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
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–deri...
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2025-01-01
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| Series: | Cell Transplantation |
| Online Access: | https://doi.org/10.1177/09636897241298128 |
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| author | Mohammadhosein Akhlaghpasand Roozbeh Tavanaei Maede Hosseinpoor Reza Heidari Ida Mohammadi Mohsen Chamanara Melika Hosseinpour Alireza Zali Reza Mosaed Saeed Oraee-Yazdani |
| author_facet | Mohammadhosein Akhlaghpasand Roozbeh Tavanaei Maede Hosseinpoor Reza Heidari Ida Mohammadi Mohsen Chamanara Melika Hosseinpour Alireza Zali Reza Mosaed Saeed Oraee-Yazdani |
| author_sort | Mohammadhosein Akhlaghpasand |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-e500f3530596428b9b63091888ee0fd6 |
| institution | Kabale University |
| issn | 1555-3892 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Cell Transplantation |
| spelling | doaj-art-e500f3530596428b9b63091888ee0fd62025-01-28T22:04:15ZengSAGE PublishingCell Transplantation1555-38922025-01-013410.1177/09636897241298128Effects of Combined Intrathecal Mesenchymal Stem Cells and Schwann Cells Transplantation on Neuropathic Pain in Complete Spinal Cord Injury: A Phase II Randomized Active-Controlled TrialMohammadhosein Akhlaghpasand0Roozbeh Tavanaei1Maede Hosseinpoor2Reza Heidari3Ida Mohammadi4Mohsen Chamanara5Melika Hosseinpour6Alireza Zali7Reza Mosaed8Saeed Oraee-Yazdani9Cancer Epidemiology Research Center, AJA University of Medical Sciences, Tehran, IranFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, IranFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, IranCancer Epidemiology Research Center, AJA University of Medical Sciences, Tehran, IranFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, IranToxicology Research Center, AJA University of Medical Sciences, Tehran, IranFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, IranFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, IranToxicology Research Center, AJA University of Medical Sciences, Tehran, IranFunctional Neurosurgery Research Center, Shohada Tajrish Comprehensive Neurosurgical Center of Excellence, Shahid Beheshti University of Medical Sciences, Tehran, IranNeuropathic 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).https://doi.org/10.1177/09636897241298128 |
| spellingShingle | Mohammadhosein Akhlaghpasand Roozbeh Tavanaei Maede Hosseinpoor Reza Heidari Ida Mohammadi Mohsen Chamanara Melika Hosseinpour Alireza Zali Reza Mosaed Saeed Oraee-Yazdani 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 Cell Transplantation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://doi.org/10.1177/09636897241298128 |
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