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

NCT01305863 | Unknown DMC

• 1 other identifier: TGI-001-01-2008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Peripheral Vascular Disease (PVD)

Outcome Measures

Primary Outcomes (1)

• Graft patency

  Graft patency will be measured by duplex ultrasound.

  6 months

Secondary Outcomes (3)

• Limb salvage

  12 months

• Wound Healing

  12 months

• Rest Pain

  12 months

Study Arms (2)

Propaten graft

ACTIVE COMPARATOR

Untreated Propaten vascular graft

Device: Propaten graft

ASC-Coated ePTFE graft

EXPERIMENTAL

ASC Coated BARD IMPRA® ePTFE Vascular Graft

Device: ASC coated ePTFE vascular graft

Interventions

ASC coated ePTFE vascular graft DEVICE

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.

Also known as: TGI PVG

ASC-Coated ePTFE graft

Propaten graft DEVICE

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

Also known as: item HT060080A

Propaten graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Tissue Genesis: lead

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marvin Morris, MD

  The University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: March 1, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

US (1)