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ACT34-CMI -- Adult Autologous CD34+ Cells

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ClinicalTrials.gov Identifier: NCT00300053
Recruitment Status : Completed
First Posted : March 8, 2006
Results First Posted : January 8, 2021
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Myocardial Ischemia
Interventions Biological: CLBS14 (low-dose)
Biological: CLBS14 (high-dose)
Biological: placebo injection
Enrollment 321
Recruitment Details Enrollment was conducted at 26 clinical sites in the US.
Pre-assignment Details Of 321 enrolled subjects, 147 were screen failures. Of 174 subjects who started cell mobilization, 1 did not complete the mobilization due to possible left ventricular mural thrombosis. Of 173 subjects who completed mobilization, 168 were randomized to 1 of 3 treatment groups, of which 1 was discontinued prior to treatment due to coagulopathy.
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control
Hide Arm/Group Description Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight) Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight) Intramyocardial placebo injections
Period Title: Overall Study
Started 55 [1] 56 [1] 56 [1]
3-Month Evaluation 55 56 54
6-Month Evaluation 54 55 53
Completed 53 53 50
Not Completed 2 3 6
Reason Not Completed
Patient/Caregiver Preference             2             2             3
Death             0             0             3
Lost to Follow-up             0             1             0
[1]
started = randomized and treated/injected
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control Total
Hide Arm/Group Description Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight) Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight) Intramyocardial placebo injections Total of all reporting groups
Overall Number of Baseline Participants 55 56 56 167
Hide Baseline Analysis Population Description
The efficacy/Intent-to-Treat (ITT) population comprises 167 subjects who received an intramyocardial injection of auto-CD34+ cells or placebo.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 56 participants 56 participants 167 participants
61.3  (9.1) 59.8  (9.2) 61.8  (8.5) 61.0  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 56 participants 56 participants 167 participants
Female
9
  16.4%
7
  12.5%
6
  10.7%
22
  13.2%
Male
46
  83.6%
49
  87.5%
50
  89.3%
145
  86.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 56 participants 56 participants 167 participants
55 56 56 167
1.Primary Outcome
Title Number of Angina Episodes Per Week at 6 and 12 Months
Hide Description 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.
Time Frame 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control
Hide Arm/Group Description:
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
Intramyocardial placebo injections
Overall Number of Participants Analyzed 50 50 46
Mean (Standard Deviation)
Unit of Measure: angina episodes/week
6 months 6.8  (1.1) 8.3  (1.1) 10.9  (1.2)
12 months 6.3  (1.2) 7.2  (1.1) 11.0  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CLBS14: Low-Dose Group, Placebo Control
Comments Frequency of angina episodes per week 6 months after treatment.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CLBS14: Low-Dose Group, Placebo Control
Comments Frequency of angina episodes per week 12 months after treatment.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CLBS14: High-Dose Group, Placebo Control
Comments Frequency of angina episodes per week 6 months after treatment.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CLBS14: High-Dose Group, Placebo Control
Comments Frequency of angina episodes per week 12 months after treatment.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Exercise Treadmill Test According to Modified Bruce Protocol: Mean Change From Baseline in Duration of Exercise
Hide Description A modified Bruce Protocol Exercise Treadmill Test was used to evaluate duration of exercise in all subjects.
Time Frame Change from Baseline to 6 months and change from baseline to 12 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (note that the number of participants analyzed may differ due to missing data)
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control
Hide Arm/Group Description:
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
Intramyocardial placebo injections
Overall Number of Participants Analyzed 49 48 41
Mean (Standard Deviation)
Unit of Measure: seconds
Change from baseline to 6 months 139  (151) 110  (155) 69  (122)
Change from baseline to 12 months 140  (171) 103  (162) 58  (146)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CLBS14: Low-Dose Group, Placebo Control
Comments Change from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection CLBS14: Low-Dose Group, Placebo Control
Comments Change from baseline to 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CLBS14: High-Dose Group, Placebo Control
Comments Change from baseline to 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.097
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection CLBS14: High-Dose Group, Placebo Control
Comments Change from baseline to 12 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Number of Participants With Change in Canadian Cardiovascular Society Anginal Classification Levels
Hide Description

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
Time Frame Baseline and 12 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (note that the number of participants analyzed may differ due to missing data)
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control
Hide Arm/Group Description:
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
Intramyocardial placebo injections
Overall Number of Participants Analyzed 52 52 46
Measure Type: Count of Participants
Unit of Measure: Participants
No change in CCS classification from baseline
16
  30.8%
19
  36.5%
16
  34.8%
Improvement by 1 level (CCS) from baseline
22
  42.3%
17
  32.7%
19
  41.3%
Improvement by 2 levels (CCS) from baseline
11
  21.2%
12
  23.1%
5
  10.9%
Worsening by 1 level (CCS) from baseline
2
   3.8%
3
   5.8%
4
   8.7%
Worsening by 2 levels (CCS) from baseline
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Changes From Baseline in Seattle Angina Questionnaire (SAQ) Scores at 6 Months
Hide Description 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.
