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

NCT01305863 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-06-24

No results posted yet for this study

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. 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.

Conditions

  • Lower Limb Ischemia

Interventions

DEVICE

ASC coated ePTFE vascular graft

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.

DEVICE

Propaten graft

6 mm Gore PROPATEN® graft (heparin-coated ePTFE vascular graft, thin-walled removable-ring stretch)

Sponsors & Collaborators

  • Tissue Genesis

    lead INDUSTRY

Principal Investigators

  • Marvin Morris, MD · The University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2022-04-30
Completion
2022-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01305863 on ClinicalTrials.gov