What is the IDCT trial?
DiscGenics is conducting a Phase III prospective, randomized, double-blinded, sham-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 study is to find out if the experimental drug, Injectable Disc Cell Therapy (IDCT), is safe and effective in treating your symptomatic lumbar degenerative disc disease. IDCT is an experimental (investigational) treatment because it has not been approved by the US Food and Drug Administration (FDA) for this use.
Will being in the study help me?
If you are randomized to receive the IDCT treatment and it is effective in treating your degenerative disc disease, it is expected that you will experience a reduction in your back pain and an increase in mobility. You may be able to go longer without any treatment for your back pain or reduce the pain medications you are currently taking. You could also experience an increase in your quality of life, improvements in your mental health and social intimacy, and an easier time performing daily life tasks and social activities that were once more difficult due to pain and/or lack of mobility. Additional benefits include medical supervision and monitoring which could have a benefit to your overall health regardless of treatment assignment.
There is also a chance you may not receive any medical benefit (such as decreased pain, increased mobility, increased general well-being) from being in this study. Even if you receive no benefit at all, your participation in the study will help your study doctor and others who treat people with Symptomatic Lumbar Intervertebral Disc Degeneration to learn more about this condition and may lead to better treatments 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?
Approximately 30-35 spine centers and pain clinics in cities across the U.S. will participate in the trial. The most current list of clinical sites is on clinicaltrials.gov and will be updated as sites are added.
Am I guaranteed to receive the IDCT treatment?
Each participant in the study will be assigned on a random basis (like drawing a number from a hat) to one of two treatment groups to receive either IDCT treatment or sham (a placebo that is only a needle stick with nothing injected). You will have a 2 to 1 chance (or 66% chance) of being assigned to the IDCT treatment group. This is a blinded study which means you and the study doctor that you will have follow up appointments with throughout the study cannot choose your study group and will not know what group you were randomized to until the end of the study when it is unblinded. Only the doctor doing the injection and the staff helping with the procedure will know.
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 45 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 (IDCT group) or needle insertion into the skin in the area of your affected disc, but not into your disc and nothing will be injected (sham group).
Attend a total of eight (8) follow-up visits and two (2) follow-up phone calls over approximately two (2) years.
Fill out questionnaires on an app on your phone prior to follow-up visits about your pain and general health/well being.
Will I be compensated for participating in the trial?
Compensation for participation in the trial 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.