Autologous nucleus pulposus cell injection for degenerative lumbar disc disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-center Phase 1/2 trial harvests autologous nucleus pulposus tissue during discectomy, expands and activates the cells ex vivo, then delivers a single injection of approximately 1×10^6 viable cells/mL (up to 3 mL) back into the same degenerated disc under C-arm X-ray guidance. Participants are followed for 12 months with safety monitoring focused on inflammatory markers (ESR, CRP) and recording treatment-emergent adverse events, and efficacy measured by pain scores and clinical outcomes. The protocol enrolls adults with single-level lumbar disc herniation and persistent high pain despite conservative care. The trial aims to determine whether this autologous cell approach is tolerable and produces meaningful symptom improvement.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taipei Medical University Hospital Clinical Research Center
  Taipei, Taiwan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.