Critical Limb IschemiaCLI-DINCT02234778
Evaluation of the Tissue Genesis® Icellator Cell Isolation System™ to Treat Critical Limb Ischemia
A study testing TGI SVF material via intramuscular injection in people with Critical Limb Ischemia, run by Tissue Genesis at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device removes certain cells from the adipose (fat) tissue which will be used to treat patients with blockages in the arteries of their lower… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- TGI SVF material via intramuscular injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critical limb ischemia (CLI), defined as ischemic pain at rest (Rutherford Category 4) or minor tissue loss of the limb (Rutherford Category 5), and with either toe artery occlusive pressure < 50 mmHg or TBI ≤ 0.5 or ankle artery occlusion pressure ≤ 60 mm Hg or ABI ≤ 0.5
- No reasonable open or endovascular surgical options as determined by treating vascular specialist
- Competent to give consent
- Age 21 years or greater
- Females of child bearing potential agree to use acceptable methods of contraception for the duration of the trial. Sexually active males agree to use an accepted and effective method of contraception for the duration of the trial.
- All diabetic subjects will undergo baseline and 12-month follow-up retinal examinations conducted by a specialist
- No current malignancy or history of previous malignancy within the last five years, with the exception of adequately treated non-melanoma cutaneous carcinoma (basal cell or squamous cell carcinoma of the skin).
Who cannot join
- Major tissue loss of the index limb (Rutherford Category 6)
- Limb revascularization surgery within 45 days of enrollment in this study
- Subjects with less than 15% body fat as measured by calipers or electrical impedance
- Subjects with less than a 2 cm x 2 cm roll of subcutaneous abdominal fat, when pinched between the examiner's fingers, while the subject is in a supine position
- Poorly controlled diabetes mellitus evidenced by HbA1C > 10%. Diabetic subjects must have evidence of a glycosylated hemoglobin test (HbA1C) performed within the last 30 days.
- Uncompensated congestive heart failure (New York Heart Association Class IV) and/or other conditions that preclude general anesthesia.
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- Myocardial infarction or stroke within the last 90 days.
- Elevated liver function tests (AST or ALT more than twice the upper limit of normal).
- Hematologic abnormalities.
- Disease of the central nervous system and/or other conditions that impair cognitive function.
- History of two or more episodes of pulmonary embolus with a documented deep venous thrombosis (DVT) (Duplex US or venography) in the index extremity or history of DVT in the index extremity without evidence of clot resolution (Duplex US or venography)
- Infection of the index leg
- Pregnant or lactating females. Prior to enrollment, women of child-bearing potential must have a negative urine pregnancy test.
- Lower extremity venous disease or lymphedema with pitting edema in the index leg
- Osteomyelitis in the index leg
- Existing HIV diagnosis
- Known terminal disease process with a life expectancy of less than one year
- Subjects, in the investigator's opinion, requiring amputation within 30 days
- Uncorrected stenosis(es) of greater than 50% in the common and/or external iliac artery and/or common femoral artery of the index leg
- Presence of any clinical condition that in the opinion of the PI or the sponsor makes the patient not suitable to participate in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System™ for Autologous Adipose-Derived Stromal Vascular Fraction Cells to Treat Critical Limb Ischemia
The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device removes certain cells from the adipose (fat) tissue which will be used to treat patients with blockages in the arteries of their lower legs that may require a future amputation, which is caused by severe peripheral artery disease (PAD). The purpose of this study is to determine if treatment with cells that have been removed from the Icellator System™ device will reduce the number of major amputations and deaths in a six month time period.
- Conditions
- Critical Limb Ischemia
- Being tested
- TGI SVF material via intramuscular injection
- Keywords
- critical limb ischemia, autologous stromal vascular fraction
- 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.
TGI SVF material via intramuscular injectionDevice
Each SVF-treated subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period.
| Study group | Role | What they receive |
|---|---|---|
| Study Treatment | Experimental | Each subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period. TGI SVF material injection will be completed within 4 hours of cell separation. Receives: Device: TGI SVF material via intramuscular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation-Free Survival
To obtain preliminary feasibility evidence of the ability of the Tissue Genesis Inc. (TGI) stromal vascular fraction (SVF) material to result in freedom from major amputation (above the ankle) or death at 26 weeks following treatment. Treatment failure is defined as the composite of major amputation of the treatment limb or all-cause death.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tissue Genesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234778
- Sponsor's protocol ID
- TGI-002-01-2013
- Acronym
- CLI-DI
- Status last verified
- Jun 2021
- First submitted
- 4 Sep 2014
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of the Tissue Genesis® Icellator Cell Isolation System™ for Autologous Adipose-Derived Stromal Vascular Fraction Cells to Treat Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02234778
- Acronym / sponsor ID
- CLI-DI / TGI-002-01-2013
- Conditions
- Critical Limb Ischemia
- Keywords
- critical limb ischemia, autologous stromal vascular fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tissue GenesisIndustry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 9 Sep 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.
The purpose of this study is to determine the safety and effectiveness of the Tissue Genesis® Icellator Cell Isolation System™ in Critical Limb Ischemia. The Icellator System™ device removes certain cells from the adipose (fat) tissue which will be used to treat patients with blockages in the arteries of their lower legs that may require a future amputation, which is caused by severe peripheral artery disease (PAD). The purpose of this study is to determine if treatment with cells that have been removed from the Icellator System™ device will reduce the number of major amputations and deaths in a six month time period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Treatment | Experimental | Device: TGI SVF material via intramuscular injectionEach subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period. TGI SVF material injection will be completed within 4 hours of cell separation. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Critical limb ischemia (CLI), defined as ischemic pain at rest (Rutherford Category 4) or minor tissue loss of the limb (Rutherford Category 5), and with either toe artery occlusive pressure < 50 mmHg or TBI ≤ 0.5 or ankle artery occlusion pressure ≤ 60 mm Hg or ABI ≤ 0.5
- No reasonable open or endovascular surgical options as determined by treating vascular specialist
- Competent to give consent
- Age 21 years or greater
- Females of child bearing potential agree to use acceptable methods of contraception for the duration of the trial. Sexually active males agree to use an accepted and effective method of contraception for the duration of the trial.
Key exclusion criteria (20 listed)
- Major tissue loss of the index limb (Rutherford Category 6)
- Limb revascularization surgery within 45 days of enrollment in this study
- Subjects with less than 15% body fat as measured by calipers or electrical impedance
- Subjects with less than a 2 cm x 2 cm roll of subcutaneous abdominal fat, when pinched between the examiner's fingers, while the subject is in a supine position
- Poorly controlled diabetes mellitus evidenced by HbA1C > 10%. Diabetic subjects must have evidence of a glycosylated hemoglobin test (HbA1C) performed within the last 30 days.
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 |
|---|---|---|
| TGI SVF material via intramuscular injectionEach SVF-treated subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period. | Device | Study Treatment |
Primary outcome
Amputation-Free Survival
Time frame: 26 weeks
To obtain preliminary feasibility evidence of the ability of the Tissue Genesis Inc. (TGI) stromal vascular fraction (SVF) material to result in freedom from major amputation (above the ankle) or death at 26 weeks following treatment. Treatment failure is defined as the composite of major amputation of the treatment limb or all-cause death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TGI SVF material via intramuscular injection in people with Critical Limb Ischemia, run by Tissue Genesis 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 7 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: status not confirmed, as of the sponsor's last update on 24 Jun 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 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.
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?
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?
Amputation-Free Survival (time frame: 26 weeks). 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 24 Jun 2021.