Facet-Mediated Low Back PainPhase 2CELLKINE IINCT06001853
Allogeneic BM-MSCs in Patients With Painful Lumbar Facet Arthropathy
A Phase 2 study testing BM-MSC injection and DSMO Injection in people with Facet-Mediated Low Back Pain and Lumbar Facet Joint Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the safety and effect of bone marrow-derived stem cells for the treatment of low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facet-Mediated Low Back Pain, Lumbar Facet Joint Osteoarthritis
- What is being tested?
- BM-MSC injection and DSMO Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2023to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for inclusion into this study, the subjects must fulfill all the following criteria:
- 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.
- Clinical diagnosis of symptomatic facet joint arthropathy involving the L1-S1 facets.
- Radiographic evidence of facet arthropathy involving the L1-S1 facets.
- Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh.
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- 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).
- 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.
- 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.
- 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.
Who cannot join
- Subjects will be excluded from participating in the study if they meet any of the following exclusion criteria:
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
- 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.
- 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.
- Subjects with a diagnosis of severe osteoporosis with pathological fracture.
- 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.
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- Any subject who has had previous intra-articular injection with any medication, at the planned site of MSC treatment, within the last 3 months.
- 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.
- 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.
- Clinically relevant instability on flexion-extension as determined by the primary investigator by overlaying films.
- 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.
- Presence of any of the following spinal deformities: Pars Fractures at any facet level, spondylolisthesis > grade II at the index facet.
- Epidural steroid injections within 4 weeks prior to treatment injection.
- 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.
- An average baseline morphine equivalent dose (MED) of >50mg/day, as determined by the investigator during Screening consultation.
- Taking systemic immunosuppressant medications or having a chronic, immunosuppressive state.
- Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
- 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.
- Ongoing infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.
- Unexplained fever, defined as greater than 100.4 degrees Fahrenheit or 38.0 degrees Celsius, or mental confusion at baseline.
- 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.
- Participation in a study of an experimental drug or medical device for treatment of facet joint arthropathy within one year.
- Any contraindication to MRI according to MRI guidelines or unwillingness to undergo fluoroscopic procedures
- 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.
- 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.
- Being involved in active litigation related to subject's low back pain.
- Have a mental illness that could prevent completion of the study or protocol questionnaires.
- Subjects with a history of bleeding disorders (such as hemophilia).
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CELLKINE: Phase II Study Evaluating Safety and Preliminary Efficacy of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects With Painful Lumbar Facet Joint Arthropathies
The purpose of this research study is to evaluate the safety and effect of bone marrow-derived stem cells for the treatment of low back pain.
Read the detailed description
This study is a prospective, double blinded, randomized, cross over phase II study evaluating efficacy and safety of intra-articularly injected BM-MSCs in the treatment of painful facet joint arthropathy (FJA). Patients with mild to severe facet arthropathy will be considered for this study.
A total of 40 patients with diagnosis evidence of chronic low back pain associated with FJA and positive outcome of a MBB will be recruited. After confirming eligibility, patients will be randomized to Arm A: Treatment or Arm B: DMSO. After 6 months, patients randomized to Arm B: DMSO will be unblinded and may cross-over to Arm A: treatment then be followed for 12 months.
