Could stem cells ease stubborn back pain? new trial tests injection therapy
NCT ID NCT03737461
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
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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113 people
The number who actually took part.
- Started
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Feb 2019
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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: * 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.
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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
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APHP Cochin
Paris, France
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BG Klinikum Bergmannstrost
Halle, 06112, Germany
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CHU Saint Antoine
Paris, 75012, France
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CHU de Nantes
Nantes, France
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Campus Bio-Medico University of Rome
Roma, 00128, Italy
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Clínica Universidad de Navarra
Pamplona, 31008, Spain
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Hospital Sagrado Corazón Valladolid
Valladolid, 47002, Spain
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Institut de Teràpia Regenerativa Tissular
Barcelona, 08022, Spain
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UH Montpellier
Montpellier, 34295, France
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