This is an open-label, single-center Phase I/II clinical trial investigating the safety and efficacy of autologous nucleus pulposus cells (aNPC) in patients with disc degeneration. Eligible participants are those assessed by the principal investigator to have disc herniation suitable for discectomy and confirmed disc degeneration. During the treatment period, participants will receive a single injection of autologous nucleus pulposus cells at a concentration of approximately 1×10⁶ viable cells/mL with a total volume not exceeding 3 mL. The injection will be guided by C-arm X-ray to ensure accurate placement into the degenerated central nucleus pulposus of the disc from which tissue was previously harvested. Participants will be followed for 12 months. Safety assessments will primarily include monitoring for inflammatory responses using ESR and CRP after cell injection, as well as recording any treatment-emergent adverse events (AEs). Efficacy will be evaluated using pain assessment and imaging outcomes, including lumbar X-ray and MRI reviewed independently by a radiologist. Additionally, patient-reported outcomes will assess quality of life improvements following treatment using the Visual Analogue Scale (VAS), Activities of Daily Living (ADLs), and the Oswestry Disability Index (ODI). Laboratory tests, including CBC/DC, BUN, creatinine, AST, and ALT, will also be conducted throughout the treatment and observation period to monitor participant safety.
Age≧20 years old.
Diagnosed with a disc herniation, can be having a discectomy.
Having low back pain with affecting the lower limbs.
Lower back pain should persist for more than six weeks and fail to improve with conservative treatments.
Levels of coagulation, liver, and kidney functions do not meet reference ranges. Following the reference range announced by the medical laboratory department at clinical trial institution, as shown below, PT/INR: 11-15 (sec)/ INR 0.78-1.12; BUN: 6.0-20.0 (mg/dL); Creatinine: (Female)0.5-0.9 (mg/dL)/ (Male)0.7-1.2 (mg/dL); AST (GOT): < 40 (U/L); ALT (GPT): < 41 (U/L)
Bone marrow function did not meet specific criteria, including appropriate levels of white blood cells, platelets, and hemoglobin.
Spinal inflammation, injury, or structural instability, including but not limited to the following：spondylodiscitis, spondylitis, spondylolisthesis, fracture, previous spinal trauma, severe spinal canal stenosis (hypertrophic fibrosis or ossification oof the ligamentum flavum), spinal tumor, metabolic bone disease.
Local tissue infection or inflammation near the surgical site.
Single group
aNPC
DrugEligible subjects must be diagnosed with disc herniation and scheduled for discectomy, nucleus pulposus tissue will be collected for cell culture. Cultured cells will be then reintroduced into the degenerated disc via injection. Subjects will undergo multiple follow-up visits after surgery to evaluate safety and efficacy, supplemented with imaging studies to assess disc height, tissue regeneration, and water-retention capacity.
ESR: Erythrocyte Sedimentation Rate
A clinical test for detecting acute and chronic inflammation, representing non-specific tissue inflammation or damage. It will be measured to assess infectious inflammatory status, monitor disease progression, and evaluate treatment response. Unit of Measure: mm/hour
CRP: C-Reactive Protein
A specific protein which increases significantly during bacterial infections. It is a sensitive marker of inflammation and infection, responding more rapidly to changes in disease activity compared to ESR. CRP levels will be measured to assess inflammatory status and monitor therapeutic efficacy.
AE
Adverse events will be monitored and recorded for each participant from baseline through the treatment period. The relationship of each AE to the study treatment will be assessed. Severity and grading of AEs will follow the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0). Unit of Measure: Number and grade of AEs
VAS: Visual Analogue Scale
VAS will be used to assessed pain intensity, which is a 10 cm line (0 to 10 cm) where 0 represents "no pain" and 10 represents "worst imaginable pain." Patients will mark their pain level on the scale, and the score will be recorded from. Unit of Measure: cm (0-10)
MRI
MRI will be used to evaluate tissue regeneration. Newly formed tissue appears as a deeper, more intense white signal on MRI images. Pre-treatment and post-treatment MRI images will be assessed by an independent radiology expert (not involved in the trial) to determine signal intensity, which will be used as a quantitative measure of tissue regeneration. Unit of Measure: Signal intensity
Lumbar X-ray
Lumbar X-rays will be used to assess disc degeneration. A decrease in disc height indicates degeneration. Disc height will be measured on pre-treatment and post-treatment X-ray images by independent evaluators, and the change will be used as a quantitative measure of treatment effect. Unit of Measure: mm
Quality of Life - Activities of Daily Living (ADLs)
ADLs will be assessed using a standardized questionnaire completed by each patient at each study visit. The scores from all items will be averaged to obtain a mean ADL score, which will serve as a reference for evaluating treatment effect on quality of life. Unit of Measure: Mean score (units on a scale)
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