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Could stem cells fix your aching back? new trial tests injection after disc surgery

NCT ID NCT06589271

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether injecting stem cells from donated umbilical cords into the spine can help repair degenerated discs in people with lower back and leg pain. Twenty patients who have not improved with other treatments will receive the injection right after a minimally invasive disc surgery. Researchers will track changes on MRI scans and pain scores over a year to see if the treatment is safe and might help the disc heal.

What this could mean

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

Active substance
human umbilical cord mesenchymal stem cells
What this could lead to
If it works, this could point toward a minimally invasive way to repair damaged spinal discs and reduce the need for repeat surgeries.
What could go wrong
This is a very early (phase 1) trial with only 20 participants, so safety and effectiveness are not yet proven. The study is currently suspended, and stem cell injections carry risks like infection or immune reactions.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

18 to 60 years

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: 1. Age: 18-60 years old; 2. The symptoms are lumbago combined with radiating pain of one lower limb; 3. Failed conservative treatment for 3 months, including physical therapy, manual therapy and non-morphine drug therapy; 4. CT/MRI clearly highlighted the nucleus pulposus pressing the nerve root and the location was consistent; 5. Symptoms and imaging showed unilateral lumbar disc herniation; 6. Imaging showed single-level lumbar disc herniation; 7. MRI (T2WI) of Pfirrmann disc degeneration: Grade I-IV; 8. Lumbar disc herniation segments: L3-4, L4-5, L5-S1; 9. Unilateral full endoscopic extraction of nucleus pulposus; 10. Sign the informed consent; 11. No previous history of spinal surgery. Exclusion Criteria: 1. Previous history of tumor and spinal infection; 2. Patients with severe coagulation disorders, a history of drug abuse or taking oral anticoagulants; 3. Coma or incapacitation; 4. MRI contraindications (history of cardiovascular and cerebrovascular stent implantation, pacemaker, biostimulator, etc.); 5. Pregnant women; 6. Pregnancy or breastfeeding; 7. Have participated in other clinical trials related to this project within the past 30 days; 8. Those who have received stem cell therapy; 9. Poor compliance, or can not correctly understand the cooperation so that it can not complete the interview; 10. Received intervertebral disc interventional therapy within the past 3 months, such as radiofrequency, laser ablation, protease injection, Ozone injection; 11. Highly allergic or have a history of severe allergies; 12. Patients with severe autoimmune disease or who are receiving immunosuppressive therapy; 13. Serious uncontrolled infection or high fever; 14. Patients with shock, failure of vital organs and unstable vital signs; 15. X-ray showed that the degree of stenosis of the diseased segment was more than 30% compared with the adjacent normal segment; 16. Imaging showed lumbar disc herniation complicated with calcification; 17. Imaging showed lumbar disc herniation with Modic Change; 18. Imaging showed lumbar disc herniation complicated with severe spinal stenosis; 19. Imaging showed lumbar disc herniation complicated with lumbar spondylolisthesis; 20. Imaging showed lumbar disc herniation combined with spinal deformity; 21. Mental disorders, cognitive disorders, or other physical diseases affecting the research results; 22. Doctors believe that there are other reasons for not being included in the treatment.

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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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Shanghai General Hospital

    Shanghai, 200080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.