PAIN Reports (Oct 2024)

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

  • Dan Yan,
  • Abba C. Zubair,
  • Michael D. Osborne,
  • Robert Pagan-Rosado,
  • Jeffrey A. Stone,
  • Vance T. Lehman,
  • Nisha C. Durand,
  • Eva Kubrova,
  • Zhen Wang,
  • Drew M. Witter,
  • Meghan M. Baer,
  • Gabriela C. Ponce,
  • Alfredo Quiñones-Hinojosa,
  • Wenchun Qu

DOI
https://doi.org/10.1097/PR9.0000000000001181
Journal volume & issue
Vol. 9, no. 5
p. e1181

Abstract

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Abstract. Background:. 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.