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.

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.

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.

NCT06001853.

Irrational prescribing is a major global health concern, contributing significantly to increased morbidity, mortality and antimicrobial resistance (AMR). Despite existing knowledge and awareness, irrational antibiotic use remains prevalent among healthcare professionals.

This qualitative study aimed to explore the contributing factors to irrational antibiotic prescribing, understand healthcare professionals’ perceptions, identify barriers to rational use and gather suggestions for improving rational antibiotic use.

A qualitative study using semi-structured interviews was conducted with participants. A total of 60 healthcare professionals (20 physicians, 20 pharmacists and 20 nurses) participated after providing verbal consent.

Semi-structured interviews were conducted with healthcare professionals across various clinical settings in Pakistan until data saturation was reached. The Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist was used to ensure transparent reporting. An inductive thematic analysis approach was employed and themes and subthemes were developed from the data.

The findings revealed a generally good understanding of irrational prescribing. Contributing factors included prescriber-related issues, patient expectations, weak regulatory oversight and underutilisation of pharmacists. Key barriers identified were financial constraints, lack of awareness and insufficient resources. Suggestions for improvement included regular audits, public awareness campaigns, an integrated healthcare system, interprofessional collaboration, drug utilisation reviews, adverse drug reaction reporting, standardising hospital policies and strengthening regulatory frameworks.

This study highlights critical factors and barriers contributing to irrational antibiotic prescribing and presents practical suggestions to improve rational use. Implementing evidence-based approaches, updating clinical guidelines, and promoting awareness among healthcare professionals are essential steps toward improving prescribing practices and combating AMR.