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New treatment option for Intervertebral Disc Degeneration
Official title EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease
ClinicalTrials.gov ID: NCT07168603
What this study is testing
What is aNPC?
aNPC is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for intervertebral disc degeneration.
Also referred to as Autologous Nucleus Pulposus Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Main
- 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.
You likely can't join if
- 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...
- Bone marrow function did not meet specific criteria, including appropriate levels of white blood cells, platelets, and hemoglobin. Following the...
- Spinal inflammation, injury, or structural instability, including but not limited to the following：spondylodiscitis, spondylitis, spondylolisthesis...
- Local tissue infection or inflammation near the surgical site.
- Systemic infections require antibiotic treatment.
See the full eligibility criteria
- Main
- 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 people of his own accord.
- 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...
- 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...
- Spinal inflammation, injury, or structural instability, including but not limited to the following：spondylodiscitis, spondylitis, spondylolisthesis, fracture, previous spinal trauma, severe spinal canal stenosis...
- 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.
- people who are not suitable for participating in this clinical trial diagnosed by PI.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.