IDCT Back Pain Clinical Trial for Degenerative Disc Disease – Enrolling Now
Dr. John Peloza is an investigator in a U.S. clinical research study evaluating an investigational, non-surgical treatment called Injectable Disc Cell Therapy (IDCT) for people with chronic low back pain caused by degenerative disc disease.
If you have ongoing low back pain and are interested in research-based treatment options, you can learn more here or through the study sponsor’s website.
Do You Have Chronic Low Back Pain?
Spine centers and pain clinics across the U.S. are currently accepting participants in a clinical research study of a new non-surgical study treatment, known as IDCT, for degenerative disc disease (DDD) of the lower spine.
The study is evaluating IDCT, an investigational cell-based therapy for DDD that aims to reduce pain and disability.
If you have experienced chronic low back pain for at least six months, you may qualify.
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.
What is degenerative disc disease?
Degenerative disc disease (DDD) is a chronic and progressive condition that occurs when the soft tissue (intervertebral disc) that acts as a cushion between two bones of your spine start to breakdown. This often happens when we get older due to wear and tear over time, but sometimes can happen because of an injury.
When the discs start to wear out, this can cause pain, and inflammation in the joints and sometimes affects our ability to do certain things. Pain is most commonly felt or made worse by movements such as sitting, bending, lifting or twisting.
What is the intervertebral disc?
The intervertebral disc is located between the vertebral bones in the spine and acts like a pillow to cushion and evenly distribute pressure across the vertebrae. Each disc is comprised of an outer fibrous ring, the annulus fibrosis, which surrounds an inner gel-like center, called the nucleus pulposus.
How is degenerative disc disease diagnosed?
To help determine if you have degenerative disc disease, a physician will assess your medical history, conduct a physical exam and, in many cases, order diagnostic imaging, such as an x-ray, CT scan or MRI scan.
How is degenerative disc disease currently treated?
In the earlier stages of DDD, current treatment options include physical rehabilitation programs and pain management approaches that are typically not intended for long-term use. Opioids, epidural steroid injections and radiofrequency ablation are a few examples of these.
In the more advanced stages, surgical intervention may be required to remove the patient’s painful disc(s), fuse two or more vertebral bones together, and/or replace bone or tissue altogether.
While these options may offer temporary pain relief, they do not directly address the root cause of the pain: the degenerated disc.
About IDCT Treatment
What is IDCT?
IDCT is an investigational injectable disc cell therapy that utilizes proprietary Discogenic Cells to offer an off-the-shelf, non-surgical treatment for mild to moderate degenerative disc disease.
What are Discogenic Cells?
Discogenic Cells are therapeutic cells that have been specially grown from donated adult human intervertebral disc tissue to treat the complex environment of the degenerated disc.
Discogenic Cells are grown in a highly regulated manufacturing facility and subjected to extensive testing, including identity, purity, potency and safety evaluations prior to use.
How is IDCT administered?
During study treatment, a single dose of IDCT is injected into the painful disc percutaneously (non-surgically).
How does IDCT work?
The Phase I/II Clinical Study of IDCT, published in 2024, showed evidence of reduced pain and disability. Discogenic Cells are believed to possess the key regenerative and anti-inflammatory properties of mesenchymal stem cells (MSCs) as well as the ability to normalize disc architecture, regenerate new disc tissue and restore disc height when injected into a degenerated disc.
Learn more about the previous IDCT clinical study.
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.
Potential Benefits and Limitations
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.
Eligibility and Pre-Screening
Do I qualify for participation in the IDCT trial?
If you have been diagnosed with or believe you have degenerative disc disease in your lower back, you may be interested in the IDCT trial.
How do I get pre-screened for the IDCT trial?
Click here to take an online pre-screening questionnaire.
The questionnaire will help determine if you meet the key inclusion criteria for the IDCT trial. However, please note that completing the questionnaire does NOT obligate you to participate in the study and only your local study site can determine whether or not you may be eligible to join.
If I qualify, what are the next steps?
If your responses meet the preliminary criteria for the study, you’ll have the option to share your contact information with DiscGenics. If there’s an IDCT trial site in your area, DiscGenics will pass your information to that site, and the site will contact you when recruitment begins.
What are some reasons I may not qualify for the IDCT trial?
Prior to beginning the IDCT trial, DiscGenics worked closely with the U.S. Food and Drug Administration (FDA) to define a set list of enrollment criteria that would enable us to most effectively and efficiently evaluate the safety and preliminary efficacy of IDCT for the treatment of degenerative disc disease. This requires us to follow very specific screening guidelines to ensure that the subjects enrolled in our study meet the criteria we agreed upon with the FDA.
Some of these criteria include (but are not limited to) adults 18 and 75 years old who have ongoing lower back pain (for at least 6 months) caused by one degenerated disc in their lower back (between the discs L3 to S1) and have tried other treatments like medicine and physical therapy without success. They also need to be healthy enough to participate and cannot join if they have certain other types of back problems (like those caused from nerve pain have degeneration in more than one disc), infections, serious illnesses, past spine surgeries, or conditions that make the procedure unsafe.
For a complete list of inclusion and exclusion criteria, please visit clinicaltrials.gov.
Additionally, the IDCT trial is being conducted at 30-35 sites across the United States. Potential subjects who may otherwise qualify for the trial but are deemed to live too far away from one of the clinical study sites to complete all in-person assessments over the course of the 2-year study may also be disqualified based on geographic distance.
Is there an IDCT trial site near me?
Many 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. Dr. Peloza is participating in this trial.
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.
Costs and Compensation
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.
Contact Our Practice
To learn more about participating in the IDCT clinical trial with Dr. John Peloza’s site, please call our office at 314.356.2567 or request an appointment using our secure online form.
Complete the Pre-Screening Questionnaire
Click here to take an online pre-screening questionnaire.