Actively Recruiting
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
Led by ASTEROGENE Biomedical Co. Ltd. · Updated on 2026-04-03
12
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Degenerative disc disease (DDD) is a common condition in adults that causes low-back pain due to the loss of water retention and structural changes in the spinal discs. This trial evaluates the safety and effects of injecting autologous nucleus pulposus cells (aNPC) into degenerated discs in patients with disc herniation requiring discectomy. The study aims to improve pain, quality of life, and disc structure using this regenerative cell therapy. Participants will receive a single injection of their own cultured nucleus pulposus cells into the damaged disc, guided by X-ray for precise placement. The total injection volume will not exceed 3 mL, with about one million viable cells per milliliter. After treatment, subjects will be followed for 12 months to monitor safety and effectiveness. The trial includes imaging studies and patient questionnaires to assess outcomes. During the study, participants will undergo safety tests including blood markers of inflammation, liver and kidney function tests, and monitoring for adverse events. Pain levels will be tracked using the Visual Analogue Scale (VAS) along with assessments of daily activities and disability. Imaging with lumbar X-rays and MRI will be reviewed independently to evaluate disc regeneration and water retention. Follow-ups will occur regularly over the year-long observation period to gather comprehensive data on treatment impact and safety.
CONDITIONS
Brief Title
EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Diagnosed with disc herniation and scheduled for discectomy
- Experiencing low back pain affecting the lower limbs
- Low back pain lasting more than six weeks without improvement from conservative treatments
- Pain level of 6 or higher on the Visual Analogue Scale (VAS)
- Single lumbar disc degeneration or nerve compression confirmed by X-ray and MRI
- Signed informed consent
You will not qualify if you...
- Abnormal coagulation, liver, or kidney function outside defined laboratory ranges
- Bone marrow function outside specified white blood cell, platelet, or hemoglobin levels
- Spinal inflammation, injury, or structural instability such as spondylodiscitis, spondylolisthesis, fractures, severe spinal stenosis, tumors, or metabolic bone disease
- Local or systemic infections requiring treatment
- Immunodeficiency or current immunosuppressant use
- History of tumors
- Severe annulus fibrosis damage beyond Pfirrman grade V
- Allergy to penicillin, streptomycin, amphotericin B, or similar antibiotics
- Unable to undergo discectomy
- Autoimmune or blood diseases
- Previous spinal surgery
- Drug allergies
- Participation in other clinical trials within past four weeks
- Pregnancy or breastfeeding
- Positive HIV, VDRL, or uncontrolled hepatitis B or C
- Unable to have MRI scans
- Deemed unsuitable by the principal investigator for participation in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single injection with follow-up for 12 months (52±2 weeks)
Participants undergo discectomy surgery during which nucleus pulposus tissue is collected. Cultured autologous nucleus pulposus cells (aNPC) are then injected once into the degenerated disc under X-ray guidance.
Multiple follow-up visits over 12 months to evaluate safety and efficacy
Trial Site Locations
Total: 1 location
1
Taipei Medical University Hospital Clinical Research Center
Taipei, Taiwan, 110
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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