Status:
NOT_YET_RECRUITING
EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease
Lead Sponsor:
ASTEROGENE Biomedical Co. Ltd.
Conditions:
Intervertebral Disc Degeneration
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
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 participan...
Detailed Description
Degenerative disc disease (DDD) commonly occurs in adults and represents an irreversible aging process. It is also one of the primary causes of low-back pain (LBP). The nucleus pulposus possesses high...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- 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.
Exclusion
- 2\. Main exclusion criteria:
- 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.
- Have been enrolled in other clinical trials in the past four weeks.
- Pregnancy and breastfeeding.
- Positive for HIV or VDRL in blood tests, as well as uncontrolled carriers of hepatitis B or C.
- Cannot take an MRI scan.
- Subjects who are not suitable for participating in this clinical trial diagnosed by PI.
Key Trial Info
Start Date :
September 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07168603
Start Date
September 9 2025
End Date
February 1 2027
Last Update
September 11 2025
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