Lower Limb IschemiaTGI-PVG-IDENCT01305863
Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft
A study testing ASC coated ePTFE vascular graft and Propaten graft in people with Lower Limb Ischemia, run by Tissue Genesis at 1 site in United States.
Trial summary
Researchers are actively seeking a way to coat the inside of a synthetic graft so that it more closely resembles native vessels and therefore has low thrombogenicity and low incidence of stenosis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Ischemia
- What is being tested?
- ASC coated ePTFE vascular graft and Propaten graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years old
- Patient has a clinical diagnosis of Peripheral Vascular Disease (PVD) and requires a synthetic vascular graft, with the distal anastomosis to a tibial artery (peroneal, anterior tibial, posterior tibial).
- The distal anastomosis must be no more distal than approximately the midcalf.
- Rutherford-Baker classification for acute peripheral arterial disease of category 5 or less.
- The proximal anastomosis must be in the common femoral artery (CFA) or the superficial femoral artery (SFA); the proximal anastomosis must not be above the inguinal ligament.
- The distal target vessel must have continuous blood flow to the foot; an arteriovenous fistula must not be created at the distal anastomosis.
Who cannot join
- Proximal anastomosis above the inguinal ligament.
- Distal anastomosis below the mid-calf.
- Lack of adequate subcutaneous fat stores to allow liposuction of 120 mL of adipose tissue.
- Limb-threatening acute ischemia in the affected leg.
- Active infection at the time of implantation.
- Uncontrolled diabetes.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: A Randomized, Controlled, Parallel Group, Blinded, Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft for Femoral-tibial Bypass Grafting.
Researchers are actively seeking a way to coat the inside of a synthetic graft so that it more closely resembles native vessels and therefore has low thrombogenicity and low incidence of stenosis. Using a biological coating comprised of autologous stromal cells derived from the patient's own adipose tissue is a logical solution. Considerable experimental evidence exists that such a coating is relatively non-thrombogenic and improves long-term graft patency.
The Company's TGI Cell Isolation System (CIS) for isolating and concentrating adipose-derived stromal cells (ASC) can be used to fill the pressing medical need for small-diameter synthetic vascular grafts. The TGI CIS enables the user to prepare a stem cell-based biological coating from adipose tissue liposuctioned from the patient. The cells derived from the adipose tissue are then sodded onto the internal lumen of the vascular graft to improve long term patency.
Read the detailed description
Replacement or bypass of small diameter (< 4-5 mm) blood vessels is needed for a variety of medical problems, including peripheral vascular disease (PVD) associated with diabetes, generalized atherosclerosis, or aging), and critical limb ischemia (CLI). Vascular surgery has been extremely successful in replacing damaged or atherosclerotic arteries that are large in diameter and associated with high flow rates. However, as the diameter of the damaged vessel decreases, the ability to achieve long-term patency using replacement vessels decreases. The best current solution to this phenomenon of decreased patency with decreasing vessel diameter has been the use of the saphenous vein bypass graft. The saphenous vein has become the benchmark of all smaller diameter vascular grafts and demonstrates excellent patency when used from the femoral artery to the popliteal artery below the knee. However, when extended to more distal locations including the tibial arteries, even the saphenous vein begins to demonstrate limitations in its ability to maintain long-term patency.
The TGI ASC-coated expanded polytetrafluoroethylene (ePTFE) Vascular Graft is an adipose-derived stromal cell-sodded small-diameter vascular conduit intended for use as a peripheral bypass graft. The autologous cells used to create the ASC-coated vascular graft are isolated by the TGI Cell Isolation System (CIS). The TGI ASC-coated graft can be used to address the pressing medical need for small-diameter vascular grafts with improved long-term patency rates. The TGI CIS enables the user to prepare a stem cell-based biological coating in about an hour; stromal cells isolated from adipose tissue are sodded onto the internal lumen of the vascular graft before it is implanted into the patient during the course of a peripheral vascular bypass procedure.
The TGI Peripheral Vascular Graft (PVG) Kit consists of a vascular conduit, a proprietary enzymatic solution (Adipase™ Custom Enzyme Solution), and a disposable fluidics system, all to be used in conjunction with the TGI CIS, itself an automated point-of-care tissue processing instrument which isolates ASCs from a lipoaspirate specimen. Such cells are administered onto the lumen of the prepared conduit, a commercially available, small-diameter ePTFE straight vascular graft (IMPRA ePTFE Vascular Graft, item 80s06, Bard Peripheral Vascular, Inc.)
