Trial Outcomes & Findings for Patients With Intermittent Claudication Injected With ALDH Bright Cells (NCT NCT01774097)

NCT ID: NCT01774097

Last Updated: 2017-04-21

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 82 participants
• Primary outcome timeframe: Assessed at baseline and 6 months
• Results posted on: 2017-04-21

Participant Flow

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.

Participant milestones

Measure	ALDHbr Participants will receive ALDHbr via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh	Placebo (Vehicle) Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Overall Study STARTED	40	42
Overall Study COMPLETED	38	40
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	ALDHbr Participants will receive ALDHbr via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh	Placebo (Vehicle) Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	1	1

Baseline Characteristics

Patients With Intermittent Claudication Injected With ALDH Bright Cells

Baseline characteristics by cohort

Measure	ALDHbr n=38 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=40 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh	Total n=78 Participants Total of all reporting groups
Age, Continuous	66.3 Years STANDARD_DEVIATION 8.6 • n=5 Participants	66.2 Years STANDARD_DEVIATION 8.7 • n=7 Participants	66.2 Years STANDARD_DEVIATION 8.65 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	31 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	40 participants n=7 Participants	78 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at baseline and 6 months

Population: Participants who had available analyzable baseline and 6 month treadmill test results.

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.

Outcome measures

Measure	ALDHbr n=37 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=39 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Peak Walking Time (PWT)	2.2 minutes Standard Deviation 3.9	1.2 minutes Standard Deviation 2.7

PRIMARY outcome

Timeframe: Assessed at baseline and 6 months

Population: Participants who had available analyzable baseline and 6 month MRI imaging

The placebo adjusted average change in the number of collateral vessels over time.

Outcome measures

Measure	ALDHbr n=37 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=38 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Leg Collateral Count (Via Contrast Enhanced-MR)	1.5 vessel count Standard Deviation 2.7	0.6 vessel count Standard Deviation 2.2

PRIMARY outcome

Timeframe: Assessed at baseline and 6 months

Population: Participants who had available analyzable baseline and 6 month MRI imaging

The placebo adjusted average change in peak hyperemic popliteal flow (mL/s) over time.

Outcome measures

Measure	ALDHbr n=35 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=36 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Peak Hyperemic Popliteal Flow (Phase Contrast MRA)	0.2 ml/sec Standard Deviation 1.5	0.2 ml/sec Standard Deviation 1.9

PRIMARY outcome

Timeframe: Assessed at baseline and 6 months

Population: Participants with available analyzable MRI imaging at baseline and 6 months

The placebo adjusted average change in capillary perfusion over time.

Outcome measures

Measure	ALDHbr n=38 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=38 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Capillary Perfusion	-0.42 percent Standard Deviation 2.40	-0.25 percent Standard Deviation 2.36

SECONDARY outcome

Timeframe: Assessed as a trajectory (baseline, 3mos, and 6 mos)

Population: Participants with available analyzable ABI data at baseline, 3 months, and 6 months

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.

Outcome measures

Measure	ALDHbr n=36 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=39 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Pre-exercise Ankle-Brachial Index (ABI)	0.61 ratio Standard Deviation 0.17	0.64 ratio Standard Deviation 0.14

SECONDARY outcome

Timeframe: Assessed as a trajectory (baseline, 3mos, and 6 mos)

Population: Participants with available analyzable ABI at baseline, 3 months, and 6 months

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.

Outcome measures

Measure	ALDHbr n=36 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=39 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Post-exercise Ankle-Brachial Index (ABI)	0.30 ratio Standard Deviation 0.15	0.34 ratio Standard Deviation 0.19

SECONDARY outcome

Timeframe: Assessed as a trajectory (baseline, 3mos, and 6 mos)

Population: Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.

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.

Outcome measures

Measure	ALDHbr n=34 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=35 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Claudication Onset Time (COT)	2.8 minutes Standard Deviation 1.9	2.5 minutes Standard Deviation 1.7

SECONDARY outcome

Timeframe: Assessed at baseline and 3 months

Population: Participants who had available analyzable baseline, 3 month, and 6 month treadmill test results.

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.

Outcome measures

Measure	ALDHbr n=36 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=38 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Peak Walking Time (PWT)	7.1 minutes Standard Deviation 4.4	6.0 minutes Standard Deviation 4.0

SECONDARY outcome

Timeframe: Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)

Population: Participants who had available analyzable baseline, 1 month, 3 month, and 6 month PAQs.

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.

Outcome measures

Measure	ALDHbr n=38 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=40 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Peripheral Artery Questionnaire (PAQ)	63.9 scores on a scale Standard Deviation 21.5	55.2 scores on a scale Standard Deviation 20.0

SECONDARY outcome

Timeframe: Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)

Population: Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs.

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.

Outcome measures

Measure	ALDHbr n=37 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=34 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Walking Impairment Questionnaire (WIQ)-Walking Distance Score	35.6 scores on a scale Standard Deviation 30.1	23.0 scores on a scale Standard Deviation 18.8

SECONDARY outcome

Timeframe: Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)

Population: Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs

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.

Outcome measures

Measure	ALDHbr n=35 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=37 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Walking Impairment Questionnaire (WIQ)- Walking Speed Score	48.9 scores on a scale Standard Deviation 20.7	41.8 scores on a scale Standard Deviation 25.1

SECONDARY outcome

Timeframe: Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos)

Population: Participants who had available analyzable baseline, 1 month, 3 month, and 6 month WIQs

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.

Outcome measures

Measure	ALDHbr n=35 Participants Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=38 Participants Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Walking Impairment Questionnaire (WIQ)-Ability to Climb Stairs Score	46.3 scores on a scale Standard Deviation 29.9	43.8 scores on a scale Standard Deviation 32.0

Adverse Events

ALDHbr

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo (Vehicle)

Serious events: 8 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	ALDHbr n=40 participants at risk Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=42 participants at risk Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Blood and lymphatic system disorders Acute Anemia	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Cardiac disorders Coronary artery disease	2.5% 1/40 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	0.00% 0/42 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Cardiac disorders Anginal discomfort (symptomatic)	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Infections and infestations Escherichia urinary tract infection	2.5% 1/40 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	0.00% 0/42 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Injury, poisoning and procedural complications Compression of fractured vertebra	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Injury, poisoning and procedural complications Post procedural hematoma (left popliteal)	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Injury, poisoning and procedural complications Motor vehicle accident	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	2.5% 1/40 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	0.00% 0/42 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Surgical and medical procedures CABG	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Vascular disorders Ischemic limb pain	2.5% 1/40 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	0.00% 0/42 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Vascular disorders Peripheral arterial disease (worsening)	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	2.4% 1/42 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.

Other adverse events

Measure	ALDHbr n=40 participants at risk Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh	Placebo (Vehicle) n=42 participants at risk Participants will receive placebo (vehicle) via intramuscular injection Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh
Nervous system disorders Facial paralysis (Bell's palsy)	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	4.8% 2/42 • Number of events 2 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
General disorders Chest pain	0.00% 0/40 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	4.8% 2/42 • Number of events 2 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.
Injury, poisoning and procedural complications Post operative hip pain	2.5% 1/40 • Number of events 1 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.	4.8% 2/42 • Number of events 2 • Events reported are from randomization date to the 6 month endpoint data collection window (i.e 210 days post intervention) 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.

Additional Information

Lemuel Moye, MD, PhD

UT-Houston School of Public Health

Phone: 713-500-9518

Email: lemmoye@msn.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place