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

Losordo, Douglas, M.D.

Status and phase: Completed; Phase 2; Phase 1

Conditions: Peripheral Vascular Disease; Peripheral Artery Disease; Critical Limb Ischemia

Treatments: Biological: CD34-positive cells; Biological: Saline and 5% autologous plasma

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616980

11931-02 (Other Identifier)

STU00009937/STU00001469

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 3 patient groups, including a placebo group

Low Dose

Active Comparator group

Treatment:

Biological: CD34-positive cells

Biological: CD34-positive cells

High Dose

Active Comparator group

Treatment:

Biological: CD34-positive cells

Biological: CD34-positive cells

Saline

Placebo Comparator group

Treatment:

Biological: Saline and 5% autologous plasma