Multiroute Administration of Wharton’s Jelly Mesenchymal Stem Cells in Chronic Complete Spinal Cord Injury: A Phase I Safety and Feasibility Study | Newswise
BACKGROUND
Newswise — Traumatic spinal cord injury (SCI) is a life-altering condition that results in long-term complications, including progressive neurodegeneration and cord atrophy. It presents a significant unmet medical need with extensive social and economic burdens.
AIM
To evaluate the safety and preliminary efficacy of allogeneic mesenchymal stem cells derived from Wharton’s jelly (WJ-MSCs) in patients with chronic complete SCI. The primary objective was to assess whether WJ-MSCs could facilitate neurological recovery and improve the quality of life in this patient population.
METHODS
This open-label, multicenter phase I study investigated the effects of administering WJ-MSCs via three delivery routes: Intrathecal (for localized spinal targeting); intramuscular (for targeting end organ); and intravenous (for systemic immunomodulation). While all three routes were used concurrently to enhance therapeutic synergy, neurological, sensory, and functional scales were used to assess overall efficacy. Participants with chronic SCI (duration of at least 6 months) who had significant impairment and disability were eligible for inclusion. WJ-MSCs were administered twice monthly for 2 months, with each route receiving a dose of 1 × 106 cells/kg. Patients were closely monitored for 1 year following treatment.
RESULTS
At baseline, participants displayed considerable functional deficits, as indicated by the following scores: Functional independence measure of 77.5 ± 2.26; Modified Ashworth Scale of 15.83 ± 4.83; American Spinal Injury Association (ASIA) Motor score of 1.67 ± 2.66; ASIA Light Touch and Pin-Prick scores of 62 ± 18.42 each; Wexner Incontinence Score of 20; and Qualiveen Short Form, a validated questionnaire specifically designed to assess the impact of urinary dysfunction on quality of life in individuals with SCI, score of 32. Following WJ-MSC therapy, significant improvements were observed in all neurological functions over the 1-year follow-up. Notably, the ASIA Motor score improved significantly (χ2 = 23.938, P < 0.001), and Qualiveen Short Form scores demonstrated a substantial enhancement in quality of life (z = -2.214, P < 0.05).
CONCLUSION
This phase I study, conducted without a control group, suggests that the administration of WJ-MSCs through multiple routes is both safe and potentially effective in patients with chronic complete SCI. However, the observed neurological improvements cannot be solely attributed to WJ-MSC therapy, as concurrent pharmacological and rehabilitative interventions were not controlled. These findings indicated that WJ-MSC therapy may offer a promising approach for enhancing neurological function and quality of life in this challenging patient population. Further research with larger cohorts and extended follow-up is necessary to validate these preliminary results.
Key Words: Spinal cord injury; Mesenchymal stem cell; Transplantation; Wharton’s jelly; Neurological recovery
Core Tip: Spinal cord injury causes severe disability with significant impairments in sensory and motor functions and dysfunction in multiple organs. We investigated the therapeutic potential of Wharton’s jelly-derived mesenchymal stem cells administered through a triple-route delivery system (intrathecal, intramuscular, and intravenous). The treatment resulted in significant improvements in motor and sensory functions. Patients experienced an improved quality of life. The procedure was well-tolerated with no significant side effects or safety concerns. No adverse events were reported highlighting the potential of Wharton’s jelly-derived mesenchymal stem cell therapy as a safe and effective treatment option for individuals with chronic spinal cord injury.
