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

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ClinicalTrials.gov Identifier: NCT01305863
Recruitment Status : Active, not recruiting
First Posted : March 1, 2011
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Tissue Genesis, LLC

Tracking Information
First Submitted Date  ICMJE February 10, 2011
First Posted Date  ICMJE March 1, 2011
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE February 2011
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
Graft patency [ Time Frame: 6 months ]
Graft patency will be measured by duplex ultrasound.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01305863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
  • Limb salvage [ Time Frame: 12 months ]
    Amputation of limb or not
  • Wound Healing [ Time Frame: 12 months ]
    Evidence of wound improvement
  • Rest Pain [ Time Frame: 12 months ]
    Presence or absence of rest pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study of the TGI Adipose-derived Stromal Cell (ASC)-Coated ePTFE Vascular Graft
Official Title  ICMJE 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.
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lower Limb Ischemia
Intervention  ICMJE
  • 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.
    Other Name: TGI PVG
  • Device: Propaten graft
    6 mm Gore PROPATEN® graft (heparin-coated ePTFE vascular graft, thin-walled removable-ring stretch)
    Other Name: item HT060080A
Study Arms  ICMJE
  • Active Comparator: Propaten graft
    Untreated Propaten vascular graft
    Intervention: Device: Propaten graft
  • Experimental: ASC-Coated ePTFE graft
    ASC Coated BARD IMPRA® ePTFE Vascular Graft
    Intervention: Device: ASC coated ePTFE vascular graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 25, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01305863
Other Study ID Numbers  ICMJE TGI-001-01-2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tissue Genesis, LLC
Study Sponsor  ICMJE Tissue Genesis, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marvin Morris, MD The University of Louisville
PRS Account Tissue Genesis, LLC
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP