Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00616980

Acronym

ACT34-CLI

Enrollment

Registered

2008-02-15

Start date

2007-12-31

Completion date

2010-08-31

Last updated

2011-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease

Keywords

PAD, PVD, CLI, Stem Cells

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).

Interventions

BIOLOGICALCD34-positive cells

BIOLOGICALSaline and 5% autologous plasma

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Assessment of Co-morbidity	6 months
Disease Severity	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026