100 Participants Needed

Decellularized Femoral Artery Transplant for Chronic Kidney Failure

(NexeonAVX Trial)

Recruiting at 3 trial locations
KD
AB
MA
MA
Overseen ByMark Archie, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: LifeNet Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a known sensitivity to certain antibiotics or processing reagents used in the trial, you may be excluded from participating.

Is the Nexeon AVX Decellularized Femoral Artery generally safe for use in humans?

Research on decellularized engineered allografts in sheep shows that these grafts remained open and functional without complications like dilatation or mineralization over 24 weeks, suggesting they are generally safe. However, this data is from animal studies, and human-specific safety data is not provided.12345

How is the Nexeon AVX Decellularized Femoral Artery Allograft treatment different from other treatments for chronic kidney failure?

The Nexeon AVX Decellularized Femoral Artery Allograft is unique because it uses a decellularized artery, which means all cellular components are removed to reduce immune reactions, making it potentially more biocompatible and less likely to be rejected by the body compared to synthetic or traditional grafts.12678

What data supports the effectiveness of the treatment Nexeon AVX Decellularized Femoral Artery Allograft for chronic kidney failure?

Research on similar treatments, like human acellular vessels and tissue-engineered vascular grafts, shows promise in improving safety and effectiveness for hemodialysis access in patients with kidney failure. These treatments have been used successfully in complex cases where traditional options are not viable, suggesting potential benefits for the Nexeon AVX Decellularized Femoral Artery Allograft.19101112

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with end-stage renal disease (ESRD) or kidney dysfunction requiring hemodialysis. Participants need dialysis access, must understand the study's demands, provide written consent, and not be in another drug/device study. Those with severe heart issues, recent myocardial infarction, arrhythmias, unstable angina needing treatment, severe vascular disease in arms or unable to follow the visit schedule are excluded.

Inclusion Criteria

I need a way to start or keep getting dialysis, and placing a graft for access is possible for me.
Have provided written authorization for use and disclosure of protected health information
I have severe kidney disease or am on dialysis.
See 1 more

Exclusion Criteria

I have severe blood circulation problems in my arms.
I have severe heart issues or had a heart attack in the last 6 months.
Have the presence of any condition that, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the decellularized femoral artery allograft for vascular access creation

Procedure day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including ultrasound evaluations of allograft patency

24 months
Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Nexeon AVX Decellularized Femoral Artery
Trial Overview The trial tests a new type of graft called Nexeon AVX Decellularized Femoral Artery for people who require dialysis due to kidney failure. It aims to determine if this graft is safe and effective as a means of accessing the bloodstream for hemodialysis treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention

Nexeon AVX Decellularized Femoral Artery is already approved in United States for the following indications:

🇺🇸
Approved in United States as Nexeon AVX Decellularized Femoral Artery Allograft for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

LifeNet Health

Lead Sponsor

Trials
15
Recruited
1,200+

Published Research Related to This Trial

The use of human acellular vessels (HAV) as a conduit for vascular access in hemodialysis shows promise in improving safety and efficacy for patients with end-stage renal disease, particularly in complex cases where standard options are limited.
In a high-risk population with significant comorbidities, the technical success of surgeries using HAV for aneurysm repairs suggests that this regenerative medicine approach could expand treatment options for patients needing vascular access.
Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair.Nickerson, MC., Thamba, A., Rao, V., et al.[2023]
Intensified decellularization of equine carotid arteries (int-dEAC) maintains essential biomechanical properties like suture retention strength and burst pressure, making them suitable for use as vascular grafts in haemodialysis patients.
Both decellularization methods significantly reduced glycosaminoglycan content but did not induce cytotoxicity, indicating that int-dEAC can effectively serve as a scaffold for vascular tissue engineering without harming endothelial cells.
Effect of Intensified Decellularization of Equine Carotid Arteries on Scaffold Biomechanics and Cytotoxicity.Böer, U., Hurtado-Aguilar, LG., Klingenberg, M., et al.[2015]
Translumbar tunneled dialysis catheters (TLDC) were successfully placed in all 12 patients studied, providing a viable option for those with vascular access failure in hemodialysis.
While there were some complications, including a 41.6% rate of catheter-related infections, the TLDC showed good patency rates, with 91% remaining patent at 3 months, indicating it can effectively support patient survival and serve as a bridge to renal transplantation.
Translumbar hemodialysis long-term catheters: an alternative for vascular access failure.Moura, F., Guedes, FL., Dantas, Y., et al.[2020]

Citations

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair. [2023]
Effect of Intensified Decellularization of Equine Carotid Arteries on Scaffold Biomechanics and Cytotoxicity. [2015]
Translumbar hemodialysis long-term catheters: an alternative for vascular access failure. [2020]
How arteriovenous grafts could help to optimize vascular access management. [2019]
Long-term results of autologous scaffold-free tissue-engineered vascular graft for hemodialysis access. [2022]
Implantation of completely biological engineered grafts following decellularization into the sheep femoral artery. [2021]
The effect of chronic kidney disease on tissue formation of in situ tissue-engineered vascular grafts. [2023]
Utilization of a tubularized cormatrix extracellular matrix for repair of an arteriovenous fistula aneurysm. [2015]
Sirolimus-loaded polyurethane graft for hemodialysis access in sheep. [2019]
Pulmonary arterioplasty with decellularized allogeneic patches. [2014]
11.United Statespubmed.ncbi.nlm.nih.gov
Engineering Vascularized Composite Allografts Using Natural Scaffolds: A Systematic Review. [2022]
Application of decellularized vascular matrix in small-diameter vascular grafts. [2023]
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