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Back pain breakthrough? own cells injected into damaged discs

NCT ID NCT07168603

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests whether a person's own disc cells, grown in a lab and injected back into the damaged disc, can safely treat degenerative disc disease. Twelve adults with disc herniation and persistent back pain will receive one injection of these cells. Researchers will monitor for side effects and check for pain relief and disc healing over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous nucleus pulposus cells (aNPC)
What this could lead to
If successful, this could point toward a regenerative treatment for degenerative disc disease, potentially reducing pain and improving function without surgery.
What could go wrong
This is a very early, small trial (12 people) focused on safety. The treatment may not work, and there are risks of inflammation or injection-related complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Taipei Medical University Hospital Clinical Research Center

    RECRUITING

    Taipei, 110, Taiwan

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