Time Frame Baseline to 6 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (note that the number of participants analyzed may differ due to missing data)
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control
Hide Arm/Group Description:
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
Intramyocardial placebo injections
Overall Number of Participants Analyzed 49 49 49
Mean (Standard Deviation)
Unit of Measure: score on a scale
Physical limitations scale 12.4  (15.6) 10.5  (17.1) 10.7  (15.2)
Angina stability scale 29.8  (30.1) 25.5  (30.3) 13.8  (31.9)
Angina frequency scale 28.3  (25.3) 21.7  (24.6) 26.0  (24.3)
Treatment satisfaction scale 11.4  (19.5) 10.3  (21.8) 4.9  (19.0)
Disease perception scale 14.4  (23.2) 12.0  (19.4) 15.1  (21.1)
5.Secondary Outcome
Title Changes From Baseline to 6 Months in Short Form 36 (SF-36) Parameters
Hide Description 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.
Time Frame Baseline to 6 months after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (note that the number of participants analyzed may differ due to missing data)
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control
Hide Arm/Group Description:
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
Intramyocardial placebo injections
Overall Number of Participants Analyzed 50 50 47
Mean (Standard Deviation)
Unit of Measure: score on a scale
Physical functioning 13.7  (18.1) 13.2  (18.4) 7.9  (21.8)
Role-physical 17.5  (35.1) 15.9  (33.6) 19.4  (33.2)
Bodily pain 13.5  (22.1) 13.5  (21.6) 9.4  (25.1)
General health 7.6  (15.5) 6.0  (15.3) 6.3  (15.4)
Vitality 14.6  (18.0) 14.0  (20.7) 8.9  (23.2)
Social functioning 16.8  (24.1) 12.2  (24.3) 12.0  (32.3)
Role emotional 10.7  (43.9) 17.9  (51.8) 9.7  (50.5)
Mental health 6.2  (16.0) 8.4  (17.9) 3.6  (13.6)
Health transition 40.4  (32.5) 32.7  (31.1) 29.6  (30.0)
6.Secondary Outcome
Title Change in Anti-anginal Medication (ie, Nitroglycerin) Use
Hide Description The mean nitroglycerin use per week was analyzed at baseline and 6 months
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (note that the number of participants analyzed may differ due to missing data)
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control
Hide Arm/Group Description:
Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight)
Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight)
Intramyocardial placebo injections
Overall Number of Participants Analyzed 46 50 50
Mean (Standard Deviation)
Unit of Measure: nitroglycerin use (tablets per week)
-6.3  (8.1) -7.3  (9.9) -4.2  (8.8)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population comprises 174 subjects who received at least 1 dose of G-CSF.
 
Arm/Group Title CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control No Cell or Placebo Injection
Hide Arm/Group Description Intramyocardial injections of auto-CD34+ cells at low dose (1 x 10^5 cells/kg bodyweight) Intramyocardial injections of auto-CD34+ cells at high dose (5 x 10^5 cells/kg bodyweight) Intramyocardial placebo injections Cell mobilization with G-CSF started but no cell or placebo injection administered
All-Cause Mortality
CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control No Cell or Placebo Injection
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)      0/56 (0.00%)      3/56 (5.36%)      0/7 (0.00%)    
Hide Serious Adverse Events
CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control No Cell or Placebo Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/55 (38.18%)      24/56 (42.86%)      32/56 (57.14%)      5/7 (71.43%)    
Blood and lymphatic system disorders         
Thrombocytopenia * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Coagulopathy  1  0/55 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/7 (14.29%)  1
Pancytopenia  1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Anemia * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  2 0/7 (0.00%)  0
Hypercoagulation * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 0/56 (0.00%)  0 1/7 (14.29%)  1
Cardiac disorders         
Cardiac perforation * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Cardiac failure congestive * 1  1/55 (1.82%)  3 1/56 (1.79%)  1 2/56 (3.57%)  4 0/7 (0.00%)  0
Myocardial infarction * 1  3/55 (5.45%)  5 2/56 (3.57%)  3 3/56 (5.36%)  4 3/7 (42.86%)  3
Angina pectoris * 1  8/55 (14.55%)  15 8/56 (14.29%)  12 11/56 (19.64%)  19 0/7 (0.00%)  0
Cardiac failure * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 2/56 (3.57%)  3 0/7 (0.00%)  0
Acute coronary syndrome * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 1/56 (1.79%)  1 0/7 (0.00%)  0
