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

Primary Purpose

Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Peripheral blood mononuclear cell
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring critical limb ischemia, atherosclerosis, ischemic ulcer, rest pain, gangrene

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vascular Surgery, Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

peripheral blood mononuclear cells

Arm Description

peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia

Outcomes

Primary Outcome Measures

Number of patients without major amputation after mononuclear cell injection

Secondary Outcome Measures

Full Information

First Posted
April 9, 2013
Last Updated
August 15, 2018
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01833585
Brief Title
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
Official Title
Pilot Study of Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer, Gangrene
Keywords
critical limb ischemia, atherosclerosis, ischemic ulcer, rest pain, gangrene

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
peripheral blood mononuclear cells
Arm Type
Experimental
Arm Description
peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia
Intervention Type
Biological
Intervention Name(s)
Peripheral blood mononuclear cell
Intervention Description
Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia
Primary Outcome Measure Information:
Title
Number of patients without major amputation after mononuclear cell injection
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuttawut Sermsathanasawadi, MD.,Ph.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vascular Surgery, Siriraj Hospital, Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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