Tissue Engineered Vascular Grafts for Heart Disease

(TEVG-2 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Mark Galantowicz, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Nationwide Children's Hospital

Must not be taking: Bisphosphonates

Disqualifiers: Acute renal failure, Pacemaker, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.

Will I have to stop taking my current medications?

The trial may require you to stop taking certain medications if they could interfere with the study, such as bisphosphonates (medications that prevent bone loss). It's best to discuss your current medications with the trial investigator to see if any changes are needed.

What data supports the effectiveness of the treatment Second-Generation Tissue Engineered Vascular Grafts for heart disease?

Research shows that tissue-engineered vascular grafts (TEVGs) can transform into vessels that function like natural ones and have the ability to grow, which is promising for heart surgeries in children. Although there are challenges like blood clots and vessel thickening, studies in both animals and humans have shown encouraging results, suggesting TEVGs could eventually replace traditional grafts.

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Is the use of tissue-engineered vascular grafts safe in humans?

Tissue-engineered vascular grafts (TEVGs) have shown an excellent safety profile in clinical trials, although about 16% of grafts may experience stenosis (narrowing) within the first seven years after implantation.

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How is the Second-Generation Tissue Engineered Vascular Grafts treatment different from other treatments for heart disease?

Second-Generation Tissue Engineered Vascular Grafts (TEVGs) are unique because they are made from biologically active cells and biodegradable scaffolds, allowing them to grow and repair themselves, unlike traditional synthetic grafts that cannot remodel or self-repair. This makes TEVGs potentially more effective, especially for smaller diameter grafts, as they can adapt and integrate better with the body's natural tissues.

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Eligibility Criteria

This trial is for children with certain heart defects who need a special surgery called extracardiac total cavopulmonary connection. They must be able to follow the study plan and not have urgent medical issues, pacemakers, severe heart valve problems, other serious health conditions, or need graft sizes outside of 12-24 mm. Kids with high lung blood pressure or abnormal veins can't join.

Inclusion Criteria

Patient and/or legal guardian must voluntarily provide informed consent/assent for participation in the study.

I am eligible for a specific heart surgery to improve blood flow.

Exclusion Criteria

Patient has a history of another condition or significant medical problem that, in the opinion of the investigator, precludes compliance with protocol-specified procedures.

Patient or parent/legal guardian is, in the opinion of the investigator, unable to comply with protocol evaluations.

You need a graft that is not between 12 and 24 millimeters in diameter.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients with single ventricle cardiac anomalies undergo EC TCPC using a tissue engineered conduit

Immediate post-operative period

In-patient surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and graft performance

2 years

Regular follow-up visits at Nationwide Children's Hospital

Interim Analysis

Interim analysis to assess early graft-related complications in the first 6 enrolled patients

Up to 6 months

Participant Groups

The study tests second-generation tissue engineered vascular grafts (TEVG) in kids needing heart surgery to connect large veins to their lungs. It's checking if these new grafts are safe and work well over two years without using different treatment groups.

Group I: Tissue Engineered Vascular Grafts Experimental Treatment 1 Intervention

Second-Generation Tissue Engineered Vascular Grafts is already approved in United States for the following indications:

🇺🇸 Approved in United States as Second-Generation TEVG for:

• Extracardiac Total Cavopulmonary Connection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Nationwide Children's Hospital Columbus, OH

Who Is Running the Clinical Trial?

Nationwide Children's Hospital Lead Sponsor

National Institutes of Health (NIH) Collaborator

National Heart, Lung, and Blood Institute (NHLBI) Collaborator

Gunze Limited Collaborator

References

1. United States pubmed.ncbi.nlm.nih.gov

Late-term results of tissue-engineered vascular grafts in humans. [2022] The development of a tissue-engineered vascular graft with the ability to grow and remodel holds promise for advancing cardiac surgery. In 2001, we began a human trial evaluating these grafts in patients with single ventricle physiology. We report the late clinical and radiologic surveillance of a patient cohort that underwent implantation of tissue-engineered vascular grafts as extracardiac cavopulmonary conduits.

2. England pubmed.ncbi.nlm.nih.gov

Stem cells for tissue engineered vascular bypass grafts. [2018] Despite great advances in tissue engineering, there have been very few reports on the successful clinical use of small-diameter tissue-engineered vascular grafts (TEVGs). Small-diameter (

3. England pubmed.ncbi.nlm.nih.gov

Tissue engineered vascular grafts transform into autologous neovessels capable of native function and growth. [2023] Tissue-engineered vascular grafts (TEVGs) have the potential to advance the surgical management of infants and children requiring congenital heart surgery by creating functional vascular conduits with growth capacity.

4. China pubmed.ncbi.nlm.nih.gov

Selection of different endothelialization modes and different seed cells for tissue-engineered vascular graft. [2021] Tissue-engineered vascular grafts (TEVGs) have enormous potential for vascular replacement therapy. However, thrombosis and intimal hyperplasia are important problems associated with TEVGs especially small diameter TEVGs (

5. United States pubmed.ncbi.nlm.nih.gov

The Current Status of Tissue-Engineered Vascular Grafts. [2015] Tissue-engineered vascular grafts (TEVGs) are currently being developed to overcome the limitations and complications associated with traditional synthetic grafts. This article aims to review the current status of research into the production and use of tissue-engineered grafts. TEVGs have a number of theoretical advantages over synthetic grafts. The results of animal and human studies have been promising, but more work must be done before TEVGs can replace traditional grafts.

6. England pubmed.ncbi.nlm.nih.gov

Tissue engineered vascular grafts: current state of the field. [2018] Conventional synthetic vascular grafts are limited by the inability to remodel, as well as issues of patency at smaller diameters. Tissue-engineered vascular grafts (TEVGs), constructed from biologically active cells and biodegradable scaffolds have the potential to overcome these limitations, and provide growth capacity and self-repair. Areas covered: This article outlines the TEVG design, biodegradable scaffolds, TEVG fabrication methods, cell seeding, drug delivery, strategies to reduce wait times, clinical trials, as well as a 5-year view with expert commentary. Expert commentary: TEVG technology has progressed significantly with advances in scaffold material and design, graft design, cell seeding and drug delivery. Strategies have been put in place to reduce wait times and improve 'off-the-shelf' capability of TEVGs. More recently, clinical trials have been conducted to investigate the clinical applications of TEVGs.

7. Netherlands pubmed.ncbi.nlm.nih.gov

Vascular tissue engineering: towards the next generation vascular grafts. [2011] The application of tissue engineering technology to cardiovascular surgery holds great promise for improving outcomes in patients with cardiovascular diseases. Currently used synthetic vascular grafts have several limitations including thrombogenicity, increased risk of infection, and lack of growth potential. We have completed the first clinical trial evaluating the feasibility of using tissue engineered vascular grafts (TEVG) created by seeding autologous bone marrow-derived mononuclear cells (BM-MNC) onto biodegradable tubular scaffolds. Despite an excellent safety profile, data from the clinical trial suggest that the primary graft related complication of the TEVG is stenosis, affecting approximately 16% of grafts within the first seven years after implantation. Continued investigation into the cellular and molecular mechanisms underlying vascular neotissue formation will improve our basic understanding and provide insights that will enable the rationale design of second generation TEVG.