Gunze provides biodegradable scaffolds for TEVG clinical trial to be conducted at the Abigail Wexner Research Institute at Nationwide Children’s Hospital to improve pediatric patient clinical outcome

September 24, 2020

Figure: Biodegradable scaffold

Gunze is pleased to announce that Gunze’s biodegradable scaffolds are being provided to the Abigail Wexner Research Institute at Nationwide Children's Hospital (Location: Columbus, OH, USA) to conduct its first human tissue engineered vascular grafts (hereinafter TEVG), clinical trial.

1. Background

The synthetic grafts that are currently available have contributed to improved outcomes for pediatric patients’ cardiovascular surgery (i.e., congenital heart disease likes single ventricular disease). However, because the synthetic grafts do not grow alongside the living body parts, it can be necessary to perform additional surgeries in order to replace the grafts. This is a heavy burden on the patients. Additionally, the implementation of these graft materials at small diameters has demonstrated poor patency, inhibiting their use for coronary artery bypass surgery in adults. When applied to a pediatric patient population, they are handicapped by their inability to grow alongside the patient. Tissue engineered alternatives could possibly address these limitations by producing biocompatible implants with the ability to repair, remodel, grow, and regenerate. A tissue engineered vascular graft (TEVG) generally consists of a biodegradable scaffold, seeded cells, and the appropriate environmental cues (i.e., growth factors, physical stimulation) to induce tissue formation. To solve the problem, Toshiharu Shinoka, MD, PhD, co-director of the Tissue Engineering Program, and Christopher Breuer, MD, director of the Center for Regenerative Medicine, both of Nationwide Children’s, have developed the TEVG technology with Gunze’s biodegradable scaffold and will commence use of the Gunze scaffold in the first clinical trial using this material. However, it is difficult to work on a commercial basis to supply biodegradable scaffolds for such a rare disease like single ventricular disease. Gunze management has defined “QOL improvement” as a key challenge to resolve and has engaged with Nationwide Children’s to sponsor a clinical trial. Nationwide Children’s received clinical trial approval from the US FDA in August 2019.

2. About the biodegradable scaffolds

The biodegradable scaffolds are generated by our “bioabsorbable materials” and “fiber/polymer processing technology”. Cells taken from the bone marrow of the patient are seeded on this to form an artificial blood vessel. This is implanted as a cardiovascular bypass, and, after about 6 months, this revascularization base material is absorbed and regenerated as blood vessels using the patient's own tissue. By using organic material from the child’s own body, surgeons can avoid the problems associated with synthetic grafts and implantations.Previous studies have confirmed that this regenerated vessel follows the growth of the patient. As a result, subsequent surgery is avoided and restrictions on daily life are reduced, leading to improved patient QOL. Dr. Shinoka is one of the inventors of Gunze’s biodegradable scaffold.

3. Marketing Strategy

Gunze will establish and confirm safety and efficacy of biodegradable scaffolds in clinical trials in the U. S. and strive to build a sales system. In addition, by taking advantage of Gunze’s strengths in “bioabsorbable materials” and “fiber/polymer processing technology,” the patients’ QOL will continue to improve through the development and advocacy of less-invasive medical devices and procedures.

Please refer to the original press release here: