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Trial record 23 of 70 for:    stem cell peripheral arterial disease AND cell therapy

Patients With Intermittent Claudication Injected With ALDH Bright Cells (PACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01774097
Recruitment Status : Completed
First Posted : January 23, 2013
Results First Posted : April 21, 2017
Last Update Posted : April 21, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Aldagen
Center for Cell and Gene Therapy, Baylor College of Medicine
Information provided by (Responsible Party):
Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Peripheral Artery Disease
Intermittent Claudication
Interventions Biological: ALD-301
Biological: Placebo (vehicle)
Enrollment 82
Recruitment Details Enrollment took place at seven Network centers and their associated satellite facilities between 6/13/2013 and 12/8/2015. The main centers are located in Texas, Florida (2 locations), Minnesota, Kentucky, Indiana, and California. Study brochures, patient informational DVDs, and clinicaltrials.gov were among the tools used for recruitment.
Pre-assignment Details  
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description

Participants will receive ALDHbr via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Period Title: Overall Study
Started 40 42
Completed 38 40
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             1             1
Arm/Group Title ALDHbr Placebo (Vehicle) Total
Hide Arm/Group Description

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Total of all reporting groups
Overall Number of Baseline Participants 38 40 78
Hide Baseline Analysis Population Description
Information for 4 participants is not available due to patient withdrawal from the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 40 participants 78 participants
66.3  (8.6) 66.2  (8.7) 66.2  (8.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
Female
12
  31.6%
9
  22.5%
21
  26.9%
Male
26
  68.4%
31
  77.5%
57
  73.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.6%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
   7.9%
6
  15.0%
9
  11.5%
White
34
  89.5%
34
  85.0%
68
  87.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 40 participants 78 participants
38 40 78
1.Primary Outcome
Title Peak Walking Time (PWT)
Hide Description The placebo adjusted average change over time in the maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.
Time Frame Assessed at baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline and 6 month treadmill test results.
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 37 39
Mean (Standard Deviation)
Unit of Measure: minutes
2.2  (3.9) 1.2  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.238
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-0.6 to 2.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Leg Collateral Count (Via Contrast Enhanced-MR)
Hide Description The placebo adjusted average change in the number of collateral vessels over time.
Time Frame Assessed at baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline and 6 month MRI imaging
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:
Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 37 38
Mean (Standard Deviation)
Unit of Measure: vessel count
1.5  (2.7) 0.6  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.116
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-0.2 to 2.1
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6
Estimation Comments [Not Specified]
3.Primary Outcome
Title Peak Hyperemic Popliteal Flow (Phase Contrast MRA)
Hide Description The placebo adjusted average change in peak hyperemic popliteal flow (mL/s) over time.
Time Frame Assessed at baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline and 6 month MRI imaging
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 35 36
Mean (Standard Deviation)
Unit of Measure: ml/sec
0.2  (1.5) 0.2  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.978
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.8 to 0.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.4
Estimation Comments [Not Specified]
4.Primary Outcome
Title Capillary Perfusion
Hide Description The placebo adjusted average change in capillary perfusion over time.
Time Frame Assessed at baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available analyzable MRI imaging at baseline and 6 months
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 38 38
Mean (Standard Deviation)
Unit of Measure: percent
-0.42  (2.40) -0.25  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.752
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-1.26 to 0.91
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.55
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Pre-exercise Ankle-Brachial Index (ABI)
Hide Description ABI is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Pre-exercise ABI is collected routinely with the patient supine immediately prior to a treadmill test. This measure represents the placebo adjusted average change over time in arm and pedal (ankle) blood pressure. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.
Time Frame Assessed as a trajectory (baseline, 3mos, and 6 mos)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available analyzable ABI data at baseline, 3 months, and 6 months
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 36 39
Mean (Standard Deviation)
Unit of Measure: ratio
0.61  (0.17) 0.64  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter interaction term
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.02 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.01
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Post-exercise Ankle-Brachial Index (ABI)
Hide Description ABI is the ratio of the blood pressure at the ankle to the blood pressure of the upper arm. Post-exercise ABI is collected routinely with the patient supine immediately following a treadmill test. This measure represents the placebo adjusted average change over time in arm and pedal (ankle) blood pressure. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.
Time Frame Assessed as a trajectory (baseline, 3mos, and 6 mos)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available analyzable ABI at baseline, 3 months, and 6 months
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 36 39
Mean (Standard Deviation)
Unit of Measure: ratio
0.30  (0.15) 0.34  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.256
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter interaction term
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.06 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.02
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Claudication Onset Time (COT)
Hide Description Claudication Onset Time (COT) is the walking time at which patients first experience leg pain during a treadmill test. The measure represents placebo adjusted average change over time (in minutes) in the time walked by a patient on a treadmill under standardized conditions before the onset of claudication symptoms, regardless of whether this is manifested or characterized as muscle pain, ache, cramp, numbness or fatigue. This does not include joint pain or other pain not associated with claudication. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.
Time Frame Assessed as a trajectory (baseline, 3mos, and 6 mos)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: minutes
2.8  (1.9) 2.5  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.241
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter interaction term
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.2 to 0.6
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.2
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Peak Walking Time (PWT)
Hide Description The average change in maximum time (in minutes) walked by a patient on a treadmill under standardized conditions. The patient continues the test until walking can no longer be tolerated because of claudication symptoms.
Time Frame Assessed at baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 36 38
Mean (Standard Deviation)
Unit of Measure: minutes
7.1  (4.4) 6.0  (4.0)
9.Secondary Outcome
Title Peripheral Artery Questionnaire (PAQ)
Hide Description The Peripheral Artery Questionnaire (PAQ) assesses subjective physical limitations, leg symptoms, social function, treatment satisfaction, and quality of life. It is administered as a self report. Higher scores are indicative of better outcome. The summary scores is compiled by taking the mean of five subscales generated from the original questions. Range: Minimum score is 11.1, maximum 85. The measure represents placebo adjusted average change in Peripheral Artery Questionnaire (PAQ) summary score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.
Time Frame Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline, 1 month, 3 month, and 6 month PAQs.
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: scores on a scale
63.9  (21.5) 55.2  (20.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.1
Confidence Interval (2-Sided) 95%
-0.6 to 4.8
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.4
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Walking Impairment Questionnaire (WIQ)-Walking Distance Score
Hide Description The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0.2, maximum 100. The measure represents the placebo adjusted average change in WIQ walking distance score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.
Time Frame Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs.
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 37 34
Mean (Standard Deviation)
Unit of Measure: scores on a scale
35.6  (30.1) 23.0  (18.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.626
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-2.6 to 4.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.7
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Walking Impairment Questionnaire (WIQ)- Walking Speed Score
Hide Description The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0, maximum 87. The measure represents the placebo adjusted average change in WIQ walking speed score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.
Time Frame Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 35 37
Mean (Standard Deviation)
Unit of Measure: scores on a scale
48.9  (20.7) 41.8  (25.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.591
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.9
Confidence Interval (2-Sided) 95%
-4.1 to 2.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.6
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Walking Impairment Questionnaire (WIQ)-Ability to Climb Stairs Score
Hide Description The Walking Impairment Questionnaire (WIQ) assesses the severity of the subjective walking impairment on distance, speed, and stair climbing scales. It is administered as a self report. Range: Minimum score is 0, maximum 100. The measure represents the placebo adjusted average change in WIQ ability to climb stairs score assessed over time. The reported value is the estimate from regression analysis of the slope of the placebo adjusted measure over the time course of the trial adjusted for baseline weight.
Time Frame Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description:

