Decellularized Femoral Artery Transplant for Chronic Kidney Failure

(NexeonAVX Trial)

Recruiting at 3 trial locations

Overseen By Mark Archie, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: LifeNet Health

Must not be taking: Antibiotics

Disqualifiers: Severe cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Procedure day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of artery transplant, the Nexeon AVX Decellularized Femoral Artery, to evaluate its safety and effectiveness for individuals with kidney failure requiring dialysis. The goal is to determine if this artery transplant can help maintain access for dialysis treatment. Suitable candidates for this trial include those with chronic kidney failure who need dialysis to manage their condition.

As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

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.

What is the safety track record for the Nexeon AVX Decellularized Femoral Artery?

Research has shown that the Nexeon AVX Decellularized Femoral Artery is undergoing safety testing in people. Early results suggest that the treatment is generally well-tolerated. While detailed safety information remains unavailable, its inclusion in a post-market registry suggests approval for some use, indicating a certain level of safety. However, individual experiences may vary, and potential side effects could occur. Participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The Nexeon AVX Decellularized Femoral Artery is unique because it uses a decellularized artery as a graft for patients with chronic kidney failure, particularly those with end-stage renal disease. Unlike standard treatments such as synthetic grafts or native vein fistulas, this approach uses a natural vessel that has been stripped of cells, potentially reducing the risk of immune rejection and improving long-term compatibility. Researchers are excited because this innovative method could lead to better outcomes and fewer complications for patients needing vascular access for dialysis.

What evidence suggests that the Nexeon AVX Decellularized Femoral Artery is effective for chronic kidney failure?

Research has shown that the Nexeon AVX Decellularized Femoral Artery, which participants in this trial will receive, is designed to improve blood flow in patients requiring dialysis due to chronic kidney failure. The preparation process removes cells, potentially reducing the risk of rejection. Early results suggest that this artery can reliably serve as an access point for dialysis. Studies have demonstrated encouraging outcomes regarding the artery's long-term patency and function. This treatment is already in use, underscoring its effectiveness for specific blood flow issues. ^{1 2 3 4 6}

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.

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

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?

Group I: Open Label Experimental Treatment 1 Intervention

Open Label for subjects with End-Stage Renal Disease

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:

• Arteriovenous access for hemodialysis

Who Is Running the Clinical Trial?

LifeNet Health

Lead Sponsor

Trials

15

Recruited

1,200+

Published Research Related to This Trial

In a study of 108 patients using decellularized allogeneic pulmonary artery patches for cardiovascular reconstructions, there were no serious adverse events or device failures reported, indicating a strong safety profile for this new option.

Compared to a previous cohort using traditional cryopreserved patches, which had a 14% failure rate requiring reoperations, the decellularized patches showed significantly better durability and performance in the midterm follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary arterioplasty with decellularized allogeneic patches. Hopkins, RA., Lofland, GK., Marshall, J., et al.[2014]

The decellularized engineered allografts demonstrated excellent mechanical properties, with a burst pressure exceeding 4000 mmHg and compliance similar to that of natural ovine femoral arteries, indicating their potential for safe use in vascular applications.

In a sheep model, these grafts remained patent and showed no signs of dilatation or mineralization over 24 weeks, with complete endothelialization and significant recellularization, suggesting they can effectively integrate into the host tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of completely biological engineered grafts following decellularization into the sheep femoral artery. Syedain, ZH., Meier, LA., Lahti, MT., et al.[2021]

Decellularization and recellularization techniques are being explored as promising alternatives to traditional vascularized composite allotransplantation (VCA), which faces challenges like immunosuppression and donor compatibility.

The review analyzed 11 studies on decellularization protocols for various vascular composite allografts, highlighting that while sodium dodecyl sulfate is commonly used, the immunological response of these decellularized grafts is still not well understood, and successful transplantation often requires prior recellularization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engineering Vascularized Composite Allografts Using Natural Scaffolds: A Systematic Review. Lupon, E., Lellouch, AG., Acun, A., et al.[2022]

Decellularized vascular matrices offer unique advantages for small-diameter vascular grafts, including excellent biocompatibility and non-immunogenicity, making them promising alternatives for coronary artery bypass grafting (CABG).

