Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could stem cells ease stubborn back pain? new trial tests injection therapy

NCT ID NCT03737461

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 clinical trial tests whether injecting stem cells into the spinal discs can reduce pain and improve function in people with chronic low back pain from degenerative disc disease. About 113 adults aged 18-60 who haven't gotten relief from standard treatments will receive either a stem cell injection or a sham procedure. Researchers will measure pain levels and disability after 12 months to see if the stem cells make a difference.

What this could mean

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

Active substance
allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs)
What this could lead to
If it works, this could offer a new treatment option for people with chronic low back pain that hasn't improved with standard care.
What could go wrong
This is an early-to-mid stage trial with only 113 participants. The stem cell injection may not provide lasting pain relief, and there are risks like infection or nerve damage from the injection procedure.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

113 people

The number who actually took part.

Started

Feb 2019

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age between 18 and 60 years. * Symptomatic chronic low back pain unresponsive to conservative therapy (including physical therapy performed during at least 1 month before inclusion and pain medication with level 2 analgesics in failure or intolerant to level during at least 1 month) for at least 3 months. * DDD assessed by (Pfirrmann's score modified Griffith et al) grade 4 to 7 at one level. If second level, it should be adjacent (Pfirrmann's score 1-4 maximum) * Low back Pain baseline \> 40 mm on VAS (0-100). * NSAID washout of at least 2 days before screening * Painkillers washout of at least 24 hours before screening Exclusion Criteria: * Congenital or acquired diseases leading to spine deformations that may upset cell application (hyperlordosis, scoliosis, isthmus lesion, sacralization and hemisacralization). * Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome on Xray or MRI (osteophyte and facet hypertrophy). * Prior to the screening visit, has received: * Oral corticosteroid therapy within the previous 3 months, OR * Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months * Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion with antero-post translation \> 3 mm and/or angular mobility \> 15°). * Spinal canal stenosis (Schizas score \> B). * History of spinal infection. * Lumbar disc herniation with non truncated sciatica or cruralgia, as well as lumbar cysts and radiculopathy * Previous discal puncture or previous spine surgery. * DDD on 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases * Patients not eligible to the intravertebral disc surgery * Patients who have the risk to undergo a surgery in the next 6 months * Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II). * Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study. * Abnormal blood tests: hepatic (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>1.5 × upper limit of normal (ULN)), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of \<100 × 109/ * Significant medical problems, such as uncontrolled hypertension, symptomatic heart failure; or any other clinically relevant condition or current medication that in the opinion of the investigator contra-indicates the use of any of the study or rescue medications.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Degenerative disc disease (DDD) are added.

Vår säkerhetsrekommendation!

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.

Contacts and locations

Locations

  • APHP Cochin

    Paris, France

  • BG Klinikum Bergmannstrost

    Halle, 06112, Germany

  • CHU Saint Antoine

    Paris, 75012, France

  • CHU de Nantes

    Nantes, France

  • Campus Bio-Medico University of Rome

    Roma, 00128, Italy

  • Clínica Universidad de Navarra

    Pamplona, 31008, Spain

  • Hospital Sagrado Corazón Valladolid

    Valladolid, 47002, Spain

  • Institut de Teràpia Regenerativa Tissular

    Barcelona, 08022, Spain

  • UH Montpellier

    Montpellier, 34295, France

More trials for these conditions

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