💬In plain words
What the trial is, and whether it could suit you
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 recordi
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
HealthTeky