{
  "abstract": "Background Lumbar facet arthropathy (LFA) is a degenerative, arthritic joint disorder and a common specific cause of axial low back pain and functional impairment. Currently, no disease-modifying therapies are available for symptomatic LFA. Mesenchymal stem/stromal cell (MSC)-based therapy represents an emerging regenerative treatment modality with the promise to target the underlying pathophysiology of LFA. Despite encouraging clinical evidence supporting the safety and efficacy of MSC therapy in other osteoarthritis, its therapeutic utility in LFA remains largely unexplored. We recently completed a prospective, single-arm, open-label phase I clinical trial that demonstrated a favourable safety profile and preliminary clinical benefit following intra-articular administration of bone marrow-derived MSCs (BMSCs) in patients with symptomatic LFA. Building on these findings, we present the protocol for CellKine II, a prospective, randomised, double-blind, placebo-controlled, cross-over phase II clinical trial to evaluate the safety and preliminary efficacy of intra-articular delivery of allogeneic, culture-expanded BMSCs in patients with painful LFA.Methods and analysis This study is a single-centre, randomised, double-blind, placebo-controlled, cross-over phase II trial with a target accrual of 40 patients. Eligible patients will be randomly assigned in a 1:1 ratio to receive a single intra-articular injection of either Arm A: BMSC or Arm B: Placebo (dimethyl sulfoxide). At the 6-month follow-up, all patients will be unblinded. Patients initially randomised to Arm A will continue follow-up for up to 12 months. Patients initially randomised to Arm B may cross over to receive the BMSC treatment, followed by an additional 12 months of post-BMSC treatment follow-up, or they may continue observation for another 6 months without BMSC treatment. Overall, each patient will be followed up to 12 months after BMSC treatment. The primary endpoints are back pain, functional outcomes and adverse events at 6 months post-randomisation.Ethics and dissemination This study will be conducted in compliance with U.S. federal regulations and Mayo Clinic institutional research policies and procedures. The protocol has been approved by the Mayo Clinic Institutional Review Board (IRB) and the Data Safety Monitoring Board (IRB No. 21-013278). The results of this trial will be disseminated through publication in peer-reviewed journals and on ClinicalTrials.gov.Trial registration number NCT06001853.",
  "authors": [
    {
      "affiliations": [
        "Department of Pain Medicine, Mayo Clinic in Florida, Jacksonville, Florida, USA",
        "Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic in Florida, Jacksonville, Florida, USA"
      ],
      "name": "Dan Yan"
    },
    {
      "affiliations": [
        "Department of Laboratory Medicine and Pathology, Mayo Clinic, Jacksonville, Florida, USA"
      ],
      "name": "Nisha C Durand"
    },
    {
      "affiliations": [
        "Evidence-Based Practice Center, Mayo Clinic, Rochester, Minnesota, USA",
        "Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic Minnesota, Rochester, Minnesota, USA"
      ],
      "name": "Zhen Wang"
    },
    {
      "affiliations": [
        "Department of Pain Medicine, Mayo Clinic in Florida, Jacksonville, Florida, USA"
      ],
      "name": "Michael D Osborne"
    },
    {
      "affiliations": [
        "Department of Radiology, Mayo Clinic, Jacksonville, Florida, USA"
      ],
      "name": "Jeffrey A Stone"
    },
    {
      "affiliations": [
        "Department of Pain Medicine, Mayo Clinic in Florida, Jacksonville, Florida, USA"
      ],
      "name": "Sahil Gupta"
    },
    {
      "affiliations": [
        "Department of Radiology, Mayo Clinic, Jacksonville, Florida, USA"
      ],
      "name": "David A Miller"
    },
    {
      "affiliations": [
        "Center for Clinical and Translational Science, Mayo Clinic, Rochester, Minnesota, USA"
      ],
      "name": "Drew M Witter"
    },
    {
      "affiliations": [
        "Department of Pain Medicine, Mayo Clinic in Florida, Jacksonville, Florida, USA"
      ],
      "name": "Jason S Eldrige"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Mayo Clinic, Jacksonville, Florida, USA"
      ],
      "name": "Alfredo Quiñones-Hinojosa"
    },
    {
      "affiliations": [
        "Department of Laboratory Medicine and Pathology, Mayo Clinic, Jacksonville, Florida, USA"
      ],
      "name": "Abba C Zubair"
    },
    {
      "affiliations": [
        "Department of Pain Medicine, Mayo Clinic in Florida, Jacksonville, Florida, USA",
        "Center for Regenerative Biotherapeutics, Mayo Clinic in Florida, Jacksonville, Florida, USA"
      ],
      "name": "Wenchun Qu"
    }
  ],
  "title": "Safety and preliminary efficacy of allogeneic bone marrow-derived mesenchymal stromal cells (BMSC) for painful lumbar facet arthropathy: study protocol for a randomised, double-blinded, placebo-controlled, crossover phase II clinical trial",
  "uid": "01767099-766b-5750-9bc0-48e73271ef54"
}