Efficacy and Safety of Exosomes from Wharton’s Jelly-Derived Mesenchymal Stem Cells in Patients with Spinal Cord Injury

Backgroud: Traumatic spinal cord injury (SCI) is a pathological condition characterized by neurological impairments, the severity of which is contingent upon the level and extent of the injury. In addition to these impairments, SCI is frequently associated with autonomic dysfunctions and complications affecting the cardiovascular and gastrointestinal systems, leading to debilitating consequences such as urinary and bowel incontinence and spasticity, significantly diminishing patients’ quality of life. Aim:This study aimed to evaluate the safety and therapeutic efficacy of mesenchymal stem cell-derived exosomes (MSCdE) in patients with SCI. Methods: Sixteen patients (mean age: 26.25 ± 4.89 years) with SCI resulting from combat-related injuries were enrolled. Of these, 2 patients (12.5%) had lumbar injuries, 11 (68.75%) had thoracic injuries, and 3 (18.75%) had cervical injuries. Exosome administration was performed in 6 treatment cycles over a 4.5-month period. Each cycle involved the intrathecal injection of 3 ml (30 billion) and intramuscular injection of 10 ml (30 billion) of exosomes. Patients were monitored for 1 year following the intervention. Adverse events were assessed according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Neurological function was evaluated using the American Spinal Injury Association Impairment Scale (ASIA), spasticity using the Modified Ashworth Scale (MAS), motor and cognitive function using the Functional Independence Measure (FIM), and urinary and bowel incontinence using the Wexner Incontinence Score and Qualiveen Short Form (SFQ). All assessments were conducted by a multidisciplinary team comprising a neurosurgeon and a specialist in physical therapy and rehabilitation. Results: No serious adverse events were reported throughout the treatment and follow-up period. Minor side effects, such as low-grade fever and localized pain, were observed, classified as CTCAE v5.0 Grade 1, and resolved spontaneously within 24 hours without medical intervention. Statistically significant improvements were noted in all clinical parameters. FIM motor scores increased from 26.75 ± 9.81 pre-treatment to 43.88 ± 17.01 post-treatment (p < 0.01). ASIA motor scores improved significantly from 47.00 ± 21.15 to 56.00 ± 18.74 (p < 0.001), and ASIA sensory scores (light touch/pin-prick) increased from 66.06/66.25 to 77.56/79.75 (p < 0.001). MAS values (right/left) decreased from 7.00/6.94