Facet-Mediated Low Back PainPhase 1CellkineNCT04410731
Allogeneic BM-MSCs in Patients with Lumbar Facet Arthropathy
A Phase 1 study testing Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy in people with Facet-Mediated Low Back Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are conducting this study to learn more about the side effects of bone marrow-derived stem cells when injected into the facet joints for the treatment of painful lumbar facet joint arthropathies. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Facet-Mediated Low Back Pain
- What is being tested?
- Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2020to 15 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ages 40-70 years who fulfill the following criteria:
- 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 24 months following completion of the drug treatment cycle.
- Clinical diagnosis of symptomatic facet joint arthropathy involving the L3-S1 facets.
- Radiographic evidence of facet arthropathy involving the L3-S1 facets.
- Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh.
- Confirmation of facet joint related pain by medial branch block with positive results.
- 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.
Who cannot join
- 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 in the first 24 months post-treatment.
- Subjects with current or prior history of spinal infection at the symptomatic level.
- Subjects with a diagnosis of severe osteoporosis with pathological fracture.
- Radiofrequency ablation at the index level prior to injection in the past 3 months with positive results.
- Any lumbar facet intra-articular injection including steroids at the index facet level prior to treatment injection in the past 3 months
Show all 26Show fewer
- Subjects that have undergone a procedure affecting the structure/biomechanics of the index facet joint or a spinal fusion adjacent to the symptomatic level.
- Have undergone any procedure 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.
- Presence of any of the following spinal deformities: spondylolysis at the corresponding 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 within the 5 years 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 elevated average baseline morphine equivalent dose, 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.
- 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, neurological, renal, hepatic or endocrine disease.
- 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 medical marijuana
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CellKine: Phase I Study Evaluating the Safety and Feasibility of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects with Painful Lumbar Facet Joint Arthropathy
Researchers are conducting this study to learn more about the side effects of bone marrow-derived stem cells when injected into the facet joints for the treatment of painful lumbar facet joint arthropathies.
Read the detailed description
Phase I prospective study to determine the safety and feasibility of allogeneic, culture-expanded BM-MSCs in subjects with painful facet-mediated low back pain. Target accrual is 10 subjects with diagnosis of painful lumbar facet joint arthropathy. Eligible subjects will receive a single set of intra-articular bilateral injections of allogeneic, culture-expanded BM-MSCs human, allogeneic, culture expanded, bone-marrow-derived mesenchymal stem cells. Subjects will be evaluated at baseline, treatment day 0, post-operative day 1, post-operative days 3-5, week 2, and months 3, 6, 12, 18 and 24 months post-treatment.
- Conditions
- Facet-Mediated Low Back Pain
- Being tested
- Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy
- Keywords
- lumbar pain, facet joint, arthropathy
- Medical subject headings
- Low Back Pain, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathyDrug
Single bilateral intra-articular injection of manufactured cell cultured expanded allogeneic BM-MSCs for painful lumbar facet joint arthropathy
| Study group | Role | What they receive |
|---|---|---|
| BM-MSC injections for low back pain | Experimental | Single bilateral intra-articular injections of allogeneic BM-MSCs for lumbar facet joint arthropathy Receives: Drug: Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy |
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: 24 months
Self-reported assessment of nature, incidence, and severity of AEs
Spontaneous subject reports
Measured: 24 months
Study personnel assessment of nature, incidence, and severity of AEs
Subject interview by study personnel
Measured: 24 months
Secondary outcomes (21)
Global Health Scale (GHS)
Self-reported questionnaire to assess an individual's 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: 24 months
Visual Analog Scale (VAS) - back and leg pain
Subjective self-reported scale (1-10) to measure acute and chronic pain. (0= no pain; 10= worst pain possible).
Measured: 24 months
Oswestry Disability Index (ODI)
Self-reported index to quantify disability for low back pain. Scores vary from 0 (no back pain) to 5 (worst back pain) in 10 sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling). ODI Index is calculate.
Measured: 24 months
Patient Health Questionnaire-4 (PHQ-4)
Self-reported brief questionnaire to screen for anxiety and depression. Four questions scoring 0 (not at all) to 3 (nearly every day).
Measured: 24 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: 24 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: 24 months
PROMIS-CAT
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: 24 months
Changes from Baseline evaluated by MRI
Imaging evaluation by 2 independent radiographic interpretations to determine presence of effusions, bone marrow lesions/peri-articular edema, osteophytes, or any degree of facet synovitis
Measured: 24 months
Change in number of red blood cells following treatment
Blood will be drawn in order to monitor for markers of systemic inflammation. The normal range of red blood cells varies slightly between laboratories but is generally between 4.2 - 5.9 million cells/cmm. This can also be referred to as the erythrocyte count and can be expressed in international units as 4.2 - 5.9 x 10^12 cells per liter.