- Being tested
- BM-MSC injection, DSMO Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM-MSC injectionDrug
BM-MSCs at the dose 10 x 106 in 1 ml per facet joint for a total of 2 joints
DSMO InjectionDrug
After 6 months, patients randomized to Arm B: DMSO will be unblinded and re-assigned to Arm A: treatment then be followed for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Arm A Treatment | Active comparator | Participants in Arm A will be scheduled for a single set of intra-articular injections of allogeneic, culture-expanded BM-MSCs at the dose 10 x106 in 1 ml per facet joint, for a total of 2 joints to be injected. BM-MSC injections will be performed using fluoroscopic guidance. Receives: Drug: BM-MSC injection |
| Arm B: DMSO Crossover | Placebo comparator | Participants in Arm B will receive a DMSO injection. After 6 months, participants randomized to Arm B: DMSO will be unblinded and may cross-over to Arm A: BM-MSC treatment then be followed for 12 months or continue with Arm B for another 6-month follow-up without BM-MSC injections. Each subject will be followed for study endpoints using a predetermined protocol. A final visit for evaluation and imaging will be conducted at the end of the study. Receives: Drug: DSMO Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment of nature, incidence, and severity of adverse events (AEs)
Clinical examination face-to-face during follow-up visits
Measured: Up to 18 months
Self-reported assessment of nature, incidence, and severity of AEs
Spontaneous subject reports
Measured: Up to 18 months
Study personnel assessment of nature, incidence, and severity of AEs
Subject interview by study personnel
Measured: Up to 18 months
PROMIS-CATs
Patient-Reported Outcomes Measurement Information System to evaluate and monitor physical, mental, and social health. Standardized response scores ranges vary from1 to 5 (e.g., 1= None to 5=Very severe) or reversed (5=None to 1=Very severe) to ensure that higher scores for responses always indicate better health.
Measured: Up to 18 months
Numeric Rating Scale (NRS) for low back pain
A visual scale of 0 being "no pain" and 100 being "worst pain Imaginable'" to assess pain status
Measured: Up to 18 months
Secondary outcomes (3)
Changes from baseline evaluated by MRI
Facet anatomical structures with focus on effusion, bone marrow lesions and peri-articular edema, osteophytes and degree of facet synovitis will be assessed
Measured: Up to 18 months
Narcotic Use Questionnaire
Self-reported questionnaire to assess narcotic intake. Four questions to record narcotic drug usage (yes or no), frequency and length.
Measured: Up to 18 months
Work Status Questionnaire
Self-reported short questionnaire to assess work status at present. Simple 3 questions to record ability to work and to attend to work.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start3 Nov 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Facet-Mediated Low Back PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After confirming eligibility, patients will be randomized to Arm A: BM-MSC or Arm B: DMSO. After 6 months, patients randomized to Arm B: DMSO will be unblinded and may cross-over to Arm A: treatment then be followed for 12 months or continue with Arm B for another 6-month follow-up without BM-MSC injections. All patients will be followed up to 12 months after BM-MSCs.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenchun Qu, Mayo Clinic
- Investigators
- Wenchun Qu, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001853
- Sponsor's protocol ID
- 21-013278
- Acronym
- CELLKINE II
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan D, Durand NC, Wang Z, Osborne MD, Stone JA, Gupta S, Miller DA, Witter DM, Eldrige JS, Quinones-Hinojosa A, Zubair AC, Qu W. Safety and preliminary efficacy of allogeneic bone marrow-derived mesenchymal stromal cells (BMSC) for painful lumbar facet arthropathy: study protocol for a randomised, double-blinded, placebo-controlled, crossover phase II clinical trial. BMJ Open. 2026 Jul 20;16(7):e113509. doi: 10.1136/bmjopen-2025-113509.
PubMed 42476734
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CELLKINE: Phase II Study Evaluating Safety and Preliminary Efficacy of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects With Painful Lumbar Facet Joint Arthropathies
- ClinicalTrials.gov ID
- NCT06001853
- Acronym / sponsor ID
- CELLKINE II / 21-013278
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Nov 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the safety and effect of bone marrow-derived stem cells for the treatment of low back pain.
Detailed description
This study is a prospective, double blinded, randomized, cross over phase II study evaluating efficacy and safety of intra-articularly injected BM-MSCs in the treatment of painful facet joint arthropathy (FJA). Patients with mild to severe facet arthropathy will be considered for this study.
