RenewDisc Trial: Endoscopic Discectomy and Autologous Stem Cell Therapy for Discogenic Low Back Pain
Enrolling by invitationNCT07338877
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- RenewDisc Trial: A Prospective Observational Study Comparing Endoscopic Discectomy and Autologous Mesenchymal Stem Cell Therapy in Patients With Discogenic Low Back Pain
- Conditions
- Discogenic Low Back Pain
- Intervertebral Disc Degeneration
- Lumbar Disc Disease
- Chronic Low Back Pain
- Sponsor
- EPC Education s.r.o.
- Collaborators
- Slovak Academy of Sciences; Pavol Jozef Safarik University
- Start date
- 2024-10-01
- Primary completion
- 2025-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Slovakia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07338877