Role of stem cells transplantation for patients with spinal cord injury: systematic meta-analysis
Main Article Content
Keywords
PRISMA, Spinal cord injury, BM-MSCs, Heterogeneity
Abstract
Background: Spinal cord injury is a devastating condition that leads to physical, social, and vocational impairment due to the irreversible loss of neural function below the injury site. The objective of this study is to investigate the efficacy and safety of bone marrow mononuclear cells (BM-MNCs) transplant in patients with spinal cord Injury in systematic meta-analysis.
Methods: This systematic review and meta-analysis study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The authors searched the PubMed, Web of Science, Cochrane, and Embase databases, OVID, China Biomedical Database (CBM), SinoMed databases and Library databases up to March 15, 2022. Inclusion criteria included for quantitative review, two well-trained author’s retrieved independently relevant data from articles included for analysis and cross-checked it. In case of disagreements, a third party was consulted to reach a consensus. The methodological quality of the included studies was assessed independently by two reviewers using the Cochrane Collaboration’s ROBINS-I tool for non-randomized studies. Results: Preliminary search database resulted in 549 articles, finally, after excluded all articles did not meet the study criteria 26 studies were included in study and 569 Spinal cord injury patients were included for qualitative analysis in this meta-analysis. Male 77.9% with male/female ration 485/84 variability in the age among included studies. Resulted data showed minor adverse events after bone marrow mononuclear cells (BM-MNCs) transplant; low heterogeneity was observed across each trial (P = 0.11, I2 = 38%). The average risk ratio of these studies was 10.12 (95%CI: 4.24–29.12, p < 0.00003) without heterogeneity (p = 0.81, I2 = 0%) between studies. The methodological quality of the included studies used the standard Cochrane Collaboration tool to analysis is the risk of bias. Conclusions: Bone marrow mononuclear cells (BM-MNCs) significantly improve neurological function in patients with spinal cord injury. Furthermore, this type of procedures has no systemic nor serious complications after autologous transplantation.
References
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11. Deda H, Inci M, Kürekçi A, Kayıhan K, Özgün E, Üstünsoy G, et al. Treatment of chronic spinal cord injured patients with autologous bone marrow-derived hematopoietic stem cell transplantation: 1-year follow-up. Cytotherapy. 2008; 10(6): 565–574.
12. Fan X, Wang JZ, Lin XM, Zhang L. Stem cell transplantation for spinal cord injury: a meta-analysis of treatment effectiveness and safety. Neural Regen Res. 2017; 12(5): 815–825.
13. Muthu S, Jeyaraman M, Gulati A, Arora A. Current evidence on mesenchymal stem cell therapy for traumatic spinal cord injury: systematic review and meta-analysis. Cytotherapy. 2021; 23(3): 186–197.
14. Dlouhy BJ, Awe O, Rao RC, Kirby PA, Hitchon PW. Autograft-derived spinal cord mass following olfactory mucosal cell transplantation in a spinal cord injury patient: case report. J Neurosurg Spine. 2014; 21(4): 618–622.
15. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. Ann Intern Med. 2009; 151(4): 264-269.
16. Song H, Suo S, Ning C, et al. Bone marrow mesenchymal stem cells transplantation on acute spinal cord injury. J Hard Tissue Biol. 2020; 29(2): 91–98.
17. Zhao H, Sun Q-L, Duan L-J, Yang Y-D, Gao Y-S, Zhao D-Y, et al. Is cell transplantation a reliable therapeutic strategy for spinal cord injury in clinical practice? A systematic review and meta-analysis from 22 clinical controlled trials. Eur Spine J. 2019; 28(5): 1092-1112.
18. Cheng H, Liu X, Hua R, Dai G, Wang X, Gao J, An Y. Clinical observation of umbilical
19. Cord mesenchymal stem cell transplantation in treatment for sequelae of thoracolumbar spinal cord injury. J Transl Med 2014; 12:253.
20. Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in Clinical Trials Gov., 2007-2010. JAMA. 2012; 307(17): 1838-1847.
21. Albu S, Kumru H, Coll R, Vives J, Vallés M, Benito-Penalva J, et al. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy. 2021; 23(2): 146-156.
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23. Bhanot Y, Rao S, Ghosh D, Balaraju S, Radhika CR, Kumar KVS. Autologous mesenchymal stem cells in chronic spinal cord injury. Br J Neurosurg. 2011; 25(4): 516-522.
24. Yoon SH, Shim YS, Park YH, Chung JK, Nam JH, Kim MO, et al. Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage- colony stimulating factor: phase I/II clinical trial. Stem cells. 2007; 25(8): 2066-2073.
