CellKine clinical trial: first report from a phase 1 trial of allogeneic bone marrow-derived mesenchymal stem cells in subjects with painful lumbar facet joint arthropathy

• Published in: Pain reports Vol. 9; no. 5; p. e1181
• Main Authors: Yan, Dan, Zubair, Abba C., Osborne, Michael D., Pagan-Rosado, Robert, Stone, Jeffrey A., Lehman, Vance T., Durand, Nisha C., Kubrova, Eva, Wang, Zhen, Witter, Drew M., Baer, Meghan M., Ponce, Gabriela C., Quiñones-Hinojosa, Alfredo, Qu, Wenchun
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Wolters Kluwer 01.10.2024
• Subjects: Musculoskeletal; Research Paper; Musculoskeletal disorders; LFJA; Lumbar facet joint arthropathy; BM-MSCs; Low back pain; Pain management; Clinical trial; Bone marrow-derived mesenchymal stem cells; LBP; Bone marrow–derived mesenchymal stem cells
• ISSN: 2471-2531; 2471-2531
• DOI: 10.1097/PR9.0000000000001181

This report implies a positive outlook regarding the safety and feasibility of administering intra-articular allogeneic bone marrow-derived mesenchymal stem cells, along with potential therapeutic advantages for pain management and functional activities. AbstractBackground:Lumbar facet joint arthropathy (LFJA) is a major cause of low back pain (LBP), with current treatments offering limited long-term benefits. Bone marrow-derived mesenchymal stem cells (BM-MSCs) show promise due to their immunomodulatory and trophic effects, potentially addressing underlying degenerative processes in LFJA.Objectives:This initial report describes the outcomes of the first treated patient in an ongoing mutidisciplinary phase 1 clinical trial evaluating the safety and feasibility of intra-articular allogeneic BM-MSCs for painful LFJA.Methods:Following enrollment in our IRB-approved protocol, symptomatic LFJA was confirmed through double blocks on L4 and L5 medial branches. Two 1-mL syringes, each containing 10 million BM-MSCs, were prepared in the cGMP facility and administered bilaterally to the patient's L4-L5 lumbar facet joints. The patient underwent standardized follow-ups, including clinical examinations and functional and imaging assessments for 2 years, utilizing patient-reported outcomes measurement information system-computer adaptive tests (PROMIS CATs), visual analogue scale, Oswestry disability index, work functional status and opioid pain medication use, and MR imaging Fenton-Czervionke score.Results:The patient tolerated the procedure well, with no drug-related adverse events during the study period. Pain, spine function, and work functional status improved at multiple follow-ups. This patient also reported improvements in mental and social health, along with a notable improvement in the grade of facet synovitis observed at the one-year follow-up MRI evaluation.Conclusions:This case report suggests the safety and feasibility of administering intra-articular allogeneic BM-MSCs, offering therapeutic benefits for pain management and functional activities.