Allogeneic BM-MSCs in Patients With Painful Lumbar Facet Arthropathy

Inclusion 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.
• . 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.
• . 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.