This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01774097
First received: January 18, 2013
Last updated: March 10, 2017
Last verified: March 2017
Results First Received: January 3, 2017  
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)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    ALDHbr   Placebo (Vehicle)
STARTED   40   42 
COMPLETED   38   40 
NOT COMPLETED   2   2 
Withdrawal by Subject                1                1 
Adverse Event                1                1 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Information for 4 participants is not available due to patient withdrawal from the study.

Reporting Groups
  Description
ALDHbr

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)

Participants will receive placebo (vehicle) via intramuscular injection

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

Total Total of all reporting groups

Baseline Measures
   ALDHbr   Placebo (Vehicle)   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   40   78 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.3  (8.6)   66.2  (8.7)   66.2  (8.65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  31.6%      9  22.5%      21  26.9% 
Male      26  68.4%      31  77.5%      57  73.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   38   40   78 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Peak Walking Time (PWT)   [ Time Frame: Assessed at baseline and 6 months ]

2.  Primary:   Leg Collateral Count (Via Contrast Enhanced-MR)   [ Time Frame: Assessed at baseline and 6 months ]

3.  Primary:   Peak Hyperemic Popliteal Flow (Phase Contrast MRA)   [ Time Frame: Assessed at baseline and 6 months ]

4.  Primary:   Capillary Perfusion   [ Time Frame: Assessed at baseline and 6 months ]

5.  Secondary:   Pre-exercise Ankle-Brachial Index (ABI)   [ Time Frame: Assessed as a trajectory (baseline, 3mos, and 6 mos) ]

6.  Secondary:   Post-exercise Ankle-Brachial Index (ABI)   [ Time Frame: Assessed as a trajectory (baseline, 3mos, and 6 mos) ]

7.  Secondary:   Claudication Onset Time (COT)   [ Time Frame: Assessed as a trajectory (baseline, 3mos, and 6 mos) ]

8.  Secondary:   Peak Walking Time (PWT)   [ Time Frame: Assessed at baseline and 3 months ]

9.  Secondary:   Peripheral Artery Questionnaire (PAQ)   [ Time Frame: Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos) ]

10.  Secondary:   Walking Impairment Questionnaire (WIQ)-Walking Distance Score   [ Time Frame: Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos) ]

11.  Secondary:   Walking Impairment Questionnaire (WIQ)- Walking Speed Score   [ Time Frame: Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos) ]

12.  Secondary:   Walking Impairment Questionnaire (WIQ)-Ability to Climb Stairs Score   [ Time Frame: Assessed as a trajectory (baseline, 1mos, 3mos, and 6 mos) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size. Only follow up to 6 months. Limitation in the cell dose.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lemuel Moye, MD, PhD
Organization: UT-Houston School of Public Health
phone: 713-500-9518
e-mail: 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.


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 )
Study First Received: January 18, 2013
Results First Received: January 3, 2017
Last Updated: March 10, 2017