HELENE CLINIC Academic Paper Abstract Series
Safety and potential effects of intrathecal injection of allogeneic human umbilical cord mesenchymal stem cell-derived exosomes in complete subacute spinal cord injury
Stem Cell Res Ther | 2024 Aug 26 | Akhlaghpasand M et al.
table of contents
Abstract (Japanese translation of Abstract)
Objective
In patients with spinal cord injury (SCI), neurological and functional impairments are commonly observed due to insufficient regeneration of damaged axons. Exosomes play a crucial role in the paracrine action of mesenchymal stem cells (MSCs) and are attracting attention as a promising therapeutic approach for SCI. Therefore, this study aimed to evaluate the safety and potential efficacy of intrathecal administration of allogeneic exosomes derived from human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) in patients with complete subacute spinal cord injury
Methods
This study was conducted as a single-arm, open-label, Phase I clinical trial with a 12-month follow-up period. HUC-MSCs were extracted from human umbilical cord tissue, and exosomes were isolated by ultracentrifugation. After intrathecal administration, each participant underwent a comprehensive evaluation, including neurological assessment using the American Spinal Injury Association (ASIA) scale, functional assessment using the Spinal Cord Independence Measure (SCIM-III), assessment of neurogenic bowel dysfunction using the Neurogenic Bowel Dysfunction (NBD) score, Modified Ashworth Scale (MAS), and assessment using the Lower Urinary Tract Function Questionnaire
Results
Nine patients with complete subacute spinal cord injury were enrolled. Intrathecal administration of allogeneic HUC-MSC-derived exosomes was safe and well-tolerated. No early or late adverse events (AEs) attributable to this intervention were observed. Significant improvements were also observed in the ASIA pinprick sensation score (P=0.039), light touch sensation score (P=0.038), and SCIM-III score
Original information
| item | Content |
|---|---|
| Paper Title | 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. |
| journal | Stem Cell Resistance Ther |
| Announcement date | August 26, 2024 |
| author | Akhlaghpasand M et al. |
| DOI | 10.1186/s13287-024-03868-0 |
Dr. HELENE's opinion
Intrathecal exosome administration is a relatively accessible method of administration and is easy to implement for patients with spinal cord injury. However, the effects on paralysis improvement need to be calmly evaluated in the future