Treatment of Non Atherosclerosis Limb Ischemia Patients by Cytokine-mobilized peripheral blood mononuclear cells

Phase 3

Recruiting

• Conditions: imb ischemia; Limb ischemia, stem cell, peripheral blood mononuclear cell

• Registration Number: TCTR20220407001
• Lead Sponsor: Faculty of Medicine, Siriraj Hospital, Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-07
• Study Completion: 2023-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients with no-option CLTI caused by non atherosclerosis diseases
Patients present with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months

Exclusion Criteria

Limb ischemia caused by atherosclerosis
Recent myocardial infarction
Severe valvular heart disease
After organ transplantation
Cardiomyopthy( EF< 25%)
Liver failure
Coagulopathy
HIV
Malignancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
imb saving 6 months Observation,Claudication distance 3 ,6 , 9 , 12 months Pedometer

Secondary Outcome Measures

Name	Time	Method
Transcutaneous oxygen measurement 3,6,9,12 months Transcutaneous oxygen measurement,Ankle brachial index 3,6,9,12 months Ankle brachial index,Toe pressure Brachial index 3,6,9,12 months Toe pressure Brachial index