Intervertebral Disc DegenerationPhase 1/2NCT07168603
EvaluatIon of Autologous Nucleus Pulposus Cells (aNPC) in Degenerative Disc Disease
A Phase 1/2 study testing aNPC in people with Intervertebral Disc Degeneration, run by ASTEROGENE Biomedical Co. Ltd. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intervertebral Disc Degeneration
- What is being tested?
- aNPC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Sep 2025to 1 Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University Hospital Clinical Research Center
Taipei, 110
Biwen Hsu, +8862-2737-2181, 14042@h.tmu.edu.tw
About this study
Official title: 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 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 recording any treatment-emergent adverse events (AEs). Efficacy will be evaluated using pain assessment and imaging outcomes, including lumbar X-ray and MRI reviewed independently by a radiologist. Additionally, patient-reported outcomes will assess quality of life improvements following treatment using the Visual Analogue Scale (VAS), Activities of Daily Living (ADLs), and the Oswestry Disability Index (ODI). Laboratory tests, including CBC/DC, BUN, creatinine, AST, and ALT, will also be conducted throughout the treatment and observation period to monitor participant safety.
Read the 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 water-retention capacity, allowing it to cushion the vertebrae and reduce friction during movement. However, with aging, the disc gradually loses its water absorption ability and becomes fibrotic, leading to structural degeneration. In addition, sports injuries or sudden mechanical stress may cause disc herniation, compressing spinal nerves and triggering both disc degeneration and back pain. The release of inflammatory mediators further induces severe pain. Once the nucleus pulposus herniates, the tissue continues to degenerate, placing greater stress on the surrounding annulus fibrosus. Over time, this accelerates the progression of DDD.
Regenerative medicine has recently emerged as a promising clinical treatment approach, aiming to restore or rebuild healthy tissue through biological means, with cell therapy being a key area of development. In our approach, autologous cells are harvested from patients' tissue, expanded and activated through ex vivo cell culture, and then reintroduced into the degenerated disc region under X-ray guidance. This autologous cell therapy avoids the risk of immune rejection or transplant-related complications. For patients undergoing treatment for disc herniation, discectomy not only relieves pain symptoms but also provides herniated disc tissue as an ideal source of autologous disc cells for further use in regenerative therapy. These cells can serve as a valuable implant material for disc repair.
The current clinical trial enrolls both male and female subjects aged ≥20 years who have not undergone prior disc surgery. Eligible patients must be diagnosed with disc herniation and scheduled for discectomy, during which nucleus pulposus tissue will be collected for cell culture. Following cell expansion, the cultured cells will be reintroduced into the degenerated disc region via injection. Subjects will undergo multiple follow-up visits within one year after surgery to evaluate safety and efficacy, supplemented with imaging studies to assess disc height, tissue regeneration, and water-retention capacity. Hence, the primary objective of this study is to evaluate the safety of aNPC during the treatment of disc degeneration. Secondary objectives include evaluating the effects of these cells on subjects' quality of life, as measured by Activities of Daily Living (ADLs) and the Oswestry Disability Index (ODI), on pain improvement assessed by the Visual Analogue Scale (VAS), and on imaging outcomes, including lumbar X-ray and MRI assessments, before and after treatment.
This clinical study will be conducted in accordance with the requirements of the Institutional Review Board (IRB) and will fully comply with Good Clinical Practice (GCP) standards and relevant regulations to minimize patient safety risks. In the future, this therapy has the potential to reduce the long-term reliance on pain medications, avoid associated side effects, slow disc degeneration, and alleviate pain and discomfort. Furthermore, it is expected to decrease the need for surgical interventions and provide a more effective and convenient therapeutic option for patients suffering from degenerative disc disease.
- Conditions
- Intervertebral Disc Degeneration
- Being tested
- aNPC
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aNPCDrug
Also called Autologous Nucleus Pulposus Cells
Eligible subjects must be diagnosed with disc herniation and scheduled for discectomy, nucleus pulposus tissue will be collected for cell culture. Cultured cells will be then reintroduced into the degenerated disc via injection. Subjects will undergo multiple follow-up visits after surgery to evaluate safety and efficacy, supplemented with imaging studies to assess disc height, tissue regeneration, and water-retention capacity.
| Study group | Role | What they receive |
|---|---|---|
| aNPC will be injected into the degenerated disc to evaluate safety and efficacy | Experimental | Subjects will receive a single intradiscal injection of autologous nucleus pulposus cells (aNPC) into the degenerated central nucleus pulposus of the affected disc. The injection will be guided by C-arm X-ray to ensure accurate placement, and subjects will be followed for 12 months (52±2 weeks) for safety and efficacy assessments. Receives: Drug: aNPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
ESR: Erythrocyte Sedimentation Rate
A clinical test for detecting acute and chronic inflammation, representing non-specific tissue inflammation or damage. It will be measured to assess infectious inflammatory status, monitor disease progression, and evaluate treatment response.
