Facet-Mediated Low Back Pain Clinical Trial
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.
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. Patients with mild to severe facet OA will be considered for this study. A total of 40 patients with diagnosis evidence of chronic low back pain associated with FJOA 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 cross-over to Arm A: treatment then be followed for 12 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04410731 -
Allogeneic BM-MSCs in Patients With Lumbar Facet Arthropathy
|
Phase 1 |