Please sign in to follow a disease.
Back pain breakthrough? own cells injected into damaged discs
NCT ID NCT07168603
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Degenerative disc disease are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGTaipei, 110, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A conversation before spine surgery could change how patients recover
- Can a new bone graft match the gold standard for spinal fusion?
- Can a nanotube surface help spinal bones fuse faster?
- Can a growth factor from donor bone improve spinal fusion?
- 3D-Printed spinal cages could revolutionize back surgery
- Bone scan may help avoid unnecessary back surgery