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Could a single injection fix your aching back? new trial tests disc repair cells

NCT ID NCT03955315

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
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested an experimental treatment called IDCT (injectable disc cell therapy) in 38 people with chronic low back pain due to degenerative disc disease. Participants received either a low or high dose of the cell therapy or a sham procedure. The goal was to check safety and see if the treatment reduces pain and disability. Results are still being analyzed.

What this could mean

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

Active substance
Injectable disc cell therapy (discogenic cells mixed with sodium hyaluronate)
What this could lead to
If successful, this could lead to a non-surgical treatment that repairs damaged spinal discs and reduces chronic low back pain.
What could go wrong
This is an early phase I/II trial with only 38 participants, so results are preliminary. The treatment may not work better than a sham procedure, and there could be unknown side effects.

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

38 people

The number who actually took part.

Started

May 2019

Finished

Nov 2022

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 75 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: * Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7. * Chronic low-back pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care. * Low-back pain of 40 to 90 mm on the VAS * ODI score of 30 to 90. Exclusion Criteria: * Symptomatic involvement of more than one lumbar disc. * Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, Cauda Equine syndrome, etc. * Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc. * Evidence of dynamic instability on lumbar flexion-extension radiographs. * Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc. * Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology. * Subjects who test positive for communicable disease, have significant systemic disease, or are prone to infection. * Patients who are deemed unsuitable for clinical study participation by the investigator.

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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.

Contacts and locations

Locations

  • Chiba University Hospital

    Chuo-ku, Chiba, 260-8670, Japan

  • Mie University Hospital

    Tsu, Mie-ken, 514-8507, Japan

  • Nagoya university hospital

    Shōwaku, Nagoya, 466-8550, Japan

  • Osaka University Hospital

    Suita, Osaka, 565-0871, Japan

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193, Japan

  • University of Yamanashi Hospital

    Chūō, Yamanashi, 409-3898, Japan

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