Use of a Lifeline Graft in the A-V Shunt Model

July 15, 2013 updated by: Cytograft Tissue Engineering

Use of a Completely Autologous and Completely Biological Tissue Engineered Blood Vessel Lifeline as an Arteriovenous Fistula in Hemodialysis Patients - Safety and Efficacy Study.

This study will assess the safety and efficacy of a completely autologous and completely biological tissue engineered blood vessel (TEBV) called Lifeline™ used as an arteriovenous fistula for dialysis access.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Instituto Argentino de Diagnostico y Tratamiento
  • Poland
      • Katowice, Poland
        • Department of General, Vascular and Transplant Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have signed an informed consent
  • Patients ≥ 21 years old
  • Patients not candidates for a Brescia-Cimino A-V fistula (own vessels)

  • Have an AV shunt or fistula that will likely fail within 12 months because of:

    • Signs of clinical dysfunction: increment of venous pressure, limited site of puncture, stenosis, aneurysm dilatations that cannot be surgically repaired or by other media, or
    • Previous angioplasty, or
    • Previous thrombolysis
  • Fall into category of ASA grade 2 or below (or UK equivalent)
  • Are willing and able to comply with 2, 4, 6, 8, 10, 12, 16, 20, 24, 36 and 52 week follow up and able to comply with biannual follow up thereafter.

Exclusion Criteria:

  • A need for urgent surgery
  • Penicillin allergy
  • Patients with uncontrolled hypertension
  • Morbid obesity (> 300 lbs)
  • Active systemic infection
  • Contraindication for anticoagulation
  • Coagulopathy
  • Acute renal failure
  • Connective tissue diseases (i.e. Marfan's syndrome)
  • Pregnant or nursing
  • Life expectancy < 1 year
  • Participation in another study involving an investigational device or new drug
  • Other medical, social or psychological issues that, in the opinion of the principal investigator, preclude them from receiving the treatment and the procedures/evaluations of the post-operative follow up
  • Inability or unwillingness to comply with the scheduled follow-up visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifeline blood vessel
Device: Lifeline
Surgical arteriovenous fistula formation with the use of Lifeline blood vessel
Other Names:
  • Tissue engineered blood vessel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula
Time Frame: minimum 3 months
minimum 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary purpose of the study is to assess the efficacy of the Lifeline blood vessel used as hemodialysis access in ESRD patients
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cytograft Tissue Engineering

Investigators

  • Principal Investigator: Luis M de la Fuente, MD, IADT, Buenos Aires, Argentina
  • Principal Investigator: Lech Cierpka, MD PhD, Department of General, Vascular and Transplant Surgery, Katowice, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 20, 2009

First Submitted That Met QC Criteria

February 20, 2009

First Posted (Estimate)

February 24, 2009

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Cytograft A-V
  • R44HL064462-06 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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