Allogeneic BM-MSCs in Patients with Lumbar Facet Arthropathy
NCT ID: NCT04410731
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2020-04-28
2024-03-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BM-MSC injections for low back pain
Single bilateral intra-articular injections of allogeneic BM-MSCs for lumbar facet joint arthropathy
Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy
Single bilateral intra-articular injection of manufactured cell cultured expanded allogeneic BM-MSCs for painful lumbar facet joint arthropathy
Interventions
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Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy
Single bilateral intra-articular injection of manufactured cell cultured expanded allogeneic BM-MSCs for painful lumbar facet joint arthropathy
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. Clinical diagnosis of symptomatic facet joint arthropathy involving the L3-S1 facets.
3. Radiographic evidence of facet arthropathy involving the L3-S1 facets.
4. Chronic low back pain with or without referred pain to the buttock, groin, or proximal thigh.
5. Confirmation of facet joint related pain by medial branch block with positive results.
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.
Exclusion Criteria
2. Subjects who are pregnant or nursing or subjects planning to become pregnant in the first 24 months post-treatment.
3. Subjects with current or prior history of spinal infection at the symptomatic level.
4. Subjects with a diagnosis of severe osteoporosis with pathological fracture.
5. Radiofrequency ablation at the index level prior to injection in the past 3 months with positive results.
6. Any lumbar facet intra-articular injection including steroids at the index facet level prior to treatment injection in the past 3 months
7. Subjects that have undergone a procedure affecting the structure/biomechanics of the index facet joint or a spinal fusion adjacent to the symptomatic level.
8. 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.
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.
11. Presence of any of the following spinal deformities: spondylolysis at the corresponding 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 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.
14. An elevated average baseline morphine equivalent dose, 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.
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, neurological, renal, hepatic or endocrine disease.
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 medical marijuana
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.
40 Years
70 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Wenchun Qu
Associate Professor of Anesthesiology and Physical Medicine and Rehabilitation
Principal Investigators
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Wenchun Qu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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References
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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.
Other Identifiers
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20-000330
Identifier Type: -
Identifier Source: org_study_id