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NCT01833585 Clinical Trial

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

Atherosclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01833585
Other study ID # SIRIRAJR015533013
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2013
Est. completion date December 2017

Study information
Verified date August 2018
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Thailand Vascular Surgery, Siriraj Hospital, Mahidol University Bangkoknoi Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients without major amputation after mononuclear cell injection 3 month
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