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

Europainclinics z.ú.

Status: Invitation-only

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

Study type: Observational

Funder types: Other

Identifiers

NCT07338877

10148/2024/ODDZ-44592

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

Endoscopic Discectomy Plus Mesenchymal Stem Cell Therapy

Description:

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

Description:

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

Description:

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.