Unit of Measure: mm/hour
Measured: From enrollment to the end of treatment at 52±2 weeks.
CRP: C-Reactive Protein
A specific protein which increases significantly during bacterial infections. It is a sensitive marker of inflammation and infection, responding more rapidly to changes in disease activity compared to ESR. CRP levels will be measured to assess inflammatory status and monitor therapeutic efficacy.
Measured: From enrollment to the end of treatment at 52±2 weeks.
AE
Adverse events will be monitored and recorded for each participant from baseline through the treatment period. The relationship of each AE to the study treatment will be assessed. Severity and grading of AEs will follow the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0). Unit of Measure: Number and grade of AEs
Measured: From enrollment to the end of treatment at 52±2 weeks.
Secondary outcomes (5)
VAS: Visual Analogue Scale
VAS will be used to assessed pain intensity, which is a 10 cm line (0 to 10 cm) where 0 represents "no pain" and 10 represents "worst imaginable pain." Patients will mark their pain level on the scale, and the score will be recorded from.
Unit of Measure: cm (0-10)
Measured: From enrollment to the end of treatment at 52±2 weeks.
MRI
MRI will be used to evaluate tissue regeneration. Newly formed tissue appears as a deeper, more intense white signal on MRI images. Pre-treatment and post-treatment MRI images will be assessed by an independent radiology expert (not involved in the trial) to determine signal intensity, which will be used as a quantitative measure of tissue regeneration.
Unit of Measure: Signal intensity
Measured: From enrollment to the end of treatment at 52±2 weeks.
Lumbar X-ray
Lumbar X-rays will be used to assess disc degeneration. A decrease in disc height indicates degeneration. Disc height will be measured on pre-treatment and post-treatment X-ray images by independent evaluators, and the change will be used as a quantitative measure of treatment effect.
Unit of Measure: mm
Measured: From enrollment to the end of treatment at 52±2 weeks.
Quality of Life - Activities of Daily Living (ADLs)
ADLs will be assessed using a standardized questionnaire completed by each patient at each study visit. The scores from all items will be averaged to obtain a mean ADL score, which will serve as a reference for evaluating treatment effect on quality of life.
Unit of Measure: Mean score (units on a scale)
Measured: From enrollment to the end of treatment at 52±2 weeks.
Quality of Life - Oswestry Disability Index (ODI)
ODI：The ODI evaluates disability due to low back pain. It consists of 10 sections, each containing 6 statements scored from 0 to 5, with higher scores indicating greater disability. The total ODI score will be calculated pre-treatment and post-treatment to assess changes in patient disability.
Unit of Measure: Total score (0-50)
Measured: From enrollment to the end of treatment at 52±2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start26 Sep 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASTEROGENE Biomedical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168603
- Sponsor's protocol ID
- NPC-001
- Status last verified
- Mar 2026
- First submitted
- 26 Aug 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) for this study. The primary reason is to protect participant privacy and confidentiality. In addition, institutional policy and applicable regulations do not permit release of raw participant-level data.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07168603
- Acronym / sponsor ID
- NPC-001
- Conditions
- Intervertebral Disc Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- ASTEROGENE Biomedical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 recording any treatment-emergent adverse events (AEs). Efficacy will be evaluated using pain assessment and imaging outcomes, including lumbar X-ray and MRI reviewed independently by a radiologist. Additionally, patient-reported outcomes will assess quality of life improvements following treatment using the Visual Analogue Scale (VAS), Activities of Daily Living (ADLs), and the Oswestry Disability Index (ODI). Laboratory tests, including CBC/DC, BUN, creatinine, AST, and ALT, will also be conducted throughout the treatment and observation period to monitor participant safety.
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 water-retention capacity, allowing it to cushion the vertebrae and reduce friction during movement. However, with aging, the disc gradually loses its water absorption ability and becomes fibrotic, leading to structural degeneration. In addition, sports injuries or sudden mechanical stress may cause disc herniation, compressing spinal nerves and triggering both disc degeneration and back pain. The release of inflammatory mediators further induces severe pain. Once the nucleus pulposus herniates, the tissue continues to degenerate, placing greater stress on the surrounding annulus fibrosus. Over time, this accelerates the progression of DDD.
