Critical Limb IschemiaPhase 1NCT02099500
Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
A Phase 1 study testing Liposuction and Stem Cell Injection in people with Critical Limb Ischemia, run by Ageless Regenerative Institute at 1 site in United States.
Trial summary
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for revascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Liposuction and Stem Cell Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2017
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ~ 18 years
- Existence of limb ischemia, with clinical presentation corresponding to Rutherford Categories 2-6 as defined in the reporting standards adopted by \ the Society of Vascular Surgeons, or corresponding to the Leriche-Fontaine Classification, stages II, III, or IV
- Patients with, ischemia and ischemic ulceration provided patient have angiographic evidence of vascular compromise and is not a candidate for revascularization
- Stable and on optimal medical management for > 60 days as follows:
- Clopidogrel/aspirin therapy or other anticoagulation therapy, cholesterol- lowering agent, and⁄or antihypertensive medication
- Hematocrit ≥ 28.0%, White Blood Cell count ≤14,000, Platelet count ≥ 50,000
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- Creatinine ≤ 2.5 mg/dL, and INR ≤ 1.6 (unless taking warfarin) or PTT < 1.5× control (to avoid bleeding complications). INR values for patients taking warfarin will be corrected prior to the procedure
- Patient meets at least one of the following diagnostic criteria for the index limb:
- ABI<.5mmHg
- TcpO2 <20 mm Hg when lying down and breathing room air, if available
- Or, nonhealing ulcer due to local arterial compromise with no opportunity for revascularization
- At least one non-healing distal extremity ischemic ulcer as confirmed by a vascular surgeon
- Up to date on all age and gender appropriate cancer screening per American Cancer Society
Who cannot join
- Female who is pregnant or nursing, or is of childbearing potential and not using a reliable method of contraception
- Any medical problems contraindicating tumescent syringe liposuction
- Life expectancy < 6 months
- Patient determined to be nonsurgical candidate due to reasons such as
- High-risk medical conditions
- Unstable cardiac disease
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- Stroke or transient ischemic attack leading to limitations in lower extremities or occurring within 180 days prior to the initial screening visit
- Severe arthritis or other musculoskeletal disorder.
- Systolic blood pressure (supine) ≤ 90 mmHg
- Resting heart rate > 100 bpm
- Poorly controlled diabetes mellitus (HgbA1c > 10%)
- Life-threatening complications of limb ischemia necessitating immediate amputation
- Uncorrected iliac artery occlusion on index side unless corrected with stent
- Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6)
- Active clinical infection within one week of enrollment
- Treatment with immunosuppressant drugs
- Known drug or alcohol dependence, or any other factors which will interfere with the study conduct or interpretation of the results
- Not suitable to participate in the opinion of the principal investigator
- History cancer (other than non-melanoma skin cancer or in situ cervical cancer) within five years preceding study entry
- Unwilling and/or not able to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Non-Randomized, Patient Funded, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for revascularization.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for intramuscular injection into the lower limb.
- Conditions
- Critical Limb Ischemia
- Being tested
- Liposuction, Stem Cell Injection
- Keywords
- Critical Limb Ischemia, Peripheral Vascular Disease, Lower Limb Ulcer, Gangrene, Amputation, Lower Limb Wound
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Vascular Diseases, Leg Ulcer, Gangrene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiposuctionProcedure or surgery
Also called Adipose-Derived Stem Cells
Liposuction using aspiration syringe and tumescent local anesthesia
Stem Cell InjectionOther
Stem cell implantation will be performed using intramuscular injection into the affected ischemic site of interest
| Study group | Role | What they receive |
|---|---|---|
| Stem Cell Injection | Experimental | Non-Randomized Receives: Procedure: Liposuction; Other: Stem Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement from baseline in perfusion as measured by ankle-brachial index and collateral artery number
Contrast Angiography
Measured: 6 months
Number of adverse events reported
Measured: 6 months
Secondary outcomes (2)
Improvement from baseline in improvement or resolution of ulcer or gangrene
Visual assessment
Measured: 3 months, 6 months
Limb Salvage
Assessed with doppler to measure blood flow to the affected area.
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: no participants enrolled
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ageless Regenerative Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon McQuillan, MD, Principal investigator, Ageless Regenerative Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099500
- Sponsor's protocol ID
- ADI-US-CLIN-001
- Status last verified
- Jul 2017
- First submitted
- 19 Mar 2014
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-Randomized, Patient Funded, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Via Intramuscular Injections for the Treatment of Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02099500
- Acronym / sponsor ID
- ADI-US-CLIN-001
- Conditions
- Critical Limb Ischemia
- Keywords
- Critical Limb Ischemia, Peripheral Vascular Disease, Lower Limb Ulcer, Gangrene, Amputation, Lower Limb Wound
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ageless Regenerative InstituteIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 31 Mar 2014 (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.
This is an open-label, non-randomized, multi center, patient sponsored study of Adipose-Derived Stromal Cell (ASC) implantation via intramuscular injections in patients who have critical limb ischemia not amenable for revascularization.
The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed critical limb ischemia ASCs will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for intramuscular injection into the lower limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem Cell Injection | Experimental | Procedure: Liposuction, Other: Stem Cell InjectionNon-Randomized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ~ 18 years
- Existence of limb ischemia, with clinical presentation corresponding to Rutherford Categories 2-6 as defined in the reporting standards adopted by \ the Society of Vascular Surgeons, or corresponding to the Leriche-Fontaine Classification, stages II, III, or IV
- Patients with, ischemia and ischemic ulceration provided patient have angiographic evidence of vascular compromise and is not a candidate for revascularization
- Stable and on optimal medical management for > 60 days as follows:
- Clopidogrel/aspirin therapy or other anticoagulation therapy, cholesterol- lowering agent, and⁄or antihypertensive medication
Key exclusion criteria (20 listed)
- Female who is pregnant or nursing, or is of childbearing potential and not using a reliable method of contraception
- Any medical problems contraindicating tumescent syringe liposuction
- Life expectancy < 6 months
- Patient determined to be nonsurgical candidate due to reasons such as
- Systolic blood pressure (supine) ≤ 90 mmHg
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 |
|---|---|---|
| LiposuctionAlso: Adipose-Derived Stem CellsLiposuction using aspiration syringe and tumescent local anesthesia | Procedure or surgery | Stem Cell Injection |
| Stem Cell InjectionStem cell implantation will be performed using intramuscular injection into the affected ischemic site of interest | Other | Stem Cell Injection |
Primary outcome
Improvement from baseline in perfusion as measured by ankle-brachial index and collateral artery number
Time frame: 6 months
Contrast Angiography
Number of adverse events reported
Time frame: 6 months
2 secondary outcomes
Improvement from baseline in improvement or resolution of ulcer or gangrene
Time frame: 3 months, 6 months
Limb Salvage
Time frame: 3 months and 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Sharon McQuillan, MD principal investigator
Ageless Regenerative Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Liposuction and Stem Cell Injection in people with Critical Limb Ischemia, run by Ageless Regenerative Institute at 1 site in United States.
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 13 inclusion and 20 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: withdrawn, as of the sponsor's last update on 21 Jul 2017. 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 United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Improvement from baseline in perfusion as measured by ankle-brachial index and collateral artery number (time frame: 6 months). The study lists 2 primary outcomes in all. 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 21 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.