Discogenic Low Back PainRENEWDISCNCT07338877
RenewDisc Trial: Endoscopic Discectomy and Autologous Stem Cell Therapy for Discogenic Low Back Pain
An observational study of Discogenic Low Back Pain and Intervertebral Disc Degeneration, run by EPC Education s.r.o. at 1 site in Slovakia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discogenic Low Back Pain, Intervertebral Disc Degeneration, Lumbar Disc Disease
- How many people
- 120 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Oct 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral disc disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At 6, 12, and 24 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Oct 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discogenic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EPC Education s.r.o.
- Sponsor type
- University, hospital or other
- Collaborators
- Slovak Academy of Sciences, Pavol Jozef Safarik University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338877
- Sponsor's protocol ID
- 10148/2024/ODDZ-44592
- Acronym
- RENEWDISC
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RenewDisc Trial: A Prospective Observational Study Comparing Endoscopic Discectomy and Autologous Mesenchymal Stem Cell Therapy in Patients With Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT07338877
- Acronym / sponsor ID
- RENEWDISC / 10148/2024/ODDZ-44592
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- EPC Education s.r.o.University, hospital or other
- Collaborators
- Slovak Academy of Sciences, Pavol Jozef Safarik University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Discogenic Low Back Pain and Intervertebral Disc Degeneration, run by EPC Education s.r.o. at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: From baseline to 24 months after the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.