Treatment of No-option CLI by G-CSF-mobilized PB-MNC

Critical Limb Ischemia Clinical Trial

Official title:

Treatment of No-option CLI Patients by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03686228
• Other study ID #: SI016033012/2
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2021
• Source: Mahidol University
• Contact: Nuttawut SERMSATHANASAWADI
• Phone: +66851118278
• Email: nuttawut[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Amputation free survival,Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months.

Description:

This study will investigate the efficacy of G-CSF mobilized mononuclear cell injection of patients with PAD who presented with no-option CLI. Forty no-option CLI patients who presented with rest pain, non-healing ischemic ulcer or gangrene will be randomized into 2 groups. The control group will be treated by medication and supportive treatment. The experiment group will be injected G-CSF mobilized mononuclear cell ,medication. Ankle brachial index(ABI), Toe brachial index (TBI) and transcutaneous oxygen measurement will be evaluated at the day of randomization, 1 , 3, 6 and 12 months in the control group and day of randomization, 1 , 3, 6 and 12 months after injection of PB-MNC in the experiment group. Amputation free survival will be evaluated at , 1 , 3, 6 and 12 months after PB-MNC therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months

Exclusion Criteria:

• Recent myocardial infarction

• Severe valvular heart disease

• After organ transplantation

• Cardiomyopthy( EF< 25%)

• Liver failure

• Coagulopathy

• HIV

Related Conditions & MeSH terms

• Atherosclerotic Ischemic Disease
• Critical Limb Ischemia
• Ischemia
• PAD

Intervention

Procedure:
• PB-MNC therapy
The patients will receive subcutaneous injection of Granulocyte colony stimulating factor (G-CSF) for 3 day. The mononuclear cell will be collected by blood cell separator. The 120 cc of cell solution will be injected into calf or thigh of ischemic limb (1cc per site) with needle no. 25 gauge. Patients will receive ASA 81 mg once daily and wound care and pain killer drug

Drug:
• No-PB-MNC therapy
Patients will receive ASA 81 mg once daily and wound care and pain killer drug

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	Amputation free survival	Rate of non amputated limb	3 month
Secondary	Amputation free survival	Rate of non amputated limb	1,6,12 month
Secondary	Ankle brachial index (ABI)	Ankle brachial indexThe Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. It has been shown to be a specific and sensitive metric for the diagnosis of Peripheral Arterial Disease (PAD)	1,3,6,12 month
Secondary	Toe brachial index (TBI)	Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures	1,3,6,12 month
Secondary	Transcutaneous oxygen measurement (TCOM)	Transcutaneous oxygen measurement	1,3,6,12 month
Secondary	36-Item Short Form Health Survey (SF36)	SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.	1,3,6,12 month