased *  3/50 (6.00%)  4 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders         
Hypocalcaemia *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Hypokalaemia *  3/50 (6.00%)  3 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Vitamin D deficiency *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia *  9/50 (18.00%)  12 11/28 (39.29%)  16 3/28 (10.71%)  3 0/6 (0.00%)  0
Back pain *  9/50 (18.00%)  12 12/28 (42.86%)  14 5/28 (17.86%)  7 1/6 (16.67%)  2
Bone pain *  6/50 (12.00%)  8 2/28 (7.14%)  2 0/28 (0.00%)  0 1/6 (16.67%)  1
Bursitis *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Muscle spasms *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Muscular weakness *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Musculoskeletal chest pain *  3/50 (6.00%)  3 7/28 (25.00%)  7 2/28 (7.14%)  2 0/6 (0.00%)  0
Musculoskeletal discomfort *  5/50 (10.00%)  6 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal pain *  3/50 (6.00%)  4 6/28 (21.43%)  6 0/28 (0.00%)  0 0/6 (0.00%)  0
Myalgia *  7/50 (14.00%)  7 5/28 (17.86%)  6 0/28 (0.00%)  0 1/6 (16.67%)  1
Neck pain *  3/50 (6.00%)  4 2/28 (7.14%)  2 2/28 (7.14%)  2 1/6 (16.67%)  1
Pain in extremity *  3/50 (6.00%)  4 0/28 (0.00%)  0 5/28 (17.86%)  6 1/6 (16.67%)  1
Nervous system disorders         
Dizziness *  7/50 (14.00%)  8 7/28 (25.00%)  7 2/28 (7.14%)  2 2/6 (33.33%)  2
Headache *  9/50 (18.00%)  10 5/28 (17.86%)  9 0/28 (0.00%)  0 1/6 (16.67%)  1
Hypoaesthesia *  3/50 (6.00%)  3 2/28 (7.14%)  2 0/28 (0.00%)  0 2/6 (33.33%)  2
Memory impairment *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
Paraesthesia *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 2/6 (33.33%)  2
Restless legs syndrome *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Syncope *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  2
Psychiatric disorders         
Anxiety *  3/50 (6.00%)  3 6/28 (21.43%)  6 0/28 (0.00%)  0 0/6 (0.00%)  0
Depression *  3/50 (6.00%)  3 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Insomnia *  3/50 (6.00%)  3 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Renal and urinary disorders         
Haematuria *  0/50 (0.00%)  0 3/28 (10.71%)  3 0/28 (0.00%)  0 0/6 (0.00%)  0
Renal failure acute *  0/50 (0.00%)  0 3/28 (10.71%)  4 0/28 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease *  0/50 (0.00%)  0 0/28 (0.00%)  0 2/28 (7.14%)  7 0/6 (0.00%)  0
Cough *  4/50 (8.00%)  6 0/28 (0.00%)  0 2/28 (7.14%)  2 0/6 (0.00%)  0
Dyspnoea *  7/50 (14.00%)  8 3/28 (10.71%)  3 2/28 (7.14%)  2 1/6 (16.67%)  1
Epistaxis *  3/50 (6.00%)  4 0/28 (0.00%)  0 0/28 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermal cyst *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Nail discolouration *  0/50 (0.00%)  0 0/28 (0.00%)  0 0/28 (0.00%)  0 1/6 (16.67%)  1
Vascular disorders         
Hypertension *  0/50 (0.00%)  0 2/28 (7.14%)  2 2/28 (7.14%)  2 0/6 (0.00%)  0
Hypotension *  5/50 (10.00%)  6 3/28 (10.71%)  3 0/28 (0.00%)  0 1/6 (16.67%)  1
Peripheral arterial occlusive disease *  0/50 (0.00%)  0 2/28 (7.14%)  2 0/28 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Study terminated early due to business considerations. Participants in Treatment or Active Control arms who did not have injection of target cells/placebo assigned to Not Injected Arm. Not included in efficacy analysis but in safety follow-up.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Baxalta's agreements with PIs may vary per requirements of individual PI, but contain common elements. For this study, results may not be published without prior written approval of Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Registries and Results Disclosure
Organization: Baxalta US Inc.
EMail: ClinicalTrialsDisclosure@baxalta.com
Layout table for additonal information
Responsible Party: Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01508910    
Other Study ID Numbers: 901001
RENEW Study ( Other Identifier: Caladrius Biosciences, Inc. )
First Submitted: January 10, 2012
First Posted: January 12, 2012
Results First Submitted: December 22, 2016
Results First Posted: February 15, 2017
Last Update Posted: December 19, 2018