Measured: 24 months
Change in white blood cells with differential following treatment
Serological test - Automated white cell differential. A machine generated percentage of the different types of white blood cells, usually split into granulocytes, lymphocytes, monocytes, eosinophils, and basophils.
Measured: 24 months
Change in number of platelets following treatment
Serological test: Platelets are not complete cells, but actually fragments of cytoplasm from a cell found in the bone marrow called a megakaryocyte. Platelets play a vital role in blood clotting. Normal range varies slightly between laboratories but is in the range of 150,000 - 400,000/ cmm (150 - 400 x 10^9/liter).
Measured: 24 months
Change in Serum C-Reactive Protein (CRP)
Serological test: C-reactive protein (CRP) is produced by the liver. The level of CRP rises when there is inflammation throughout the body. It is one of a group of proteins called acute phase reactants that go up in response to inflammation. C-reactive protein is measured in milligrams of CRP per liter of blood (mg/L). Normal CRP levels are below 3.0 mg/dL.
Measured: 24 months
Change in Erythrocyte Sedimentation Rate (ESR)
Serological test. The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour. It is a common hematology test, and is a non-specific measure of inflammation. The normal range is 0-22 mm/hr for men and 0-29 mm/hr for women.
Measured: 24 months
Change in Blood Urea Nitrogen (BUN)
Serological test - basic metabolic panel. A blood urea nitrogen (BUN) test measures the amount of nitrogen in the blood that comes from the waste product urea. Urea is made when protein is broken down in the body. Urea is made in the liver and passed out of the body in the urine. A BUN test is done to see how well the kidneys are working. Results of the blood urea nitrogen test are measured in milligrams per deciliter (mg/dL).
Measured: 24 months
Change in Creatinine
Serological test - basic metabolic panel. Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine. Almost all creatinine is filtered from the blood by the kidneys and released into the urine, so blood levels are usually a good indicator of how well the kidneys are working. Results are reported in mg/dL.
Measured: 24 months
Change in Sodium
Serological test - basic metabolic panel. A sodium blood test allows the doctor to see how much sodium is in the subject's blood. It helps maintain normal blood pressure, supports the work of your nerves and muscles, and regulates your body's fluid balance. A normal sodium level is between 135 and 145 milliequivalents per liter (mEq/L) of sodium.
Measured: 24 months
Change in Potassium
Serological test - basic metabolic panel. The normal potassium level in the blood is 3.5-5.0 milliEquivalents per liter (mEq/L).
Measured: 24 months
Change in Chloride
Serological test - basic metabolic panel. The normal blood reference range of chloride for adults in most labs is 96 to 106 milliequivalents (mEq) per liter.
Measured: 24 months
Change in Aspartate Aminotransferase (AST)
Serological test - basic metabolic panel. Inflamed or injured liver cells leak higher than normal amounts of certain chemicals, including liver enzymes, into the bloodstream, which can result in elevated liver enzymes on blood tests. The reference range for aspartate aminotransferase (AST) is as follows: Males: 6-34 IU/L, Females: 8-40 IU/L.
Measured: 24 months
Change in Glucose
Serological test - basic metabolic panel. For a subject without diabetes, a fasting blood sugar on awakening should be under 100 mg/dl.
Measured: 24 months
Change in Carbon Dioxide
Serological test - basic metabolic panel. The normal range for carbon dioxide is 23 to 29 mEq/L (milliequivalent units per liter of blood).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start28 Apr 2020
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Staggered enrollment for subjects 1 to 3, followed by conditioned open enrollment for subjects 4 to 10.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
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
- NCT04410731
- Sponsor's protocol ID
- 20-000330
- Acronym
- Cellkine
- Status last verified
- Dec 2024
- First submitted
- 14 May 2020
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qu W, Yan D, Durand NC, Wang Z, Lehman VL, Osborne MD, Stone JA, Miller DA, Gupta S, Engelberg-Cook E, Wiest EF, Witter DM, Siebenaler KA, Quinones-Hinojosa A, Zubair AC. Intra-articular delivery of allogeneic bone marrow derived mesenchymal stromal cells (BM-MSCs) for painful lumbar facet arthropathy: a phase I clinical trial. Stem Cell Res Ther. 2025 Oct 30;16(1):596. doi: 10.1186/s13287-025-04674-y.
PubMed 41163019
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CellKine: Phase I Study Evaluating the Safety and Feasibility of Allogeneic, Culture-Expanded Bone Marrow-Derived Mesenchymal Stem Cells in Subjects with Painful Lumbar Facet Joint Arthropathy
- ClinicalTrials.gov ID
- NCT04410731
- Acronym / sponsor ID
- Cellkine / 20-000330
- Conditions
- Facet-Mediated Low Back Pain
- Keywords
- lumbar pain, facet joint, arthropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 1 Jun 2020 (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.
