ESRDPhase 1/2NCT00850252
Use of a Lifeline Graft in the A-V Shunt Model
A Phase 1/2 study testing Lifeline in people with ESRD and Hemodialysis, run by Cytograft Tissue Engineering at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- ESRD, Hemodialysis
- What is being tested?
- Lifeline
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2004to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- A need for urgent surgery
- Penicillin allergy
- Patients with uncontrolled hypertension
- Morbid obesity (> 300 lbs)
- Active systemic infection
- Contraindication for anticoagulation
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Argentina1 site
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires
About this study
Official title: 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.
- Conditions
- ESRD, Hemodialysis
- Being tested
- Lifeline
- Keywords
- Lifeline, Tissue engineered blood vessel, A-V shunt
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifelineDevice
Also called Tissue engineered blood vessel
Surgical arteriovenous fistula formation with the use of Lifeline blood vessel
| Study group | Role | What they receive |
|---|---|---|
| Lifeline blood vessel | Experimental | Not described Receives: Device: Lifeline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary purpose of this study will be to gain preliminary safety experience with Lifeline blood vessel as an arteriovenous fistula
Measured: minimum 3 months
Secondary outcomes (1)
The secondary purpose of the study is to assess the efficacy of the Lifeline blood vessel used as hemodialysis access in ESRD patients
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startSep 2004
- Primary completionJan 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Cytograft Tissue Engineering
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Luis M de la Fuente, MD, Principal investigator, IADT, Buenos Aires, ArgentinaLech Cierpka, MD PhD, Principal investigator, Department of General, Vascular and Transplant Surgery, Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850252
- Sponsor's protocol ID
- Cytograft A-V
- Other IDs
- R44HL064462-06
- Status last verified
- Jul 2013
- First submitted
- 20 Feb 2009
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Completely Autologous and Completely Biological Tissue Engineered Blood Vessel Lifeline as an Arteriovenous Fistula in Hemodialysis Patients - Safety and Efficacy Study.
- ClinicalTrials.gov ID
- NCT00850252
- Acronym / sponsor ID
- Cytograft A-V
- Conditions
- ESRD, Hemodialysis
- Keywords
- Lifeline, Tissue engineered blood vessel, A-V shunt
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Cytograft Tissue EngineeringIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jan 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifeline blood vessel | Experimental | Device: Lifeline |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Fall into category of ASA grade 2 or below (or UK equivalent)
Key exclusion criteria (14 listed)
- A need for urgent surgery
- Penicillin allergy
- Patients with uncontrolled hypertension
- Morbid obesity (> 300 lbs)
- Active systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifelineAlso: Tissue engineered blood vesselSurgical arteriovenous fistula formation with the use of Lifeline blood vessel | Device | Lifeline blood vessel |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis M de la Fuente, MD principal investigator
IADT, Buenos Aires, Argentina
Lech Cierpka, MD PhD principal investigator
Department of General, Vascular and Transplant Surgery, Katowice, Poland
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lifeline in people with ESRD and Hemodialysis, run by Cytograft Tissue Engineering at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2013.