Safety and potential effects of intrathecal injection of allogeneic human umbilical cord mesenchymal stem cell-derived exosomes in complete subacute spinal cord injury: a first-in-human, single-arm, open-label, phase I clinical trial

Spinal cord injuries often lead to neurological and functional issues due to the limited regeneration of damaged nerve fibers. Exosomes, which are released by mesenchymal stem cells (MSCs), can aid in nerve regeneration. This study examines the safety and possible benefits of using exosomes from human umbilical cord MSCs (HUC-MSCs) in patients with complete subacute spinal cord injuries. The study involved injecting these exosomes directly into the spinal fluid of patients and monitoring them for a year. The researchers looked for any adverse effects and assessed improvements in neurological function, movement, bowel function, muscle spasticity, and urinary tract function. The results indicated that the treatment was safe, with no serious side effects observed. Additionally, some patients showed improvements in sensory function, movement, bowel function, and overall independence. The study suggests that this exosome therapy could be a promising treatment for spinal cord injuries.

• 1
  The intrathecal injection of allogeneic HUC-MSCs-exosomes was safe and well tolerated. No early or late adverse event (AE) attributable to the study intervention was observed.
• 2
  Significant improvements in ASIA pinprick and light touch scores, SCIM III total score, and NBD score were also observed at 12-month after the injection compared with baseline.
• 3
  Four patients demonstrated recovery over the study period based on ASIA motor score.