Researchers are conducting this study to learn more about the side effects of bone marrow-derived stem cells when injected into the facet joints for the treatment of painful lumbar facet joint arthropathies.
Detailed description
Phase I prospective study to determine the safety and feasibility of allogeneic, culture-expanded BM-MSCs in subjects with painful facet-mediated low back pain. Target accrual is 10 subjects with diagnosis of painful lumbar facet joint arthropathy. Eligible subjects will receive a single set of intra-articular bilateral injections of allogeneic, culture-expanded BM-MSCs human, allogeneic, culture expanded, bone-marrow-derived mesenchymal stem cells. Subjects will be evaluated at baseline, treatment day 0, post-operative day 1, post-operative days 3-5, week 2, and months 3, 6, 12, 18 and 24 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Staggered enrollment for subjects 1 to 3, followed by conditioned open enrollment for subjects 4 to 10.
| Arm | Type | Receives |
|---|---|---|
| BM-MSC injections for low back pain | Experimental | Drug: Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathySingle bilateral intra-articular injections of allogeneic BM-MSCs for lumbar facet joint arthropathy |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 24 months following completion of the drug treatment cycle.
- Clinical diagnosis of symptomatic facet joint arthropathy involving the L3-S1 facets.
- Radiographic evidence of facet arthropathy involving the L3-S1 facets.
- Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh.
- Confirmation of facet joint related pain by medial branch block with positive results.
Key exclusion criteria (26 listed)
- 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 in the first 24 months post-treatment.
- Subjects with current or prior history of spinal infection at the symptomatic level.
- Subjects with a diagnosis of severe osteoporosis with pathological fracture.
- Radiofrequency ablation at the index level prior to injection in the past 3 months with positive results.
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 |
|---|---|---|
| Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathySingle bilateral intra-articular injection of manufactured cell cultured expanded allogeneic BM-MSCs for painful lumbar facet joint arthropathy | Drug | BM-MSC injections for low back pain |
Primary outcome
Clinical assessment of nature, incidence, and severity of adverse events (AEs)
Time frame: 24 months
Clinical examination face-to-face during follow-up visits
Self-reported assessment of nature, incidence, and severity of AEs
Time frame: 24 months
Spontaneous subject reports
Study personnel assessment of nature, incidence, and severity of AEs
Time frame: 24 months
Subject interview by study personnel
21 secondary outcomes
Global Health Scale (GHS)
Time frame: 24 months
Visual Analog Scale (VAS) - back and leg pain
Time frame: 24 months
Oswestry Disability Index (ODI)
Time frame: 24 months
Patient Health Questionnaire-4 (PHQ-4)
Time frame: 24 months
Narcotic Use Questionnaire
Time frame: 24 months
Work Status Questionnaire
Time frame: 24 months
PROMIS-CAT
Time frame: 24 months
Changes from Baseline evaluated by MRI
Time frame: 24 months
Change in number of red blood cells following treatment
Time frame: 24 months
Change in white blood cells with differential following treatment
Time frame: 24 months
Change in number of platelets following treatment
Time frame: 24 months
Change in Serum C-Reactive Protein (CRP)
Time frame: 24 months
Change in Erythrocyte Sedimentation Rate (ESR)
Time frame: 24 months
Change in Blood Urea Nitrogen (BUN)
Time frame: 24 months
Change in Creatinine
Time frame: 24 months
Change in Sodium
Time frame: 24 months
Change in Potassium
Time frame: 24 months
Change in Chloride
Time frame: 24 months
Change in Aspartate Aminotransferase (AST)
Time frame: 24 months
Change in Glucose
Time frame: 24 months
Change in Carbon Dioxide
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Derived from this study: PubMed 41163019Qu W, Yan D, Durand NC, Wang Z, Lehman VL, Osborne MD, Stone JA, Miller DA, Gupta S, Engelberg-Cook E, Wiest EF, Witter DM, Siebenaler KA, Quinones-Hinojosa A, Zubair AC. Intra-articular delivery of allogeneic bone marrow derived mesenchymal stromal cells (BM-MSCs) for painful lumbar facet arthropathy: a phase I clinical trial. Stem Cell Res Ther. 2025 Oct 30;16(1):596. doi: 10.1186/s13287-025-04674-y.
- 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 1 study testing Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy in people with Facet-Mediated Low Back Pain, 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 8 inclusion and 26 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: finished, as of the sponsor's last update on 19 Dec 2024. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 24 months). The study lists 3 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 NCT04410731, 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 19 Dec 2024.