ImageIQ Selected to Partner with Histogenics in Clinical Trial
Regenerative medicine company Histogenics has selected ImageIQ, a contract research organization founded by the Cleveland Clinic, to provide imaging analytics for the Phase 3 investigational new drug (IND) clinical trial of the Histogenic’s NeoCart implant. NeoCart is an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the regeneration of cartilage lesions. The product recently entered the Phase 3 IND clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met, and NeoCart was found to be generally well tolerated.
The contract has the two companies partnering for several years, with ImageIQ providing all imaging components of the trial including site training, site compliance and image management. ImageIQ is developing protocols and ensuring protocol standardization across several sites, each using various types of magnetic resonance imaging scanners to acquire images. ImageIQ will aggregate and report on imaging data at specific time points and, at trial conclusion, will assist in developing the imaging portion of Histogenics’ U.S. Food and Drug Administration (FDA) submission and serve as imaging experts when Histogenics presents the results of their trials to the FDA.
“The imaging component of this clinical trial requires an intense focus on data accuracy and smooth workflow,” says Patrick O’Donnell, Histogenics’ president and CEO. “ImageIQ brings a solid reputation of excellence in imaging analysis to the challenge of the difficult problem of imaging cartilage. We are happy to have ImageIQ as a partner during this important time in the development of NeoCart.”
ImageIQ is based in Cleveland, Ohio, and the company provides combines software engineering with biomedical and imaging expertise to provide quantitative visual analysis designed to enhance research & development and product efficacy/safety testing for research, medical device and pharmaceutical organizations.
“We are excited to apply our deep-seated experience in orthopedic imaging analysis to the Histogenics NeoCart trial,” says Tim Kulbago, ImageIQ CEO. “We look forward to supporting the exceptional work of the Histogenics team as they work to bring their NeoCart product to market in the fast-growing and exciting area of regenerative medicine.”
Based in Waltham, Mass., Histogenics combines cell therapy and tissue engineering technologies to develop products for tissue repair and regeneration.