This instrument system will provide a sterile flow-path, through which cells are processed and separated. The flow-path is contained within a disposable cartridge that interlocks with the durable system hardware and includes both a flow-path cartridge with fluid reservoirs and a disposable centrifuge cartridge. The system is a self contained, stand-alone system requiring only AC power to operate.
The clinical trial process will involve a pilot (or feasibility) study to gain initial safety and effectiveness data in a limited human population. A subsequent pivotal study will be conducted with sufficient patient numbers to demonstrate a statistically significant improvement in effectiveness for defined clinical endpoints and to gain important safety information in a specific clinical population.
- Conditions
- Lower Limb Ischemia
- Being tested
- ASC coated ePTFE vascular graft, Propaten graft
- Keywords
- Peripheral Vascular Disease (PVD)
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC coated ePTFE vascular graftDevice
Also called TGI PVG
An ePTFE vascular graft in which the lumen of the graft has been coated with an autologous coating of adipose-derived stromal cells (ASC) prepared using an automated point-of-care processing instrument to facilitate isolation and concentration of autologous adipose-derived stromal cells and subsequent sodding of small-diameter vascular grafts.
Propaten graftDevice
Also called item HT060080A
6 mm Gore PROPATEN® graft (heparin-coated ePTFE vascular graft, thin-walled removable-ring stretch)
| Study group | Role | What they receive |
|---|---|---|
| Propaten graft | Active comparator | Untreated Propaten vascular graft Receives: Device: Propaten graft |
| ASC-Coated ePTFE graft | Experimental | ASC Coated BARD IMPRA® ePTFE Vascular Graft Receives: Device: ASC coated ePTFE vascular graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency
Graft patency will be measured by duplex ultrasound.
Measured: 6 months
Secondary outcomes (3)
Limb salvage
Amputation of limb or not
Measured: 12 months
Wound Healing
Evidence of wound improvement
Measured: 12 months
Rest Pain
Presence or absence of rest pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tissue Genesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marvin Morris, MD, Principal investigator, The University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305863
- Sponsor's protocol ID
- TGI-001-01-2008
- Acronym
- TGI-PVG-IDE
- Status last verified
- Jun 2021
- First submitted
- 10 Feb 2011
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
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
- A Randomized, Controlled, Parallel Group, Blinded, Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft for Femoral-tibial Bypass Grafting.
- ClinicalTrials.gov ID
- NCT01305863
- Acronym / sponsor ID
- TGI-PVG-IDE / TGI-001-01-2008
- Conditions
- Lower Limb Ischemia
- Keywords
- Peripheral Vascular Disease (PVD)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tissue GenesisIndustry (pharma, biotech, devices)
- Study start
- Feb 2011 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 1 Mar 2011 (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.
Researchers are actively seeking a way to coat the inside of a synthetic graft so that it more closely resembles native vessels and therefore has low thrombogenicity and low incidence of stenosis. Using a biological coating comprised of autologous stromal cells derived from the patient's own adipose tissue is a logical solution. Considerable experimental evidence exists that such a coating is relatively non-thrombogenic and improves long-term graft patency.
The Company's TGI Cell Isolation System (CIS) for isolating and concentrating adipose-derived stromal cells (ASC) can be used to fill the pressing medical need for small-diameter synthetic vascular grafts. The TGI CIS enables the user to prepare a stem cell-based biological coating from adipose tissue liposuctioned from the patient. The cells derived from the adipose tissue are then sodded onto the internal lumen of the vascular graft to improve long term patency.
Detailed description
Replacement or bypass of small diameter (< 4-5 mm) blood vessels is needed for a variety of medical problems, including peripheral vascular disease (PVD) associated with diabetes, generalized atherosclerosis, or aging), and critical limb ischemia (CLI). Vascular surgery has been extremely successful in replacing damaged or atherosclerotic arteries that are large in diameter and associated with high flow rates. However, as the diameter of the damaged vessel decreases, the ability to achieve long-term patency using replacement vessels decreases. The best current solution to this phenomenon of decreased patency with decreasing vessel diameter has been the use of the saphenous vein bypass graft. The saphenous vein has become the benchmark of all smaller diameter vascular grafts and demonstrates excellent patency when used from the femoral artery to the popliteal artery below the knee. However, when extended to more distal locations including the tibial arteries, even the saphenous vein begins to demonstrate limitations in its ability to maintain long-term patency.
