IQVIA will run a trial of a candidate lab grown esophagus implant being developed by US regenerative medicines firm Biostage.
The implant – which was previously known as Cellspan Esophageal Implant -is designed to treat people who require surgical resection of the esophagus as a result of cancer, trauma, or birth defects.
Each implant consists of a scaffold on which cells harvested from the specific patient are grown.
Biostage CEO David Green said, “we are very pleased to be partnering with IQVIA to perform the clinical trials needed to bring our Biostage Esophageal Implant product candidate to the patients who need it.”
The study will recruit ten patients who require the removal of up to 6cm of their esophagus at five hospitals in the US. The primary endpoint is the establishment of a “continuous biological conduit” at three months post implantation.
The contract with IQVIA covers first stage of work to prepare for the trial. Biostage said it anticipates entering into a second more comprehensive contract with IQVIA that will cover the remaining aspects of the trial in due course.
The trial protocol requires a staggered enrolment and two years of follow up for each patient, meaning the complete program will take between four and six years.
Wendy Stewart, president of clinical operations for IQVIA, welcomed the contract, explaining "advancing healthcare is a top priority for IQVIA and we are pleased to collaborate with Biostage in its first clinical trial, to bring this important treatment to patients in need.”
She added IQVIA will work with AmerisourceBergen's World Courier to “ensure these tissue samples and engineered implants are handled with the care they deserve."
News of the contract comes just weeks after Biostage published data from an animal study which suggested the implant induced early tissue growth and regeneration in nine pigs with full circumferential esophageal segmental replacement.