EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease

NCT07168603 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: NPC-001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intervertebral Disc Degeneration

Outcome Measures

Primary Outcomes (3)

• 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

  From enrollment to the end of treatment at 52±2 weeks.

• 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.

  From enrollment to the end of treatment at 52±2 weeks.

• 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

  From enrollment to the end of treatment at 52±2 weeks.

Secondary Outcomes (5)

• VAS: Visual Analogue Scale

  From enrollment to the end of treatment at 52±2 weeks.

• MRI

  From enrollment to the end of treatment at 52±2 weeks.

• Lumbar X-ray

  From enrollment to the end of treatment at 52±2 weeks.

• Quality of Life - Activities of Daily Living (ADLs)

  From enrollment to the end of treatment at 52±2 weeks.

• Quality of Life - Oswestry Disability Index (ODI)

  From enrollment to the end of treatment at 52±2 weeks.

Study Arms (1)

aNPC will be injected into the degenerated disc to evaluate safety and efficacy

EXPERIMENTAL

Subjects will receive a single intradiscal injection of autologous nucleus pulposus cells (aNPC) into the degenerated central nucleus pulposus of the affected disc. The injection will be guided by C-arm X-ray to ensure accurate placement, and subjects will be followed for 12 months (52±2 weeks) for safety and efficacy assessments.

Drug: aNPC

Interventions

aNPC DRUG

Eligible 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.

Also known as: Autologous Nucleus Pulposus Cells

aNPC will be injected into the degenerated disc to evaluate safety and efficacy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• VAS score ≥ 6.
• Single lumbar intervertebral disc degeneration or ruptured pinched nerve evaluated by Lumbar X-ray and MRI.
• Informed consent has been signed by subjects of his own accord.

You may not qualify if:

• 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.
• Following the reference range announced by the medical laboratory department at clinical trial institution, as shown below, White blood cells: 4.00-11.00 (\*103/μL); Platelets: 130-140 (\*103/μL); Hemoglobin: Female: 12.0-16.0 (g/dL), Male: 13.0-17.0 (g/dL)
• 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.
• Systemic infections require antibiotic treatment.
• Immunodeficiency disease or current use of immunosuppressive drugs.
• Tumor history.
• Severely degenerated or damaged annulus fibrosis, and the Pfirrman grade exceeds V.
• Hypersensitivity to penicillin, streptomycin, and amphotericin B or similar antibiotics.
• Cannot undergo discectomy.
• Autoimmune disease.
• Blood disease. (ex, anemia, blood coagulation dysfunction, leukemia, ITP, etc.)
• Spinal surgical treatment received.
• Drug allergy.

Sponsors & Collaborators

• ASTEROGENE Biomedical Co. Ltd.: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share