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Completed

NCT Number: NCT00616980

Injection of Autologous CD34-Positive Cells for 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).

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Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Critical Limb Ischemia Disease Attributes Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Disease Peripheral Vascular Diseases Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cardiology, PC, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CD34-positive cells

Biological

Saline and 5% autologous plasma

Biological

Primary outcomes

  1. Safety of Intramuscular Injection of CD34-positive cells

    Time frame: 6 months and 1 year

  2. Change in Rest Pain

    Time frame: 6 months

  3. Ulcer Healing

    Time frame: 6 months

  4. Functional Improvement

    Time frame: 6 months

  5. Limb Salvage

    Time frame: 6 months

Secondary outcomes

  1. Disease Severity

    Time frame: 6 months

  2. Assessment of Co-morbidity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Losordo, Douglas, M.D.

Indiv

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study 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

Acronym: ACT34-CLI

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 15, 2008
Registry last updated
Jul 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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