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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833585

Enrollment

Registered

2013-04-17

Start date

2013-04-30

Completion date

2017-12-31

Last updated

2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Critical Limb Ischemia, Gangrene, Ischemic Ulcer

Keywords

critical limb ischemia, atherosclerosis, ischemic ulcer, rest pain, gangrene

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.

Interventions

BIOLOGICALPeripheral 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Number of patients without major amputation after mononuclear cell injection	3 month

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026