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

January 4, 2026 updated by: Europainclinics z.ú.

RenewDisc Trial: A Prospective Observational Study Comparing Endoscopic Discectomy and Autologous Mesenchymal Stem Cell Therapy in Patients With Discogenic Low Back Pain

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 Overview

Status

Enrolling by invitation

Conditions

Detailed Description

Discogenic low back pain is a frequent cause of chronic disability and remains challenging to treat when conservative management fails. Endoscopic spine techniques have emerged as minimally invasive options that allow targeted treatment of disc pathology with reduced tissue trauma. In parallel, regenerative approaches using autologous mesenchymal stem cells have gained interest due to their potential biological effects on disc degeneration.

The RenewDisc Trial is designed as a prospective observational cohort study to systematically collect and analyze real-world clinical data from patients with confirmed discogenic low back pain who undergo endoscopic spine procedures as part of routine clinical care. The study does not assign or randomize treatments. All therapeutic decisions, including the choice of procedure, are made independently by the treating physician based on standard clinical indications and patient preference.

Patients included in the study undergo one of the following standard clinical approaches: endoscopic discectomy, endoscopic discectomy combined with autologous mesenchymal stem cell application, or standalone endoscopic application of autologous mesenchymal stem cells. These approaches represent established clinical practices at participating centers. The study observes outcomes associated with each approach without altering standard care pathways.

Clinical outcomes are assessed prospectively using validated patient-reported outcome measures, including pain intensity scales, functional disability, and health-related quality of life. Imaging follow-up with magnetic resonance imaging is performed at predefined intervals to evaluate structural changes of the intervertebral disc. In patients undergoing bone marrow aspiration as part of standard care, cellular characteristics of the aspirate are analyzed descriptively.

Data are collected at baseline and during scheduled follow-up visits and are recorded using anonymized, randomly generated participant identifiers. The study aims to provide comparative real-world evidence on clinical, functional, and imaging outcomes associated with contemporary endoscopic and regenerative spine treatment strategies for discogenic low back pain.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
    • Košice Region
      • Košice, Košice Region, Slovakia, 04011
        • Poliklinika Terasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Disability Index (ODI)
Time Frame: From baseline to 24 months after the procedure

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
Time Frame: From baseline to 24 months after the procedure
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
Time Frame: From baseline to 24 months after the procedure
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
Time Frame: At 6, 12, and 24 months after the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in EQ-5D-5L Index Score
Time Frame: From baseline to 24 months after the procedure

Outcome Measure Description:

EQ-5D-5L is a standardized measure of health-related quality of life across five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The index score is derived from the five-digit health state.
From baseline to 24 months after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Europainclinics z.ú.

Collaborators

Pavol Jozef Safarik University
Slovak Academy of Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 4, 2026

First Submitted That Met QC Criteria

January 4, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 4, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10148/2024/ODDZ-44592

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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