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

Overall Number of Participants Analyzed 35 38
Mean (Standard Deviation)
Unit of Measure: scores on a scale
46.3  (29.9) 43.8  (32.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALDHbr, Placebo (Vehicle)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.722
Comments Threshold 0.05; no adjustment for multiple comparisons per protocol.
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-3.3 to 4.7
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.0
Estimation Comments [Not Specified]
Time Frame Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention)
Adverse Event Reporting Description Events were assessed systematically at each study visit during the physical exam assessment. A standard workbook was used to collect event details. Sponsor safety team reviewed events and requested additional documentation as needed.
 
Arm/Group Title ALDHbr Placebo (Vehicle)
Hide Arm/Group Description

Participants will receive ALDHbr cells via intramuscular injection

ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh

Participants will receive placebo (vehicle) via intramuscular injection

Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh

All-Cause Mortality
ALDHbr Placebo (Vehicle)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
ALDHbr Placebo (Vehicle)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/40 (10.00%)      8/42 (19.05%)    
Blood and lymphatic system disorders     
Acute Anemia  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Cardiac disorders     
Coronary artery disease  1  1/40 (2.50%)  1 0/42 (0.00%)  0
Anginal discomfort (symptomatic)  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal disorders     
Duodenal ulcer  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal haemorrhage  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations     
Escherichia urinary tract infection  1  1/40 (2.50%)  1 0/42 (0.00%)  0
Injury, poisoning and procedural complications     
Compression of fractured vertebra  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Post procedural hematoma (left popliteal)  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Motor vehicle accident  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder cancer  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders     
COPD exacerbation  1  1/40 (2.50%)  1 0/42 (0.00%)  0
Surgical and medical procedures     
CABG  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Vascular disorders     
Ischemic limb pain  1  1/40 (2.50%)  1 0/42 (0.00%)  0
Peripheral arterial disease (worsening)  1  0/40 (0.00%)  0 1/42 (2.38%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALDHbr Placebo (Vehicle)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      6/42 (14.29%)    
General disorders     
Chest pain  1  0/40 (0.00%)  0 2/42 (4.76%)  2
Injury, poisoning and procedural complications     
Post operative hip pain  1  1/40 (2.50%)  1 2/42 (4.76%)  2
Nervous system disorders     
Facial paralysis (Bell's palsy)  1  0/40 (0.00%)  0 2/42 (4.76%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Small sample size. Only follow up to 6 months. Limitation in the cell dose.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lemuel Moye, MD, PhD
Organization: UT-Houston School of Public Health
Phone: 713-500-9518
EMail: lemmoye@msn.com
Publications:
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. Review.
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Responsible Party: Dr Lemuel A Moye III, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01774097     History of Changes
Other Study ID Numbers: HSC-SPH-12-0785
UM1HL087318-06 ( U.S. NIH Grant/Contract )
First Submitted: January 18, 2013
First Posted: January 23, 2013
Results First Submitted: January 3, 2017
Results First Posted: April 21, 2017
Last Update Posted: April 21, 2017