DiscGenics Joins MedCision's ThawSTAR Early Adopter Program for Cell Therapy Clinical Trials
Regenerative Medicine Company to Adopt ThawSTAR® Cell Thawing Systems for First-in-Human Clinical Trial in Degenerative Disc Disease
SAN RAFAEL, Calif. & SALT LAKE CITY--(BUSINESS WIRE)-- MedCision, the world leader in next-generation automated cell thawing for advanced therapies, and DiscGenics, a regenerative medicine company focused on developing cell therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that DiscGenics has joined MedCision’s ThawSTAR Clinical Early Adopter Program. The program was initiated to help companies and investigators de-risk thawing of frozen cell therapies in early stage clinical trials through to commercialization and point-of-care.
DiscGenics’ therapeutic candidate, IDCT, addresses degenerative disc disease (DDD), a painful, chronic and progressive disorder caused by the breakdown of disc tissue that separates the vertebra of the spine. To ensure optimal clinical outcomes, the ThawSTAR CFT2 System has been programmed with a customized algorithm specific to IDCT’s unique characteristics. It accounts for the effect that cell size, volume, and the Company’s choice of cryopreservative all have on the thawing rate needed to preserve optimal function of the cell-based therapy.
“Standardizing and automating processes to produce repeatable results is a paramount concern in designing clinical trials for cell therapies,” said Samuel Kent, Chief Commercial Officer of MedCision. “ThawSTAR is a unique controlled and automated cell thawing system that reduces cell handling risk while eliminating variability. By replacing detrimental water baths with a standardized and automated system, our users can benefit from a scalable and customizable solution for their cell therapy products from the outset.”
“We are delighted that our U.S. clinical trial of IDCT for mild-to-moderate DDD will include the use of MedCision’s ThawSTAR System,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. “Because IDCT is cryopreserved for off-the-shelf use, it is imperative that we have a thawing process that has been de-risked and optimized from the start of our trial. We are confident that MedCision’s automated thawing technology will allow us to eliminate obsolete technologies and offer our trial investigators a seamless cell handling process.”
For free training or questions about the use of ThawSTAR® platform, including the Clinical Early Adopter Program, please contact Samuel Kent at email@example.com. Videos about ThawSTAR can be found here.
MedCision is the world leader in next-generation automated cell thawing for advanced therapies. The company develops and commercializes technologies that automate and standardize the clinical handling and processing of biologics. MedCision's digitally enabled ThawSTAR® Automated Cell Thawing Systems are designed to replace uncontrolled and highly variable manual methods, de-risking the therapeutic cell thawing process and optimizing cell efficacy. An industry first, ThawSTAR systems optimize cell thawing using a customizable algorithm for each unique cell therapy product and protocol. These systems, combined with MedCision’s ultra-low temperature cold storage and transport solutions, advance near-patient drug management by providing controlled and scalable processing of temperature-sensitive biotherapeutic products. For more information please visit www.medcision.com or www.medcision.com/blog/.
DiscGenics is a privately held, clinical stage regenerative medicine company focused on developing regenerative 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 that utilizes proprietary Discogenic Cells to offer a non-surgical, potentially regenerative solution for the treatment of patients with mild to moderate degenerative disc disease.
Source: MedCision, LLC