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Could stem cells ease your aching back?
NCT ID NCT06001853
First seen Jun 24, 2026 · Last updated Jul 07, 2026 · Updated 3 times
Summary
This phase 2 study tests whether bone marrow stem cells can safely reduce pain in people with low back pain from worn-out facet joints. Forty participants will receive injections into the painful joints and be monitored for side effects and pain levels. The goal is to see if this approach works before moving to larger studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bone marrow-derived mesenchymal stem cells
- What this could lead to
- If successful, this could offer a new, non-surgical option for chronic low back pain caused by facet joint arthritis.
- What could go wrong
- This is an early phase 2 trial with only 40 people, so results may not apply to everyone. Stem cell treatments for back pain are still experimental and may not provide lasting relief.
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
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Dec 2027
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 years and older
- 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 To be eligible for inclusion into this study, the subjects must fulfill all the following criteria: 1. Male or female subjects ages 18 and older Persons of childbearing potential must be non-nursing and have a negative serum pregnancy test to be included in the trial and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of up to 12 months following completion of the drug treatment cycle. Persons of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results. If the urine pregnancy test is positive, the study drug will not be administered, and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using a kit. Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcomes. Any SAEs associated with pregnancy will be recorded. The requirement for radiation (X-ray) will be removed. 2. Clinical diagnosis of symptomatic facet joint arthropathy involving the L1-S1 facets. 3. Radiographic evidence of facet arthropathy involving the L1-S1 facets. 4. Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh. Chronic low back pain is defined as the following: * Low back pain for at least 6 months * Subjects should be treated with currently available standard therapies prior to receiving an investigational product, and only subjects who do not have an adequate response to standard therapies. Have at a minimum undergone supervised physical therapy, such as daily walking routines, therapeutic exercises, and back education programs specifically for the treatment of low back pain AND taken a pain medication for back pain (e.g. NSAID and/or opioid medication). * Low back pain of at least 3 to 9 on numeric rating scale (NRS) (average pain in the past 7 days). 5. Confirmation of facet joint related pain by double medial branch blocks with positive results. Positive results are defined as at 75% or more improvement on pain. 6. Full understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments. 7. Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure. Exclusion Criteria Subjects will be excluded from participating in the study if they meet any of the following exclusion criteria: 1. Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI \> 40) 2. Subjects who are pregnant or nursing or subjects planning to become pregnant during the study. If a subject becomes pregnant during the study, the subject will remain in the study and only the requirement for radiation (x-ray) will be removed. 3. Subjects with current or prior history of spinal infection at the symptomatic level (e.g. discitis, septic arthritis, epidural abscess) or an active systemic infection. 4. Subjects with a diagnosis of severe osteoporosis with pathological fracture. 5. Radiofrequency ablation at the index level prior to injection in the past 1 months with positive results. Positive results are defined as at least 50 % pain improvement on NRS back pain scale. 6. Any subject who has had previous intra-articular injection with any medication, at the planned site of MSC treatment, within the last 3 months. 7. Subjects that have undergone a procedure affecting the stability of the index facet joint. The investigator will determine whether the procedure has affected the structure/biomechanics of the index facet joint. 8. Have undergone any procedure within 12 months of the study enrollment using biological treatment for any condition such as bone marrow aspirate concentrate, PRP, bone marrow-derived MSCs, adipose-derived MSCs, SVF, micro fragmented fat, embryonic membrane product etc. 9. Clinically relevant instability on flexion-extension as determined by the primary investigator by overlaying films. 10. Have an acute fracture of the spine at the time of enrollment in the study or clinically compromised vertebral bodies at the affected level due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae. 11. Presence of any of the following spinal deformities: Pars Fractures at any facet level, spondylolisthesis \> grade II at the index facet. 12. Epidural steroid injections within 4 weeks prior to treatment injection. 13. Active malignancy or tumor as a source of symptoms or history of malignancy prior to enrollment in the study, except history of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or squamous cell carcinoma of the cervix if fully excised and with clear margins. 14. An average baseline morphine equivalent dose (MED) of \>50mg/day, as determined by the investigator during Screening consultation. 15. Taking systemic immunosuppressant medications or having a chronic, immunosuppressive state. 16. Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment. 17. Clinically significant abnormal hematology (complete blood count with differential), blood chemistry, or urinalysis screening laboratory results, including PT/INR (\> 1.5), PTT (\< 25 or \> 37 sec), AST(\< 8 or \> 48 U/L), ALT(\< 7 or \> 55 U/L) , alkaline phosphatase (ALP)(\< 40 or \> 129 U/L), bilirubin(\>1.2mg/dL), eGFR (\> 60ml/min/1.73m2), CRP(\> 8.0 mg/L), and ESR(\>22 mm/1h). Clinical significance is to be determined upon investigator's discretion. 18. Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis. 19. Unexplained fever, defined as greater than 100.4 degrees Fahrenheit or 38.0 degrees Celsius, or mental confusion at baseline. 20. Clinically significant cardiovascular (e.g. history of myocardial infarction, congestive heart failure or uncontrolled hypertension ≥ 140mmHg systolic and/or ≥ 90 mmHg diastolic), neurological (e.g. stroke, TIA) renal (eGFR to be \> 60ml/min/1.73m2 and Stage 2, 3 and 4 of chronic kidney disease), hepatic or endocrine disease (e.g. diabetes). Clinical significance is to be determined upon investigator's discretion. 21. Participation in a study of an experimental drug or medical device for treatment of facet joint arthropathy within one year. 22. Any contraindication to MRI according to MRI guidelines or unwillingness to undergo fluoroscopic procedures 23. History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 30 days of study entry, as determined by the investigator during Screening consultation. 24. Any illness or condition which, in the investigators' judgment will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results. 25. Being involved in active litigation related to subject's low back pain. 26. Have a mental illness that could prevent completion of the study or protocol questionnaires. 27. Subjects with a history of bleeding disorders (such as hemophilia). 28. A medical condition, serious intercurrent illness, or extenuating circumstance that would preclude participation in this study or potentially decrease survival r interfere with ambulation or rehabilitation. Examples of conditions that should be excluded are as follows: * history of transient ischemic attack \[TIA\] * history of stroke * uncontrolled diabetes * autoimmune disease (only if it interferes with ambulation or rehabilitation) * muscular dystrophy * rheumatoid arthritis * active liver disease * myelopathy * disorder of bone metabolism (osteomalacia or Paget's disease)
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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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Mayo Clinic in Florida
Jacksonville, Florida, 32224, United States
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