PADNCT03686228
Treatment of No-option CLI by G-CSF-mobilized PB-MNC
A study testing PB-MNC therapy and No-PB-MNC therapy in people with PAD and Critical Limb Ischemia, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PAD, Critical Limb Ischemia, Atherosclerotic Ischemic Disease
- What is being tested?
- PB-MNC therapy and No-PB-MNC therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months
Who cannot join
- Recent myocardial infarction
- Severe valvular heart disease
- After organ transplantation
- Cardiomyopthy( EF< 25%)
- Liver failure
- Coagulopathy
- HIV
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
Nuttawut Sermsathanasawadi, MD., Ph.D, +6624198021, nutttawut@gmail.com
Nuttawut Sermsathanasawadi, MD., Ph.D
About this study
Official title: Treatment of No-option CLI Patients by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
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.
Read the 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.
- Being tested
- PB-MNC therapy, No-PB-MNC therapy
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PB-MNC therapyProcedure or surgery
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
No-PB-MNC therapyDrug
Patients will receive ASA 81 mg once daily and wound care and pain killer drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: No-PB-MNC therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation free survival
Rate of non amputated limb
Measured: 3 month
Secondary outcomes (5)
Amputation free survival
Rate of non amputated limb
Measured: 1,6,12 month
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)
Measured: 1,3,6,12 month
Toe brachial index (TBI)
Toe brachial indexThe toe brachial index is the ratio between toe pressure and the highest of the two brachial pressures
Measured: 1,3,6,12 month
Transcutaneous oxygen measurement (TCOM)
Transcutaneous oxygen measurement
Measured: 1,3,6,12 month
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.
Measured: 1,3,6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PADStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuttawut SERMSATHANASAWADI, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686228
- Sponsor's protocol ID
- SI016033012/2
- Status last verified
- Dec 2021
- First submitted
- 25 Sep 2018
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of No-option CLI Patients by G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
- ClinicalTrials.gov ID
- NCT03686228
- Acronym / sponsor ID
- SI016033012/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PB-MNC therapy | Active comparator | Procedure: PB-MNC therapyThe 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. |
| No PB-MNC therapy | Active comparator | Drug: No-PB-MNC therapyIn patients in No PB-MNC therapy, they will receive aspirin 81 mg/day and supportive treatment including wound care and pain killer drug. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with no-option CLI who presented with rest pain , non-healing ischemic ulcer and toe gangrene for 3 months
Key exclusion criteria (7 listed)
- Recent myocardial infarction
- Severe valvular heart disease
- After organ transplantation
- Cardiomyopthy( EF< 25%)
- Liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PB-MNC therapyThe 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 | Procedure or surgery | PB-MNC therapy |
| No-PB-MNC therapyPatients will receive ASA 81 mg once daily and wound care and pain killer drug | Drug | No PB-MNC therapy |
Primary outcome
Amputation free survival
Time frame: 3 month
Rate of non amputated limb
5 secondary outcomes
Amputation free survival
Time frame: 1,6,12 month
Ankle brachial index (ABI)
Time frame: 1,3,6,12 month
Toe brachial index (TBI)
Time frame: 1,3,6,12 month
Transcutaneous oxygen measurement (TCOM)
Time frame: 1,3,6,12 month
36-Item Short Form Health Survey (SF36)
Time frame: 1,3,6,12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuttawut SERMSATHANASAWADI principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PB-MNC therapy and No-PB-MNC therapy in people with PAD and Critical Limb Ischemia, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nuttawut SERMSATHANASAWADI (+66851118278, nuttawut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation free survival (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.