Clinical trial NCT00616980: Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia
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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Critical Limb Ischemia
Keywords: PAD
PVD
CLI
Stem Cells
Lead sponsor: Losordo, Douglas, M.D.
Sponsor class: INDIV
Collaborators: name: Baxter Healthcare Corporation
First posted: 2008-02-15
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Safety of Intramuscular Injection of CD34-positive cells
timeFrame: 6 months and 1 year
measure: Change in Rest Pain
timeFrame: 6 months
measure: Ulcer Healing
timeFrame: 6 months
measure: Functional Improvement
timeFrame: 6 months
measure: Limb Salvage
timeFrame: 6 months
Secondary outcomes:
measure: Disease Severity
timeFrame: 6 months
measure: Assessment of Co-morbidity
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, PC
state: Alabama
city: Gainsville
country: United States
facility: Florida Research Network LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Mount Sinai School of Medicine Division of Vascular Surgery
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland, Case Medical Center
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah-Vascular Surgery Division
state: Utah
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Comprehensive Cardiovascular Care St. Luke's Medical Center
state: Wisconsin
Study officials:
References:
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.
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.