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RECRUITING

NCT07168603

PHASE1/PHASE2

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

Sponsor: ASTEROGENE Biomedical Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase I/II Clinical Trial to Evaluate Safety and Efficacy of Autologous Nucleus Pulposus Cells (aNPC) Transplantation in the Treatment of Degenerative Disc Disease

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-09-26

Completion Date

2027-02-01

Last Updated

2026-04-03

Healthy Volunteers

Conditions

Intervertebral Disc Degeneration

Interventions

DRUG

aNPC

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.

Inclusion Criteria: * Main inclusion criteria: 1. Age≧20 years old. 2. Diagnosed with a disc herniation, can be having a discectomy. 3. Having low back pain with affecting the lower limbs. 4. Lower back pain should persist for more than six weeks and fail to improve with conservative treatments. 5. VAS score ≥ 6. 6. Single lumbar intervertebral disc degeneration or ruptured pinched nerve evaluated by Lumbar X-ray and MRI. 7. Informed consent has been signed by subjects of his own accord. Exclusion Criteria: * 2\. Main exclusion criteria: 1. 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) 2. 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) 3. 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. 4. Local tissue infection or inflammation near the surgical site. 5. Systemic infections require antibiotic treatment. 6. Immunodeficiency disease or current use of immunosuppressive drugs. 7. Tumor history. 8. Severely degenerated or damaged annulus fibrosis, and the Pfirrman grade exceeds V. 9. Hypersensitivity to penicillin, streptomycin, and amphotericin B or similar antibiotics. 10. Cannot undergo discectomy. 11. Autoimmune disease. 12. Blood disease. (ex, anemia, blood coagulation dysfunction, leukemia, ITP, etc.) 13. Spinal surgical treatment received. 14. Drug allergy. 15. Have been enrolled in other clinical trials in the past four weeks. 16. Pregnancy and breastfeeding. 17. Positive for HIV or VDRL in blood tests, as well as uncontrolled carriers of hepatitis B or C. 18. Cannot take an MRI scan. 19. Subjects who are not suitable for participating in this clinical trial diagnosed by PI.

Locations (1)

Taipei Medical University Hospital Clinical Research Center

Taipei, Taiwan