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.
| City: |
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Louisville |
| State: |
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Kentucky |
| Zip Code: |
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40202 |
| Conditions: |
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Lower Limb Ischemia |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
1. Male or female ≥ 18 years old
2. 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).
3. The distal anastomosis must be no more distal than approximately the midcalf.
4. Rutherford-Baker classification for acute peripheral arterial disease of category 5
or less.
5. 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.
6. The distal target vessel must have continuous blood flow to the foot; an
arteriovenous fistula must not be created at the distal anastomosis.
Exclusion Criteria:
1. Proximal anastomosis above the inguinal ligament.
2. Distal anastomosis below the mid-calf.
3. Lack of adequate subcutaneous fat stores to allow liposuction of 120 mL of adipose
tissue.
4. Limb-threatening acute ischemia in the affected leg.
5. Active infection at the time of implantation.
6. Uncontrolled diabetes.
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| NCT ID: |
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NCT01305863 |
| Primary Contact: |
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Principal Investigator
Charles Ross, MD
The University of Louisville
Misty Hooper, CPA
Phone: 502-852-2904
Email: mlhoop01@louisville.edu
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| Backup Contact: |
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Email: charles.ross@louisville.edu
Charles B Ross, MD
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| Location Contact: |
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Louisville, Kentucky 40202
United States
Charles B Ross, MD
Email: charles.ross@louisville.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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