The SMART Clinic in Utah is the research site of an innovative new regenerative, stem-cell-based therapy to alleviate pain and restore functions in patients with degenerative diseases of the spine. It was announced that the first Utah residents were treated in a nationwide study of ICDT, a locally developed injectable disc cell therapy for degenerative disc disease (DDD).
A fascinating study that if works will be a major breakthrough for the millions that struggle with disc-related back pain for example. We cannot ignore that many with disc problems have also made their way to pain clinics that focus on steroid injections and pain management with opiates that often lead to dire addiction-based health issues.
The Sponsor & Investigational Treatment
DiscGenics, Inc. a clinical-stage biotechnology company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. Based in Salt Lake City, Utah, they have raised over $20 million in venture capital financing and have been around since 2007.
DiscGenics began development of IDCT at its laboratories in the dynamic University of Utah Research Park, adjacent to the mountains and overlooking beautiful Salt Lake City, Utah. It has since moved into a new research and development center near the Northwest tech quadrant as recently announced by the Salt Lake City Department of Economic Development.
What is IDCT?
IDCT is the first product candidate to utilize the Discogenic Cell platform. IDCT is an allogeneic (donor-derived), non-invasive cell therapy that is being evaluated in Phase I/II clinical trial for the treatment of patients with mild to moderate lumbar degenerative disc disease (DDD). During treatment, a single dose of IDCT is injected into the painful disc percutaneously (non-surgically).
Based on preclinical experience with IDCT, the company’s leadership hypothesize that the result will be reduced pain and disability caused by inflammation within the diseased disc.
IDCT Born in Utah
DiscGenics Inc. CEO and Chairman of the Board Flagg Flanagan declared “Utah has a great pool of STEM-trained professionals and we’ve built an increasable team that leverages the expertise of local talent to support our preclinical and clinical development.
He continued “Developing the IDCT has been a true labor of love for the team here in Salt Lake and we are so pleased to be bringing it back home where we have the potential to not only make a significant impact on the health and wellness of our neighbors suffering from chronic low back pain but to also play a small role in combatting the opioid crisis in our own backyard.”
The Clinical Investigative Site & Study
The patients were treated at The SMART Clinic in Draper Utah. The study there is being managed by Physicians’ Research Options, LLC (PRO®), a Clinical Research Company that is one of 13 clinical sites across the United States participating in the U.S. Food and Drug Administration-approved trial. The clinical study, which passed its initial planned safety review earlier in the year, is designed to evaluate the safety and preliminary efficacy of IDCT, a homologous and allogeneic cell therapy, in the treatment of mild to moderate DDD.
Who is Physicians’ Research Options?
Based in Salt Lake City metro, Utah Physicians’ Research Options are an experienced Clinical Research Company dedicated to the performance of Phase I-IV pharmaceutical and pilot/pivotal medical device clinical trials. They report that their staff experience totals over 60 years in clinical and medical research. Their staff recruits for and manages studies including paid clinical trials, in 10 investigative clinics, in Utah, Nevada, and Colorado.
PRO has a mature network of Clinical Investigators who conduct clinical trials. Their investigators are dedicated and motivated to provide the highest level of patient care and quality study data. Their staff brings experience such as regulatory, contract/budget, research coordination, etc. They are managing the IDCT study.
What is DDD?
DDD is a chronic, progressive and painful condition that affects approximately one-quarter of adults in the U.S. at a given time. In the earlier stages of DDD, current treatment options are limited to physical rehabilitation and pain management approaches, such as opioid use, that are typically not intended for long-term use.
In fact, as we alluded to earlier, individuals suffering from chronic low back pain, such as DDD, account for nearly 60% of prescription opioid usage in the U.S. Prescription opioids are also the main driver of overdose deaths involving opioids in Utah, accounting for nearly 70% of the 456 opioid deaths in the state in 2017. IDCT could be a vital tool to help curtain opioid addiction among those suffering from this debilitating condition.
Principal Investigator Comments
Angela Krull, MD of the SMART Clinic noted: “We’re thrilled to be participating in the clinical evaluation of IDCT.” She continued “The SMART Clinic is committed to changing the way spine conditions are managed in Salt Lake City and throughout Utah, and we believe that this potentially regenerative, non-surgical therapeutic option could have a significant impact on our patients with DDD.”
Angela Krull, MD, the SMART Clinic