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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2015 by Mahidol University
Information provided by (Responsible Party):
Mahidol University Identifier:
First received: April 9, 2013
Last updated: September 28, 2015
Last verified: September 2015
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.

Condition Intervention Phase
Critical Limb Ischemia
Ischemic Ulcer
Biological: Peripheral blood mononuclear cell
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Resource links provided by NLM:

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Number of patients without major amputation after mononuclear cell injection [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peripheral blood mononuclear cells
peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia
Biological: Peripheral blood mononuclear cell
Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01833585

Contact: Nuttawut Sermsathanasawadi, MD.,Ph.D

Vascular Surgery, Siriraj Hospital, Mahidol University Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Nuttawut Sermsathanasawadi, MD., Ph.D   
Principal Investigator: Nuttawut Sermsathanasawadi, MD., Ph.D         
Sponsors and Collaborators
Mahidol University
Principal Investigator: Nuttawut Sermsathanasawadi, MD.,Ph.D. Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University Identifier: NCT01833585     History of Changes
Other Study ID Numbers: SIRIRAJR015533013
Study First Received: April 9, 2013
Last Updated: September 28, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
critical limb ischemia
ischemic ulcer
rest pain

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases processed this record on November 25, 2015