🏛️ Verified NIH Record • Updated 2026-07-01
Allogeneic BM-MSCs in Patients With Painful Lumbar Facet Arthropathy (NCT06001853)
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Mayo Clinic
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (11 items) and avoid the listed exclusions (38 items).
Location: Mayo Clinic in Florida — Jacksonville, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria 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.
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Mayo Clinic in Florida — Jacksonville, Florida
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.