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

• Sponsor: Mahidol University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03686228
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 63
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PAD; Critical Limb Ischemia; Atherosclerotic Ischemic Disease	Procedure: PB-MNC therapy; Drug: No-PB-MNC therapy	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of No-option CLI Patients by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
• Actual Study Start Date: Oct 1, 2018
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PB-MNC therapy 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; 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
Active Comparator: No PB-MNC therapy 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; Patients will receive ASA 81 mg once daily and wound care and pain killer drug

Outcome Measures

Primary Outcome Measures

1. Amputation free survival [3 month]

   Rate of non amputated limb

Secondary Outcome Measures

1. Amputation free survival [1,6,12 month]

   Rate of non amputated limb

2. Ankle brachial index (ABI) [1,3,6,12 month]

   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)

3. Toe brachial index (TBI) [1,3,6,12 month]

   Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures

4. Transcutaneous oxygen measurement (TCOM) [1,3,6,12 month]

   Transcutaneous oxygen measurement

5. 36-Item Short Form Health Survey (SF36) [1,3,6,12 month]

   SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vascular Surgery, Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

• Principal Investigator: Nuttawut SERMSATHANASAWADI, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT03686228
• Other Study ID Numbers: SI016033012/2
• First Posted: Sep 26, 2018
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Dec 17, 2021