【Youth Daily】 T&R Biofab obtained approval from the Ministry of Food and Drug Safety for its clinical trial plan (IND) for’T&R Velapore-E’, a patient-specific biodegradable artificial scaffold for ear reconstruction for lateral microtia patients. It was revealed on the 29th.
Accordingly, T&R Biofab plans to conduct a researcher-led exploratory clinical trial of the artificial scaffold with Professor Yoon In-sik’s team at Gangnam Severance Hospital’s plastic surgery department.
Microtia is a disease in which one or both ears are congenital much smaller than normal and deformed in shape. It occurs at the level of 1 in 6,000 children, and lateral microtia in which one of the two ears is undergrown is common.
Conventionally, for the treatment of microtia, a surgical method in which the patient’s own chest cartilage or non-absorbable material is used in the ear was mainly used. However, these surgical methods have been pointed out in terms of clinical limitations, such as the burden of extracting the patient’s chest cartilage and the problem of inflammatory reaction caused by existing non-absorbable materials.
T&R Biofab’s artificial scaffold for patient-specific ear reconstruction is designed and manufactured in the same way as the normal ear of microearly ear patients with its own 3D bioprinting technology.In particular, the artificial scaffold is slowly decomposed after implantation using biodegradable (bioabsorbable) materials The advantage is that it is replaced by the patient’s own tissue. When the clinical development is completed, it is expected that it can be used more effectively in pediatric microtia patients compared to existing surgical methods.
T&R Biofab and Gangnam Severance Hospital will conduct research to re-evaluate conventional surgical methods through researcher-led clinical trials for adult patients with lateral microtia and confirm the effectiveness and safety of biodegradable artificial scaffolds for patient-specific ear reconstruction. Plan.
The researchers at T&R Biofab said, “This IND approval is a meaningful achievement after three years of close discussion with the Ministry of Food and Drug Safety. Through the first clinical trial in Korea of a biodegradable artificial scaffold for patient-specific ear reconstruction, the lives of patients with lateral microtia We will provide an opportunity to develop new treatments that can contribute to improving the quality of our health.”
He added, “Especially, it is expected that effective treatment will open up to pediatric patients who have had difficulty with surgery.”
【Youth Daily = Reporter Ahn Sang-jun】