Autologous nucleus pulposus cell injection for degenerative lumbar disc disease.
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
This trial will try a single injection of your own nucleus pulposus cells into a degenerated lumbar disc to see if it reduces pain and is safe for people who are having or need a discectomy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | ASTEROGENE Biomedical Co. Ltd. Industry-sponsored |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07168603 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥20 years) with a single-level lumbar disc herniation and confirmed disc degeneration, persistent low back pain with leg symptoms for more than six weeks, VAS ≥6, who are eligible for discectomy and can give informed consent.
Not a fit: Patients with multi-level or advanced degenerative disease, significant spinal instability, major systemic illness, abnormal coagulation/liver/kidney function, bone marrow dysfunction, or those not undergoing tissue-harvesting discectomy are less likely to benefit.
Why it matters
Potential benefit: If successful, this therapy could reduce back and leg pain and help restore disc function, potentially delaying or reducing the need for further spine surgery.
How similar studies have performed: Early-phase human trials and preclinical studies of cell-based disc therapies have shown promising but mixed results, so the approach is partially tested but remains experimental.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Taipei
- Taipei Medical University Hospital Clinical Research Center — Taipei, Taiwan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.