CRO giant IQVIA has signed on to conduct the first clinical trial of Biostage’s lab-grown esophageal implant.
The FDA-approved open-label trial is designed to assess safety and efficacy in up to 10 patients who require removal of up to six centimeters of their esophagus due to cancer, trauma or birth defect, the company said in a Dec. 28 press release. The trial will be conducted at up to five hospitals in the U.S. with the primary endpoint being the establishment of a continuous biological conduit at three months following the implant procedure.
The process uses a biocompatible scaffold seeded with a patient’s own cells to build an individualized, regenerative implant. If successful, the implant could replace the practice of using parts of the stomach or intestine to create a mock esophagus.
Biostage’s implant was first used in a human cancer patient at the Mayo Clinic under the FDA’s compassionate use protocol and achieved its one-month endpoint, with the results published in August 2021.
"We are pleased to collaborate with Biostage in its first clinical trial, to bring this important treatment to patients in need,” Wendy Stewart, IQVIA’s president of clinical operations, said in the release.
IQVIA will work with AmerisourceBergen's World Courier, a global specialty logistics provider, to ensure tissue samples and engineered implants are “handled with the care they deserve,” she said.
The protocol will involve a staggered enrollment and two years of follow up for each patient. Biostage said it expects to take between four and six years to complete the trial.