Harvard Apparatus Regenerative Technology, Inc. (HRGN) has announced a strategic collaboration with the Capital Institute of Pediatrics in Beijing, China, to develop innovative treatments for Esophageal Atresia (EA). The partnership will focus on clinical research, product development, and expanding patient access to life-saving treatments using HRGN’s Cellspan Esophageal Implant (CEI).
Collaboration Aims to Transform EA Treatment
The collaboration aims to leverage HRGN’s pioneering platform technology with the Capital Institute of Pediatrics’ expertise in pediatric care. Dr. Lishuang Ma, a chief surgeon at the Children’s hospital Capital Institute of Pediatrics, expressed enthusiasm about the collaboration, stating it offers an exciting opportunity to leverage cutting-edge regenerative medicine technology in addressing Esophageal Atresia, a condition that requires innovative solutions. The goal is to improve patient outcomes and bring hope to families affected by this challenging condition.
Clinical Trials and Regulatory Pathway
The partnership will focus on conducting Investigator Initiated Trials (IITs) to evaluate the safety and efficacy of the CEI product in treating Esophageal Atresia. The aim is to accelerate regulatory approval and expand access to this novel treatment. Jerry He, HRGN’s Chief Executive Officer, Director and Chairman, shared that their CEI product holds tremendous potential to improve the quality of life for children with Esophageal Atresia, and this partnership accelerates their ability to bring this innovation to those who need it most.
About Esophageal Atresia
Esophageal Atresia is a rare congenital condition in which the esophagus does not form properly. This can lead to significant challenges for newborns, including difficulty feeding and breathing. Current treatments often involve surgery to connect the esophagus, but complications can arise, highlighting the need for innovative solutions like the CEI.
HRGN's Regenerative Technology
HRGN is a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and other organs resulting from cancer, trauma, or birth defects. Their technology is based on a proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. The company believes this technology represents a next-generation solution for restoring organ function, eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs, or permanent artificial implants.
Prior Successes
HRGN conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. The surgery was performed by Dr. Dennis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results, published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021, demonstrated that the technology could successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity, and functionality of the esophageal tube.
