RenewDisc Trial: Endoscopic Discectomy and Autologous Stem Cell Therapy for Discogenic Low Back Pain

NCT07338877 | Enrolling By Invitation

• 1 other identifier: 10148/2024/ODDZ-44592
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Discogenic Low Back Pain; Intervertebral Disc Degeneration; Lumbar Disc Disease; Chronic Low Back Pain

Keywords

Discogenic Low Back Pain; Endoscopic Discectomy; Mesenchymal Stem Cells; Regenerative Spine Therapy; Lumbar Intervertebral Disc; Minimally Invasive Spine Surgery

Outcome Measures

Primary Outcomes (4)

• Oswestry Disability Index (ODI)

  Outcome Measure Description: The ODI is a validated 10-item, self-administered questionnaire assessing back-specific functional disability. Total score is converted to a 0-100 scale; higher scores indicate greater disability.

  From baseline to 24 months after the procedure

• Change From Baseline in Numerical Rating Scale (NRS) for Back Pain

  The Numerical Rating Scale (NRS) is a patient-reported measure of pain intensity ranging from 0 (no pain) to 10 (worst imaginable pain). Patients rate their average back pain intensity at each assessment time point.

  From baseline to 24 months after the procedure

• Change From Baseline in Visual Analog Scale (VAS) for Leg Pain

  The Visual Analog Scale (VAS) is a 10-cm continuous scale used to assess pain intensity, anchored by "no pain" (0) and "worst imaginable pain" (10).

  From baseline to 24 months after the procedure

• Magnetic Resonance Imaging (MRI) Assessment of Intervertebral Disc Morphology

  MRI evaluation of structural disc changes, including disc height, signal intensity, and degenerative features, assessed at predefined follow-up intervals.

  At 6, 12, and 24 months after the procedure

Other Outcomes (1)

• Change From Baseline in EQ-5D-5L Index Score

  From baseline to 24 months after the procedure

Study Arms (3)

Endoscopic Discectomy Plus Mesenchymal Stem Cell Therapy

Patients with clinically confirmed discogenic low back pain who undergo transforaminal endoscopic discectomy combined with autologous mesenchymal stem cell application as part of routine clinical care. Treatment selection is based on standard clinical decision-making and is not assigned by the study protocol.

Endoscopic Discectomy

Patients with clinically confirmed discogenic low back pain who undergo transforaminal endoscopic discectomy as part of standard clinical practice. The study prospectively observes clinical, functional, and imaging outcomes without assigning treatment.

Endoscopic Mesenchymal Stem Cell Therapy

Patients with clinically confirmed discogenic low back pain who undergo standalone endoscopic application of autologous mesenchymal stem cells as part of routine clinical care. Outcomes are observed prospectively without protocol-driven treatment allocation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients with clinically confirmed discogenic low back pain who are evaluated and treated in specialized spine and pain management centers. Eligible participants have imaging and diagnostic findings consistent with early-stage lumbar intervertebral disc degeneration and are considered suitable candidates for endoscopic spine procedures as part of routine clinical care. Patients are enrolled consecutively based on predefined inclusion and exclusion criteria, without protocol-driven treatment assignment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Slovak Academy of Sciences: collaborator
• Pavol Jozef Safarik University: collaborator
• EPC Education s.r.o.: lead

Study Sites (1)

Poliklinika Terasa

Košice, Košice Region, 04011, Slovakia

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral disc disease

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 14, 2026
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

SL (1)