Regenerative medicine has recently emerged as a promising clinical treatment approach, aiming to restore or rebuild healthy tissue through biological means, with cell therapy being a key area of development. In our approach, autologous cells are harvested from patients' tissue, expanded and activated through ex vivo cell culture, and then reintroduced into the degenerated disc region under X-ray guidance. This autologous cell therapy avoids the risk of immune rejection or transplant-related complications. For patients undergoing treatment for disc herniation, discectomy not only relieves pain symptoms but also provides herniated disc tissue as an ideal source of autologous disc cells for further use in regenerative therapy. These cells can serve as a valuable implant material for disc repair.
The current clinical trial enrolls both male and female subjects aged ≥20 years who have not undergone prior disc surgery. Eligible patients must be diagnosed with disc herniation and scheduled for discectomy, during which nucleus pulposus tissue will be collected for cell culture. Following cell expansion, the cultured cells will be reintroduced into the degenerated disc region via injection. Subjects will undergo multiple follow-up visits within one year after surgery to evaluate safety and efficacy, supplemented with imaging studies to assess disc height, tissue regeneration, and water-retention capacity. Hence, the primary objective of this study is to evaluate the safety of aNPC during the treatment of disc degeneration. Secondary objectives include evaluating the effects of these cells on subjects' quality of life, as measured by Activities of Daily Living (ADLs) and the Oswestry Disability Index (ODI), on pain improvement assessed by the Visual Analogue Scale (VAS), and on imaging outcomes, including lumbar X-ray and MRI assessments, before and after treatment.
This clinical study will be conducted in accordance with the requirements of the Institutional Review Board (IRB) and will fully comply with Good Clinical Practice (GCP) standards and relevant regulations to minimize patient safety risks. In the future, this therapy has the potential to reduce the long-term reliance on pain medications, avoid associated side effects, slow disc degeneration, and alleviate pain and discomfort. Furthermore, it is expected to decrease the need for surgical interventions and provide a more effective and convenient therapeutic option for patients suffering from degenerative disc disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aNPC will be injected into the degenerated disc to evaluate safety and efficacy | Experimental | Drug: aNPCSubjects will receive a single intradiscal injection of autologous nucleus pulposus cells (aNPC) into the degenerated central nucleus pulposus of the affected disc. The injection will be guided by C-arm X-ray to ensure accurate placement, and subjects will be followed for 12 months (52±2 weeks) for safety and efficacy assessments. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Main inclusion criteria:
Key exclusion criteria (21 listed)
- 2. Main exclusion criteria:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aNPCAlso: Autologous Nucleus Pulposus CellsEligible subjects must be diagnosed with disc herniation and scheduled for discectomy, nucleus pulposus tissue will be collected for cell culture. Cultured cells will be then reintroduced into the degenerated disc via injection. Subjects will undergo multiple follow-up visits after surgery to evaluate safety and efficacy, supplemented with imaging studies to assess disc height, tissue regeneration, and water-retention capacity. | Drug | aNPC will be injected into the degenerated disc to evaluate safety and efficacy |
Primary outcome
ESR: Erythrocyte Sedimentation Rate
Time frame: From enrollment to the end of treatment at 52±2 weeks.
A clinical test for detecting acute and chronic inflammation, representing non-specific tissue inflammation or damage. It will be measured to assess infectious inflammatory status, monitor disease progression, and evaluate treatment response. Unit of Measure: mm/hour
CRP: C-Reactive Protein
Time frame: From enrollment to the end of treatment at 52±2 weeks.
A specific protein which increases significantly during bacterial infections. It is a sensitive marker of inflammation and infection, responding more rapidly to changes in disease activity compared to ESR. CRP levels will be measured to assess inflammatory status and monitor therapeutic efficacy.
AE
Time frame: From enrollment to the end of treatment at 52±2 weeks.
Adverse events will be monitored and recorded for each participant from baseline through the treatment period. The relationship of each AE to the study treatment will be assessed. Severity and grading of AEs will follow the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0). Unit of Measure: Number and grade of AEs
5 secondary outcomes
VAS: Visual Analogue Scale
Time frame: From enrollment to the end of treatment at 52±2 weeks.
MRI
Time frame: From enrollment to the end of treatment at 52±2 weeks.
Lumbar X-ray
Time frame: From enrollment to the end of treatment at 52±2 weeks.
Quality of Life - Activities of Daily Living (ADLs)
Time frame: From enrollment to the end of treatment at 52±2 weeks.
Quality of Life - Oswestry Disability Index (ODI)
Time frame: From enrollment to the end of treatment at 52±2 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) for this study. The primary reason is to protect participant privacy and confidentiality. In addition, institutional policy and applicable regulations do not permit release of raw participant-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taipei Medical University Hospital Clinical Research Center
Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing aNPC in people with Intervertebral Disc Degeneration, run by ASTEROGENE Biomedical Co. Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ESR: Erythrocyte Sedimentation Rate (time frame: From enrollment to the end of treatment at 52±2 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.