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

Primary Purpose

Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CD34-positive cells
CD34-positive cells
Saline and 5% autologous plasma
Sponsored by
Losordo, Douglas, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring PAD, PVD, CLI, Stem Cells

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiology, PC
  • Florida Research Network LLC
  • Orlando Regional Medical Center
  • Northwestern University
  • University of Iowa Hospitals and Clinics
  • Massachusetts General Hospital
  • Mount Sinai School of Medicine Division of Vascular Surgery
  • University of North Carolina at Chapel Hill
  • University Hospitals of Cleveland, Case Medical Center
  • University of Utah-Vascular Surgery Division
  • Swedish Medical Center
  • Comprehensive Cardiovascular Care St. Luke's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Low Dose

High Dose

Saline

Arm Description

Outcomes

Primary Outcome Measures

Safety of Intramuscular Injection of CD34-positive cells
Change in Rest Pain
Ulcer Healing
Functional Improvement
Limb Salvage

Secondary Outcome Measures

Disease Severity
Assessment of Co-morbidity

Full Information

First Posted
January 24, 2008
Last Updated
July 21, 2011
Sponsor
Losordo, Douglas, M.D.
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00616980
Brief Title
Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
Acronym
ACT34-CLI
Official Title
Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Losordo, Douglas, M.D.
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia
Keywords
PAD, PVD, CLI, Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose
Arm Type
Active Comparator
Arm Title
High Dose
Arm Type
Active Comparator
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
CD34-positive cells
Intervention Type
Biological
Intervention Name(s)
CD34-positive cells
Intervention Type
Biological
Intervention Name(s)
Saline and 5% autologous plasma
Primary Outcome Measure Information:
Title
Safety of Intramuscular Injection of CD34-positive cells
Time Frame
6 months and 1 year
Title
Change in Rest Pain
Time Frame
6 months
Title
Ulcer Healing
Time Frame
6 months
Title
Functional Improvement
Time Frame
6 months
Title
Limb Salvage
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Disease Severity
Time Frame
6 months
Title
Assessment of Co-morbidity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cardiology, PC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Florida Research Network LLC
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Orlando Regional Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Mount Sinai School of Medicine Division of Vascular Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
University Hospitals of Cleveland, Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Utah-Vascular Surgery Division
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Comprehensive Cardiovascular Care St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35802393
Citation
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.
Results Reference
derived
PubMed Identifier
23192920
Citation
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.
Results Reference
derived

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Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia

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