Safety of bone marrow derived mesenchymal stem cell extracellular vesicle injection for lumbar facet joint pain.
James E WilsonBobbie A TodayMaria SalazarJonathann KuoJohn T RansomAmy L LightnerGrace ChenAnita WongPublished in: Regenerative medicine (2024)
Aim: A 3-month pilot study to evaluate the safety of injecting a bone marrow-derived mesenchymal stem cell extracellular vesicle advanced investigational product (IP) into the lumbar facet joint space as a treatment for chronic low back pain. Methods: 20 healthy adults were treated with IP injections (0.5 ml/joint) and evaluated by three functional assessments 1, 3, 7, 14, 30, 60 and 90 days later. Results: No adverse effects or complications occurred across the 3-month follow-up. There were no reports of worsening pain. After 3 months group average scores improved significantly (p < 0.0001) in the Severity Index (65.04%), Interference Index (72.09%) and Oswestry Disability Index (58.43%) assessments. Conclusion: IP injections were safe and associated with significant functional improvements.
Keyphrases
- mesenchymal stem cells
- chronic pain
- minimally invasive
- ultrasound guided
- umbilical cord
- pain management
- bone marrow
- neuropathic pain
- platelet rich plasma
- multiple sclerosis
- cell therapy
- risk factors
- emergency department
- clinical trial
- randomized controlled trial
- stem cells
- spinal cord injury
- adverse drug
- phase ii
- open label
- newly diagnosed
- study protocol
- double blind