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 April 2013 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01833585
First received: April 9, 2013
Last updated: April 14, 2013
Last verified: April 2013
  Purpose

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
Atherosclerosis
Ischemic Ulcer
Gangrene
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 2014
Estimated Primary Completion Date: December 2014 (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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01833585

Contacts
Contact: Nuttawut Sermsathanasawadi, MD.,Ph.D nuttawut@gmail.com

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

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01833585     History of Changes
Other Study ID Numbers: SIRIRAJR015533013
Study First Received: April 9, 2013
Last Updated: April 14, 2013
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Gangrene
Ischemia
Ulcer
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Necrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014