Ventricular tachycardia * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Ventricular fibrillation * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Angina unstable * 1  2/55 (3.64%)  2 2/56 (3.57%)  2 0/56 (0.00%)  0 0/7 (0.00%)  0
Atrial fibrillation * 1  2/55 (3.64%)  2 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Bradycardia * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Gastrointestinal disorders         
Nausea * 1  2/55 (3.64%)  2 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Vomiting * 1  2/55 (3.64%)  2 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Abdominal pain * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Abdominal discomfort * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Gastrointestinal ulcer hemorrhage  1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Colitis ischaemic * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Upper gastrointestinal hemorrhage * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Hematochezia * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Diverticular perforation * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
General disorders         
Chest pain * 1  0/55 (0.00%)  0 1/56 (1.79%)  4 2/56 (3.57%)  3 0/7 (0.00%)  0
Ischemic ulcer * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Non-cardiac chest pain * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  2 0/7 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Infections and infestations         
Esophageal candidiasis * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Pneumonia * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Septic phlebitis * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Urinary tract infection * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Sepsis * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Cellulitis * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 2/56 (3.57%)  2 0/7 (0.00%)  0
Osteomyelitis * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Gastroenteritis viral * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Injury, poisoning and procedural complications         
Vascular access complication * 1  1/55 (1.82%)  1 3/56 (5.36%)  3 2/56 (3.57%)  3 0/7 (0.00%)  0
Vascular graft occlusion  1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Concussion * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Road traffic accident * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Device lead damage * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  2 0/7 (0.00%)  0
Cardiac pacemaker malfunction * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Device dislocation * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Metabolism and nutrition disorders         
Hyperglycemia * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Dehydration * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Hypoglycemia * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Gout * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Tenosynovitis * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Musculoskeletal chest pain * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon cancer * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Nervous system disorders         
Cerebrovascular accident * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 1/56 (1.79%)  1 0/7 (0.00%)  0
Syncope * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Transient ischemic attack * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Presyncope * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Dizziness postural * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Dizziness * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Psychiatric disorders         
Depression * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Renal and urinary disorders         
Urinary tract obstruction * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Renal failure acute * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Reproductive system and breast disorders         
Menorrhagia * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Respiratory distress  1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Hypoxia  1  0/55 (0.00%)  0 1/56 (1.79%)  1 1/56 (1.79%)  1 0/7 (0.00%)  0
Dyspnea * 1  1/55 (1.82%)  1 1/56 (1.79%)  1 1/56 (1.79%)  1 0/7 (0.00%)  0
Dyspnea exertional * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Pneumonia aspiration * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Acute pulmonary edema * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Sleep apnea syndrome * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Sinus disorder  1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Pulmonary embolism * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
