Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft

Status unconfirmed · Not applicable

Conditions studied: Lower Limb Ischemia

In brief

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.

Key facts

Study ID

NCT01305863

Run by

Tissue Genesis

People needed

60

Starts

2011-02-01

Expected to finish

2022-05-01

Last updated by the study team

2021-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Louisville Hospital — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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