Critical Limb IschemiaPhase 3NCT01833585
Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
A Phase 3 study testing Peripheral blood mononuclear cell in people with Critical Limb Ischemia and Atherosclerosis, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer
- What is being tested?
- Peripheral blood mononuclear cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2013to Dec 2017
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with critical limb ischemia confirmed by toe pressure, ABI, TCOM
- Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion
- Poor distal artery runoff
- Age 18-70 year
Who cannot join
- Planned for major amputation within 4 weeks
- Receive blood component within 4 weeks
- Acute myocardial infarction
- severe valvular heart disease
- renal failure
- liver failure
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- Cancer
- Hypercoagulable state
- Severe infection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Vascular Surgery, Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
Official title: Pilot Study of Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.
- Conditions
- Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer, Gangrene
- Being tested
- Peripheral blood mononuclear cell
- Keywords
- critical limb ischemia, atherosclerosis, ischemic ulcer, rest pain, gangrene
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Atherosclerosis, Gangrene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood mononuclear cellBiological
Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia
| Study group | Role | What they receive |
|---|---|---|
| peripheral blood mononuclear cells | Experimental | peripheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia Receives: Biological: Peripheral blood mononuclear cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients without major amputation after mononuclear cell injection
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuttawut Sermsathanasawadi, MD.,Ph.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833585
- Sponsor's protocol ID
- SIRIRAJR015533013
- Status last verified
- Aug 2018
- First submitted
- 9 Apr 2013
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Treatment of Chronic Critical Limb Ischemia With G-CSF-mobilized Autologous Peripheral Blood Mononuclear Cells
- ClinicalTrials.gov ID
- NCT01833585
- Acronym / sponsor ID
- SIRIRAJR015533013
- Conditions
- Critical Limb Ischemia, Atherosclerosis, Ischemic Ulcer, Gangrene
- Keywords
- critical limb ischemia, atherosclerosis, ischemic ulcer, rest pain, gangrene
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 Apr 2013 (estimated)
- 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.
The purpose of this study is to determine the safety and efficacy of G-CSF-mobilized autologous peripheral blood mononuclear cell injection to ischemic limbs of patients with critical limb ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peripheral blood mononuclear cells | Experimental | Biological: Peripheral blood mononuclear cellperipheral blood mononuclear cells will be injected to calf muscle of critical limb ischemia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with critical limb ischemia confirmed by toe pressure, ABI, TCOM
- Levels of arterial occlusion are femoropopliteal or tibioperoneal occlusion
- Poor distal artery runoff
- Age 18-70 year
Key exclusion criteria (10 listed)
- Planned for major amputation within 4 weeks
- Receive blood component within 4 weeks
- Acute myocardial infarction
- severe valvular heart disease
- renal 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 |
|---|---|---|
| Peripheral blood mononuclear cellPeripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia | Biological | peripheral blood mononuclear cells |
Primary outcome
Number of patients without major amputation after mononuclear cell injection
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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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, MD.,Ph.D. 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 Phase 3 study testing Peripheral blood mononuclear cell in people with Critical Limb Ischemia and Atherosclerosis, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 17 Aug 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients without major amputation after mononuclear cell injection (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 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.