Effects of Combined Intrathecal Mesenchymal Stem Cells and Schwann Cells Transplantation on Neuropathic Pain in Complete Spinal Cord Injury: A Phase II Randomized Active-Controlled Trial

• Published in: Cell transplantation Vol. 34; p. 9636897241298128
• Main Authors: Akhlaghpasand, Mohammadhosein, Tavanaei, Roozbeh, Hosseinpoor, Maede, Heidari, Reza, Mohammadi, Ida, Chamanara, Mohsen, Hosseinpour, Melika, Zali, Alireza, Mosaed, Reza, Oraee-Yazdani, Saeed
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.01.2025; Sage Publications Ltd; SAGE Publishing
• Subjects: Adult; Cell therapy; Clinical trials; Female; Humans; Injection; Injections, Spinal; Male; Mesenchymal Stem Cell Transplantation - methods; Mesenchymal stem cells; Mesenchymal Stem Cells - cytology; Middle Aged; Multiple regression analysis; Neuralgia; Neuralgia - etiology; Neuralgia - therapy; Original; Pain; Patients; Quality of Life; Schwann cells; Schwann Cells - cytology; Schwann Cells - transplantation; Spinal cord injuries; Spinal Cord Injuries - complications; Spinal Cord Injuries - therapy; Stem cell transplantation; Stem cells; Treatment Outcome; Young Adult; spinal cord injury; mesenchymal stem cell; neuropathic pain; Schwann cell; stem cell therapy
• ISSN: 0963-6897; 1555-3892; 1555-3892
• DOI: 10.1177/09636897241298128

Neuropathic pain is a debilitating complication following spinal cord injury (SCI). Currently, effective treatments for SCI-induced neuropathic pain are highly lacking. This clinical trial aimed to investigate the efficacy of combined intrathecal injection of Schwann cells (SCs) and bone marrow–derived mesenchymal stem cells (BMSCs) in improving SCI-induced neuropathic pain. This study was a parallel-group, randomized, open-label, active-controlled phase II trial with two arms, including treatment and control groups. Patients with complete SCI-induced neuropathic pain in the treatment group received a single combined intrathecal injection of BMSCs and SCs. Study outcome measures were International SCI Pain Basic Data Set (ISCIPBDS) and World Health Organization (WHO) Quality of Life Assessment Instrument (WHOQOL-BREF). A total of 37 (55.2%) and 30 (44.8%) patients in the treatment and control groups were followed up for 6 months, respectively. Significant reductions in mean scores of interference items in the treatment group, including daily activities (P < 0.001), mood (P < 0.001), and sleep (P < 0.001), were found at 6 months after the injection compared with the control one. Similarly, pain frequency (P = 0.002), mean (P = 0.001), and worst (P = 0.001) numeric rating scale (NRS) pain intensity scores showed significant reductions in the treatment group after 6 months compared with the control one. Based on multiple regression analysis controlled for potential confounders, significant associations between changes in all outcome measures over the study period and the treatment group were found. This clinical trial indicated the efficacy of combined cell therapy in improving the neuropathic pain and quality of life in complete SCI patients. Future investigations should evaluate the effects of combination of this strategy with other existing therapies for SCI-induced neuropathic pain. This clinical trial was also registered prospectively at the Iranian Registry of Clinical Trials (IRCT20200502047277N8). Graphical Abstract