RenewDisc Trial: Endoscopic Discectomy and Autologous Stem Cell Therapy for Discogenic Low Back Pain (NCT07338877) | Clinical Trial Compass
By InvitationNot Applicable
RenewDisc Trial: Endoscopic Discectomy and Autologous Stem Cell Therapy for Discogenic Low Back Pain
Slovakia120 participantsStarted 2024-10-01
Plain-language summary
he RenewDisc Trial is a prospective observational clinical study evaluating outcomes in patients with confirmed discogenic low back pain who undergo standard clinical care using endoscopic spine procedures. The study observes and compares clinical, functional, and imaging outcomes following endoscopic discectomy, endoscopic discectomy combined with autologous mesenchymal stem cell therapy, or standalone endoscopic application of autologous mesenchymal stem cells.
Participants are treated according to routine clinical decision-making, and no interventions are assigned by the study protocol. Data are collected prospectively at predefined follow-up intervals to assess pain intensity, functional disability, quality of life, and structural changes on magnetic resonance imaging.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 years or older
* Clinical diagnosis of discogenic low back pain
* Positive provocative discography of the target intervertebral disc
* Negative medial branch block
* Preserved lumbar intervertebral disc height greater than 50%
* Pfirrmann grade I-II on lumbar spine MRI
* Back pain with or without radicular pain
* Back pain representing at least 30% of the patient's total reported pain
Exclusion Criteria:
* Lumbar intervertebral disc height reduction greater than 50%
* Presence of Schmorl's nodes in adjacent vertebrae
* Acute or chronic infection
* Presence of hematological disorders
* Back pain representing less than 30% of the patient's total reported pain
* Contraindication to endoscopic spine procedures
* Refusal or inability to provide written informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oswestry Disability Index (ODI)
Timeframe: From baseline to 24 months after the procedure
2
Change From Baseline in Numerical Rating Scale (NRS) for Back Pain
Timeframe: From baseline to 24 months after the procedure
3
Change From Baseline in Visual Analog Scale (VAS) for Leg Pain
Timeframe: From baseline to 24 months after the procedure
4
Magnetic Resonance Imaging (MRI) Assessment of Intervertebral Disc Morphology
Timeframe: At 6, 12, and 24 months after the procedure