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

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ClinicalTrials.gov Identifier: NCT01833585
Recruitment Status : Recruiting
First Posted : April 17, 2013
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Critical Limb Ischemia Atherosclerosis Ischemic Ulcer Gangrene Biological: Peripheral blood mononuclear cell Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of patients without major amputation after mononuclear cell injection [ Time Frame: 3 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01833585     History of Changes
Other Study ID Numbers: SIRIRAJR015533013
First Posted: April 17, 2013    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016

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

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