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OpenTrials
Completed

NCT Number: NCT01833585

Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with critical limb ischemia confirmed by toe pressure, ABI, TCOM
  • Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion
  • Poor distal artery runoff
  • Age 18-70 year

Exclusion criteria

  • Planned for major amputation within 4 weeks
  • Receive blood component within 4 weeks
  • Acute myocardial infarction
  • severe valvular heart disease
  • renal failure
  • liver failure
  • Cancer
  • Hypercoagulable state
  • Severe infection
  • Pregnancy

Treatment and study plan

Peripheral blood mononuclear cell

Biological

Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia

Primary outcomes

  1. Number of patients without major amputation after mononuclear cell injection

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Pilot Study of Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 17, 2013
Registry last updated
Aug 17, 2018

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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