Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia (ACT34-CLI)

Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia

The purpose of this study is to evaluate the safety and efficacy of intramuscular injections of adult stem cells in patients with Critical Limb Ischemia (CLI).

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease; Peripheral Artery Disease; Critical Limb Ischemia
• Intervention / Treatment: Biological: CD34-positive cells; Biological: Saline and 5% autologous plasma

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Cardiology, PC
  • Florida
    • Gainsville, Florida, United States, 32605
      • Florida Research Network LLC
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine Division of Vascular Surgery
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland, Case Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah-Vascular Surgery Division
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Comprehensive Cardiovascular Care St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 21-80 years of age
• moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or 5)
• unsuitable for conventional revascularization

Exclusion Criteria:

• advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue loss or gangrene
• advance AV block or NYHA Class III or Class IV heart failure
• myocardial infarction within 3 months of treatment
• successful coronary or lower extremity revascularization within 3 months of study enrollment
• arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder with the exception of thromboangitis obliterans (Buerger's Disease)
• co-morbidity associated with life expectancy of less than 1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline	Biological: Saline and 5% autologous plasma
Active Comparator: Low Dose	Biological: CD34-positive cells
Active Comparator: High Dose	Biological: CD34-positive cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety of Intramuscular Injection of CD34-positive cells	6 months and 1 year
Change in Rest Pain	6 months
Ulcer Healing	6 months
Functional Improvement	6 months
Limb Salvage	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease Severity	6 months
Assessment of Co-morbidity	6 months

Collaborators and Investigators

• Sponsor: Losordo, Douglas, M.D.
• Collaborators: Baxter Healthcare Corporation

Publications and helpful links

General Publications

• Moazzami B, Mohammadpour Z, Zabala ZE, Farokhi E, Roohi A, Dolmatova E, Moazzami K. Local intramuscular transplantation of autologous bone marrow mononuclear cells for critical lower limb ischaemia. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD008347. doi: 10.1002/14651858.CD008347.pub4.
• Losordo DW, Kibbe MR, Mendelsohn F, Marston W, Driver VR, Sharafuddin M, Teodorescu V, Wiechmann BN, Thompson C, Kraiss L, Carman T, Dohad S, Huang P, Junge CE, Story K, Weistroffer T, Thorne TM, Millay M, Runyon JP, Schainfeld R; Autologous CD34+ Cell Therapy for Critical Limb Ischemia Investigators. A randomized, controlled pilot study of autologous CD34+ cell therapy for critical limb ischemia. Circ Cardiovasc Interv. 2012 Dec;5(6):821-30. doi: 10.1161/CIRCINTERVENTIONS.112.968321. Epub 2012 Nov 27.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: January 24, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): July 25, 2011
• Last Update Submitted That Met QC Criteria: July 21, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: PAD; Stem Cells; PVD; CLI
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: STU00009937/STU00001469; 11931-02 (Other Identifier: Sponsor protocol number)