The TGI ASC-coated expanded polytetrafluoroethylene (ePTFE) Vascular Graft is an adipose-derived stromal cell-sodded small-diameter vascular conduit intended for use as a peripheral bypass graft. The autologous cells used to create the ASC-coated vascular graft are isolated by the TGI Cell Isolation System (CIS). The TGI ASC-coated graft can be used to address the pressing medical need for small-diameter vascular grafts with improved long-term patency rates. The TGI CIS enables the user to prepare a stem cell-based biological coating in about an hour; stromal cells isolated from adipose tissue are sodded onto the internal lumen of the vascular graft before it is implanted into the patient during the course of a peripheral vascular bypass procedure.
The TGI Peripheral Vascular Graft (PVG) Kit consists of a vascular conduit, a proprietary enzymatic solution (Adipase™ Custom Enzyme Solution), and a disposable fluidics system, all to be used in conjunction with the TGI CIS, itself an automated point-of-care tissue processing instrument which isolates ASCs from a lipoaspirate specimen. Such cells are administered onto the lumen of the prepared conduit, a commercially available, small-diameter ePTFE straight vascular graft (IMPRA ePTFE Vascular Graft, item 80s06, Bard Peripheral Vascular, Inc.)
This instrument system will provide a sterile flow-path, through which cells are processed and separated. The flow-path is contained within a disposable cartridge that interlocks with the durable system hardware and includes both a flow-path cartridge with fluid reservoirs and a disposable centrifuge cartridge. The system is a self contained, stand-alone system requiring only AC power to operate.
The clinical trial process will involve a pilot (or feasibility) study to gain initial safety and effectiveness data in a limited human population. A subsequent pivotal study will be conducted with sufficient patient numbers to demonstrate a statistically significant improvement in effectiveness for defined clinical endpoints and to gain important safety information in a specific clinical population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propaten graft | Active comparator | Device: Propaten graftUntreated Propaten vascular graft |
| ASC-Coated ePTFE graft | Experimental | Device: ASC coated ePTFE vascular graftASC Coated BARD IMPRA® ePTFE Vascular Graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female ≥ 18 years old
- Patient has a clinical diagnosis of Peripheral Vascular Disease (PVD) and requires a synthetic vascular graft, with the distal anastomosis to a tibial artery (peroneal, anterior tibial, posterior tibial).
- The distal anastomosis must be no more distal than approximately the midcalf.
- Rutherford-Baker classification for acute peripheral arterial disease of category 5 or less.
- The proximal anastomosis must be in the common femoral artery (CFA) or the superficial femoral artery (SFA); the proximal anastomosis must not be above the inguinal ligament.
Key exclusion criteria (6 listed)
- Proximal anastomosis above the inguinal ligament.
- Distal anastomosis below the mid-calf.
- Lack of adequate subcutaneous fat stores to allow liposuction of 120 mL of adipose tissue.
- Limb-threatening acute ischemia in the affected leg.
- Active infection at the time of implantation.
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 |
|---|---|---|
| ASC coated ePTFE vascular graftAlso: TGI PVGAn ePTFE vascular graft in which the lumen of the graft has been coated with an autologous coating of adipose-derived stromal cells (ASC) prepared using an automated point-of-care processing instrument to facilitate isolation and concentration of autologous adipose-derived stromal cells and subsequent sodding of small-diameter vascular grafts. | Device | ASC-Coated ePTFE graft |
| Propaten graftAlso: item HT060080A6 mm Gore PROPATEN® graft (heparin-coated ePTFE vascular graft, thin-walled removable-ring stretch) | Device | Propaten graft |
Primary outcome
Graft patency
Time frame: 6 months
Graft patency will be measured by duplex ultrasound.
3 secondary outcomes
Limb salvage
Time frame: 12 months
Wound Healing
Time frame: 12 months
Rest Pain
Time frame: 12 months
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.
Marvin Morris, MD principal investigator
The University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASC coated ePTFE vascular graft and Propaten graft in people with Lower 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 6 inclusion and 6 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?
Graft patency (time frame: 6 months). 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.