What is the IDCT trial?
DiscGenics is conducting a Phase I/II prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical study in the U.S. among subjects with single-level, symptomatic lumbar degenerative disc disease (DDD).
Why is this clinical research study being conducted?
The purpose of this research is to evaluate the safety and preliminary efficacy of IDCT, a new investigational cell-based treatment for DDD.
Will being in the study help me?
The study is being done to see if IDCT, the investigational product, is safe and effective in reducing low back pain. IDCT may help your DDD, but there is no guarantee that being in this study will help you. Information gathered in this study may inform development of new tests and/or treatments to help others in the future.
Is the IDCT trial FDA approved?
Yes, the U.S. Food and Drug Administration (FDA) has allowed DiscGenics, the developer of IDCT and sponsor of the trial, to proceed with the study through an investigational new drug (IND) application.
Is there an IDCT trial site near me?
Spine centers and pain clinics in cities across the U.S. are currently recruiting patients for participation in the trial, including:
Los Angeles, CA
San Diego, CA
Santa Monica, CA
New York, NY
What will be required of me if I qualify and choose to participate in the IDCT trial?
As a participant, you will receive a consent form that thoroughly explains all of the details of the study. You will be asked to:
Take part in a screening process to determine if you are eligible to participate in the study. This period can take up to 30 days; however, all screening tests and procedures will be completed in a single office visit.
Receive a one-time injection of your assigned treatment into the painful disc.
Attend a total of eight (8) follow-up visits over approximately two (2) years.
Will I be compensated for participating in the trial?
Compensation for participation in this study is determined on a site-by-site basis and may include a small stipend and/or reimbursement for travel.
What will it cost me to participate in the IDCT trial?
There are no study-related costs for subjects who participate in the IDCT trial.
For more information about our U.S. clinical trial for DDD, including complete enrollment criteria and a list of participating sites, please visit clinicaltrials.gov.