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

NCT03686228 | Unknown

• 1 other identifier: SI016033012/2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PAD; Critical Limb Ischemia; Atherosclerotic Ischemic Disease

Outcome Measures

Primary Outcomes (1)

• Amputation free survival

  Rate of non amputated limb

  3 month

Secondary Outcomes (5)

• Amputation free survival

  1,6,12 month

• Ankle brachial index (ABI)

  1,3,6,12 month

• Toe brachial index (TBI)

  1,3,6,12 month

• Transcutaneous oxygen measurement (TCOM)

  1,3,6,12 month

• 36-Item Short Form Health Survey (SF36)

  1,3,6,12 month

Study Arms (2)

PB-MNC therapy

ACTIVE COMPARATOR

The patientsin PB-MNC therapy group will be injected with G-CSF mobilized PB-MNC into calf or thigh muscle of ischemic limb and Aspirin 81 mg/day and supportive treatment including wound care and pain killer drug.

Procedure: PB-MNC therapy

No PB-MNC therapy

ACTIVE COMPARATOR

In patients in No PB-MNC therapy, they will receive aspirin 81 mg/day and supportive treatment including wound care and pain killer drug.

Drug: No-PB-MNC therapy

Interventions

PB-MNC therapy PROCEDURE

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

PB-MNC therapy

No-PB-MNC therapy DRUG

Patients will receive ASA 81 mg once daily and wound care and pain killer drug

No PB-MNC therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Recent myocardial infarction
• Severe valvular heart disease
• After organ transplantation
• Cardiomyopthy( EF\< 25%)
• Liver failure
• Coagulopathy
• HIV

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Vascular Surgery, Siriraj Hospital, Mahidol University

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Nuttawut SERMSATHANASAWADI

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuttawut SERMSATHANASAWADI

CONTACT

+66851118278; nuttawut@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 26, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)