A total of 40 patients with diagnosis evidence of chronic low back pain associated with FJA and positive outcome of a MBB will be recruited. After confirming eligibility, patients will be randomized to Arm A: Treatment or Arm B: DMSO. After 6 months, patients randomized to Arm B: DMSO will be unblinded and may cross-over to Arm A: treatment then be followed for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- After confirming eligibility, patients will be randomized to Arm A: BM-MSC or Arm B: DMSO. After 6 months, patients randomized to Arm B: DMSO will be unblinded and may cross-over to Arm A: treatment then be followed for 12 months or continue with Arm B for another 6-month follow-up without BM-MSC injections. All patients will be followed up to 12 months after BM-MSCs.
| Arm | Type | Receives |
|---|---|---|
| Arm A Treatment | Active comparator | Drug: BM-MSC injectionParticipants in Arm A will be scheduled for a single set of intra-articular injections of allogeneic, culture-expanded BM-MSCs at the dose 10 x106 in 1 ml per facet joint, for a total of 2 joints to be injected. BM-MSC injections will be performed using fluoroscopic guidance. |
| Arm B: DMSO Crossover | Placebo comparator | Drug: DSMO InjectionParticipants in Arm B will receive a DMSO injection. After 6 months, participants randomized to Arm B: DMSO will be unblinded and may cross-over to Arm A: BM-MSC treatment then be followed for 12 months or continue with Arm B for another 6-month follow-up without BM-MSC injections. Each subject will be followed for study endpoints using a predetermined protocol. A final visit for evaluation and imaging will be conducted at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- To be eligible for inclusion into this study, the subjects must fulfill all the following criteria:
- 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.
- Clinical diagnosis of symptomatic facet joint arthropathy involving the L1-S1 facets.
- Radiographic evidence of facet arthropathy involving the L1-S1 facets.
Key exclusion criteria (38 listed)
- Subjects will be excluded from participating in the study if they meet any of the following exclusion criteria:
- Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index (BMI > 40)
- 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.
- 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.
- Subjects with a diagnosis of severe osteoporosis with pathological fracture.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BM-MSC injectionBM-MSCs at the dose 10 x 106 in 1 ml per facet joint for a total of 2 joints | Drug | Arm A Treatment |
| DSMO InjectionAfter 6 months, patients randomized to Arm B: DMSO will be unblinded and re-assigned to Arm A: treatment then be followed for 12 months. | Drug | Arm B: DMSO Crossover |
Primary outcome
Clinical assessment of nature, incidence, and severity of adverse events (AEs)
Time frame: Up to 18 months
Clinical examination face-to-face during follow-up visits
Self-reported assessment of nature, incidence, and severity of AEs
Time frame: Up to 18 months
Spontaneous subject reports
Study personnel assessment of nature, incidence, and severity of AEs
Time frame: Up to 18 months
Subject interview by study personnel
PROMIS-CATs
Time frame: Up to 18 months
Patient-Reported Outcomes Measurement Information System to evaluate and monitor physical, mental, and social health. Standardized response scores ranges vary from1 to 5 (e.g., 1= None to 5=Very severe) or reversed (5=None to 1=Very severe) to ensure that higher scores for responses always indicate better health.
Numeric Rating Scale (NRS) for low back pain
Time frame: Up to 18 months
A visual scale of 0 being "no pain" and 100 being "worst pain Imaginable'" to assess pain status
3 secondary outcomes
Changes from baseline evaluated by MRI
Time frame: Up to 18 months
Narcotic Use Questionnaire
Time frame: Up to 18 months
Work Status Questionnaire
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 42476734Yan D, Durand NC, Wang Z, Osborne MD, Stone JA, Gupta S, Miller DA, Witter DM, Eldrige JS, Quinones-Hinojosa A, Zubair AC, Qu W. Safety and preliminary efficacy of allogeneic bone marrow-derived mesenchymal stromal cells (BMSC) for painful lumbar facet arthropathy: study protocol for a randomised, double-blinded, placebo-controlled, crossover phase II clinical trial. BMJ Open. 2026 Jul 20;16(7):e113509. doi: 10.1136/bmjopen-2025-113509.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenchun Qu, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BM-MSC injection and DSMO Injection in people with Facet-Mediated Low Back Pain and Lumbar Facet Joint Osteoarthritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment of nature, incidence, and severity of adverse events (AEs) (time frame: Up to 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06001853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.