NCT01833585

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

4.7 years

First QC Date

April 9, 2013

Last Update Submit

August 15, 2018

Conditions

Critical Limb IschemiaAtherosclerosisIschemic UlcerGangrene

Keywords

critical limb ischemiaatherosclerosisischemic ulcerrest paingangrene

Outcome Measures

Primary Outcomes (1)

  • Number of patients without major amputation after mononuclear cell injection

    3 month

Study Arms (1)

peripheral blood mononuclear cells

EXPERIMENTAL

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

Biological: Peripheral blood mononuclear cell

Interventions

Peripheral blood mononuclear cellBIOLOGICAL

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

peripheral blood mononuclear cells

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Chronic Limb-Threatening IschemiaAtherosclerosisGangrene

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemiaNecrosis

Study Officials

  • Nuttawut Sermsathanasawadi, MD.,Ph.D.

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 17, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

TH(1)