CTI Clinical Trial and Consulting Services (CTI) announces its collaboration with DiscGenics, a regenerative medicine company focused on developing cell therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, on the execution of a first-in-human trial of IDCT for degenerative disc disease (DDD).
DDD is a chronic and progressive disease that is characterized by a breakdown of tissue within the intervertebral disc and contributes to chronic low back pain in millions of patients. IDCT is a non-invasive therapy comprised of allogeneic progenitor cells known as Discogenic Cells, which have been derived from donor intervertebral disc tissue, and a viscous delivery vehicle. Preclinical studies of IDCT have demonstrated its potential to normalize the tissue architecture and restore the height of the degenerated disc.
DiscGenics’ Phase I/II prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical study, which CTI is managing with DiscGenics, is being conducted to evaluate the safety and preliminary efficacy of IDCT in subjects with single-level, symptomatic lumbar intervertebral disc degeneration. The 60-subject trial will take place in up to 10 centers across the United States.
“CTI’s experience in developing allogeneic cell therapy products, and their understanding of the potential regulatory and clinical challenges presented by these types of advanced therapies, makes them an excellent partner for DiscGenics as we commence our first-in-human clinical trial of IDCT for DDD,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. “We are looking forward to working closely with the team at CTI to flawlessly execute this trial, which we hope will generate the necessary data to continue to advance our clinical program, and ultimately bring us one step closer to delivering on our vision of transforming the way millions of patients suffering from the debilitating effects of chronic back pain are treated.”
CTI, an expert in regenerative medicine and in the development of life-changing therapies in critically ill patients, has been a part of several dozen First-In-Human trials over the past few years.
“We’re excited to be partnering with DiscGenics on this innovative trial in the growing field of regenerative medicine,” said Lynn Fallon, President at CTI. “This program has the potential to positively impact many patients with degenerative disc disease and is an excellent opportunity for CTI to partner with an exciting company like DiscGenics. This project also expands our work in cell therapy, which currently represents approximately 40% of CTI’s active research programs.”
About DiscGenics
DiscGenics is a privately held, clinical stage regenerative medicine company focused on developing cell therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics is harnessing the restorative potential of cells native to the intervertebral disc to develop what we hope will be a profound therapeutic option for millions of patients suffering from the debilitating effects of back pain. DiscGenics’ first product candidate, IDCT, is a homologous, allogeneic, injectable cell therapy for the treatment of patients with mild to moderate degenerative disc disease.
About CTI Clinical Trial and Consulting Services
CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hematology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit www.ctifacts.com