Pleural effusion * 1  0/55 (0.00%)  0 1/56 (1.79%)  1 0/56 (0.00%)  0 0/7 (0.00%)  0
Respiratory failure * 1  1/55 (1.82%)  2 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Vascular disorders         
Hypotension * 1  1/55 (1.82%)  1 2/56 (3.57%)  2 0/56 (0.00%)  0 0/7 (0.00%)  0
Deep vein thrombosis (DVT) * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Aortic aneurysm * 1  1/55 (1.82%)  1 0/56 (0.00%)  0 0/56 (0.00%)  0 0/7 (0.00%)  0
Peripheral arterial occlusive disease * 1  0/55 (0.00%)  0 0/56 (0.00%)  0 1/56 (1.79%)  1 0/7 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CLBS14: Low-Dose Group CLBS14: High-Dose Group Placebo Control No Cell or Placebo Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   54/55 (98.18%)      52/56 (92.86%)      52/56 (92.86%)      5/7 (71.43%)    
Cardiac disorders         
Angina Pectoris  1  20/55 (36.36%)  25 14/56 (25.00%)  18 12/56 (21.43%)  16 1/7 (14.29%)  1
Palpitations * 1  2/55 (3.64%)  2 4/56 (7.14%)  4 3/56 (5.36%)  3 0/7 (0.00%)  0
Gastrointestinal disorders         
Diarrhea * 1  6/55 (10.91%)  6 5/56 (8.93%)  6 5/56 (8.93%)  5 0/7 (0.00%)  0
Nausea * 1  13/55 (23.64%)  14 11/56 (19.64%)  16 9/56 (16.07%)  10 0/7 (0.00%)  0
Vomiting * 1  5/55 (9.09%)  5 4/56 (7.14%)  6 1/56 (1.79%)  1 0/7 (0.00%)  0
General disorders         
Chest Pain * 1  5/55 (9.09%)  5 3/56 (5.36%)  21 2/56 (3.57%)  3 1/7 (14.29%)  1
Fatigue * 1  15/55 (27.27%)  15 9/56 (16.07%)  9 11/56 (19.64%)  11 0/7 (0.00%)  0
Edema Peripheral * 1  3/55 (5.45%)  3 5/56 (8.93%)  5 6/56 (10.71%)  6 0/7 (0.00%)  0
Pain * 1  7/55 (12.73%)  8 9/56 (16.07%)  9 6/56 (10.71%)  6 2/7 (28.57%)  2
Infections and infestations         
Upper Respiratory Tract Infection * 1  7/55 (12.73%)  9 2/56 (3.57%)  2 4/56 (7.14%)  5 0/7 (0.00%)  0
Injury, poisoning and procedural complications         
Vascular Access Complication * 1  14/55 (25.45%)  22 14/56 (25.00%)  18 11/56 (19.64%)  22 1/7 (14.29%)  1
Metabolism and nutrition disorders         
Hypocalcemia * 1  8/55 (14.55%)  8 9/56 (16.07%)  9 4/56 (7.14%)  4 0/7 (0.00%)  0
Hypokalemia * 1  4/55 (7.27%)  4 4/56 (7.14%)  4 6/56 (10.71%)  8 2/7 (28.57%)  2
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  12/55 (21.82%)  15 12/56 (21.43%)  14 8/56 (14.29%)  9 0/7 (0.00%)  0
Back Pain * 1  17/55 (30.91%)  18 19/56 (33.93%)  25 11/56 (19.64%)  11 0/7 (0.00%)  0
Bone Pain * 1  13/55 (23.64%)  13 11/56 (19.64%)  14 10/56 (17.86%)  10 1/7 (14.29%)  1
Musculoskeletal Chest Pain * 1  4/55 (7.27%)  8 3/56 (5.36%)  4 5/56 (8.93%)  5 0/7 (0.00%)  0
Musculoskeletal Pain * 1  5/55 (9.09%)  7 4/56 (7.14%)  7 0/56 (0.00%)  0 0/7 (0.00%)  0
Myalgia * 1  3/55 (5.45%)  3 4/56 (7.14%)  4 4/56 (7.14%)  4 1/7 (14.29%)  1
Neck Pain * 1  2/55 (3.64%)  2 6/56 (10.71%)  6 2/56 (3.57%)  2 0/7 (0.00%)  0
Pain in Extremity * 1  7/55 (12.73%)  12 7/56 (12.50%)  8 6/56 (10.71%)  7 0/7 (0.00%)  0
Nervous system disorders         
Dizziness * 1  8/55 (14.55%)  8 5/56 (8.93%)  6 6/56 (10.71%)  6 0/7 (0.00%)  0
Headache * 1  16/55 (29.09%)  20 25/56 (44.64%)  31 10/56 (17.86%)  10 4/7 (57.14%)  4
Paresthesia * 1  12/55 (21.82%)  15 15/56 (26.79%)  15 17/56 (30.36%)  24 2/7 (28.57%)  2
Psychiatric disorders         
Anxiety * 1  3/55 (5.45%)  3 4/56 (7.14%)  4 2/56 (3.57%)  2 1/7 (14.29%)  1
Insomnia * 1  6/55 (10.91%)  6 7/56 (12.50%)  8 6/56 (10.71%)  6 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders         
Cough * 1  4/55 (7.27%)  4 5/56 (8.93%)  5 2/56 (3.57%)  2 0/7 (0.00%)  0
Dyspnea * 1  5/55 (9.09%)  5 7/56 (12.50%)  8 14/56 (25.00%)  16 1/7 (14.29%)  1
Vascular disorders         
Hypertension * 1  3/55 (5.45%)  3 3/56 (5.36%)  3 4/56 (7.14%)  5 1/7 (14.29%)  1
Hypotension * 1  3/55 (5.45%)  3 6/56 (10.71%)  7 4/56 (7.14%)  5 1/7 (14.29%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
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.
For this study, PIs are restricted from independently publishing results before completion of a single multicenter publication or one year after study completion, whichever occurs first. Baxter requires a review of the intended publication at least 60 days prior to submission. Baxter may request an additional delay of 45 days to secure patent and/or other proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: William Sietsema
Organization: Caladrius Biosciences
Phone: 9495352391
EMail: bsietsema@caladrius.com
Layout table for additonal information
Responsible Party: Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00300053    
Other Study ID Numbers: 24779
First Submitted: March 6, 2006
First Posted: March 8, 2006
Results First Submitted: December 18, 2015
Results First Posted: January 8, 2021
Last Update Posted: January 26, 2021