However, challenges such as thrombosis and neoplastic endothelial hyperplasia after implantation need to be addressed to improve the long-term success of these grafts, emphasizing the importance of enhancing early endothelialization and preventing blood clots.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of decellularized vascular matrix in small-diameter vascular grafts. Li, Y., Zhou, Y., Qiao, W., et al.[2023]

In a study involving 40 rats with chronic kidney disease (CKD), a new type of vascular graft made from electrospun polycarbonate showed successful tissue formation and maintained patency rates of 100%, indicating its potential effectiveness for patients on dialysis.

Despite some increase in vascular calcification in CKD rats after 12 weeks, the grafts did not show any negative impact on mechanical stability or tissue composition, suggesting that specialized graft designs for CKD patients may not be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of chronic kidney disease on tissue formation of in situ tissue-engineered vascular grafts. Besseling, PJ., Krebber, MM., Fledderus, JO., et al.[2023]

In a pilot study involving 20 sheep, sirolimus-loaded polyurethane grafts showed improved patency rates compared to non-loaded grafts, with a 25% improvement at 3 months, suggesting potential efficacy in preventing hemoaccess occlusion in dialysis patients.

Although the results were not statistically significant, the sirolimus-coated graft consistently outperformed the control in reducing neointimal stenosis and maintaining graft patency, indicating a promising avenue for further research in drug-coated materials for hemodialysis access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sirolimus-loaded polyurethane graft for hemodialysis access in sheep. Schuman, E., Babu, J.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translumbar hemodialysis long-term catheters: an alternative for vascular access failure. Moura, F., Guedes, FL., Dantas, Y., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Intensified Decellularization of Equine Carotid Arteries on Scaffold Biomechanics and Cytotoxicity. Böer, U., Hurtado-Aguilar, LG., Klingenberg, M., et al.[2015]

The study highlights the use of a tubularized CorMatrix® extracellular matrix graft as a new method for repairing aneurysms in failing autogenous arteriovenous fistulas (AVFs), which are crucial for dialysis access.

This approach may reduce complications associated with traditional synthetic materials, such as skin breakdown and infection, thereby improving the preservation of dialysis access sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of a tubularized cormatrix extracellular matrix for repair of an arteriovenous fistula aneurysm. DuBose, JJ., Azizzadeh, A.[2015]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair. Nickerson, MC., Thamba, A., Rao, V., et al.[2023]

Arteriovenous grafts (AVG) are emerging as a promising alternative to arteriovenous fistulae (AVF) for vascular access in dialysis patients, especially for those with inadequate fistula maturation due to factors like aging and venous injury.

Recent advancements in AVG technology, including biohybrid and tissue-engineered grafts, show potential for improved biocompatibility and reduced complications compared to traditional materials, suggesting a more personalized approach to vascular access could enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How arteriovenous grafts could help to optimize vascular access management. Besarab, A., Kumbar, L.[2019]

In a study involving 10 ESRD patients, tissue-engineered vascular grafts (TEVG) showed a high primary and secondary patency rate of 86% over 12 months, indicating their effectiveness as a dialysis access option.

The use of TEVG significantly reduced the dialysis event rate from 3.34 to 0.67 events per patient-year, suggesting improved functionality and reduced complications compared to traditional synthetic grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term results of autologous scaffold-free tissue-engineered vascular graft for hemodialysis access. Wystrychowski, W., Garrido, SA., Marini, A., et al.[2022]

Citations

1. yalemedicine.org yalemedicine.org/clinical-trials/nexeon-avx-decellularized-femoral-artery

Nexeon™ AVX Decellularized Femoral Artery The purpose of this study is to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon™ AVX ...

2. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/nexeon-avx-decellularized-femoral-artery/

Nexeon™ AVX Decellularized Femoral Artery The purpose of this study is to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon™ AVX ...

3. withpower.com withpower.com/trial/early-phase-1-kidney-diseases-4-2023-32319

Decellularized Femoral Artery Transplant for Chronic Kidney ... 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 ...

4. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/trial/NCT05880537

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

5. lifenethealth.org lifenethealth.org/Nexeon-Decellularized_Femoral_Artery

Nexeon® Decellularized Femoral Artery Nexeon is a decellularized vascular allograft intended for use as a conduit for blood flow in the peripheral vasculature. Long-term Patency*: Matracell® ...

6. ucla.clinicaltrials.researcherprofiles.org ucla.clinicaltrials.researcherprofiles.org/chronic-kidney-disease

UCLA Chronic Kidney Disease Clinical Trials — Los Angeles The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) ...