25. Xiao Z, Tang F, Tang J, Yang H, Zhao Y, Chen B, et al. One-year clinical study of Neuro Regen scaffold implantation following scar resection in complete chronic spinal cord injury patients. Sci China Life Sci. 2016; 59(7): 647-655.
26. El-Kheir WA, Gabr H, Awad MR, et al. Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell Transplant 2014; 23(6): 729-745.
27. Dai G, Liu X, Zhang Z, Yang Z, Dai Y, Xu R. Transplantation of autologous bone marrow mesenchymal stem cells in the treatment of complete and chronic cervical spinal cord injury. Brain Res. 2013; 1533: 73-79.
28. Kishk NA, Gabr H, Hamdy S, Afifi L, Abokresha N, Mahmoud H, Wafaie A, Bilal D. Case control series of intrathecal autologous bone marrow mesenchymal stem cell therapy for chronic spinal cord injury. Neurorehabil Neural Repair. 2010; 24(8): 702-8.
29. Suzuki Y, Ishikawa N, Omae K, Hirai T, Ohnishi K, Nakano N, et al. Bone marrow-derived mononuclear cell transplantation in spinal cord injury patients by lumbar puncture. Restor Neurol Neurosci. 2014; 32(4): 473-482.
30. Sharma A, Sane H, Gokulchandran N, Kulkarni P, Jose A, Nair V, et al. Intrathecal transplantation of autologous bone marrow mononuclear cells in patients with sub-acute and chronic spinal cord injury: an open-label study. Int J Health Sci. 2020; 14(2): 24.
31. Srivastava RN, Agrahari AK, Singh A, Chandra T, Raj S. Effectiveness of bone marrow-derived mononuclear stem cells for neurological recovery in participants with spinal cord injury: A randomized controlled trial. Asian J Transfus Sci. 2019; 13(2): 120-128.
32. Park JH, Kim DY, Sung IY, Choi GH, Jeon MH, Kim KK, et al. Long-term results of spinal cord injury therapy using mesenchymal stem cells
derived from bone marrow in humans. Neurosurgery. 2012; 70(5): 1238-1247.
33. Oraee-Yazdani S, Hafizi M, Atashi A, Ashrafi F, Seddighi A, Hashemi S, et al. Co-transplantation of autologous bone marrow mesenchymal stem cells and Schwann cells through cerebral spinal fluid for the treatment of patients with chronic spinal cord injury: safety and possible outcome. Spinal cord. 2016; 54(2): 102-109.
34. Oh SK, Choi KH, Yoo JY, Kim DY, Kim SJ, Jeon SR. A phase III clinical trial showing limited efficacy of autologous mesenchymal stem cell therapy for spinal cord injury. Neurosurgery. 2016; 78(3): 436-447.
35. Larocca TF, Macêdo CT, de Freitas Souza BS, Andrade-Souza YM, Villarreal CF, Matos AC, et al. Image-guided percutaneous Intralesional administration of mesenchymal stromal cells in subjects with chronic complete spinal cord injury: a pilot study. Cytotherapy. 2017; 19(10): 1189-1196.
36. Jeon SR, Park JH, Lee JH, Kim DY, Kim HS, Sung IY, et al. Treatment of spinal cord injury with bone marrow-derived, cultured autologous mesenchymal stem cells. Tissue Eng Regen Med. 2010; 7(3): 316-322.
37. Goni VG, Chhabra R, Gupta A, Marwaha N, Dhillon MS, Pebam S, et al. Safety profile, feasibility and early clinical outcome of transplantation of olfactory mucosa and bone marrow stem cells in chronic spinal cord injury patients. Asian Spine J. 2014; 8(4): 484.
38. Chhabra H, Sarda K, Arora M, Sharawat R, Singh V, Nanda A, et al. Autologous bone marrow cell transplantation in acute spinal cord injury-an Indian pilot study. Spinal cord. 2016; 54(1): 57-64.
39. Abdelaziz OS, Marie A, Abbas M, Ibrahim M, Gabr H. Feasibility, safety, and efficacy of directly transplanting autologous adult bone marrow stem cells in patients with chronic traumatic dorsal cord injury: a pilot clinical study. Neurosurg Q. 2010; 20(3): 216-226.
40. Saito F, Nakatani T, Iwase M, Maeda Y, Murao Y, Suzuki Y, et al. Administration of cultured autologous bone marrow stromal cells into cerebrospinal fluid in spinal injury patients: a pilot Restorative Neurology and Neuroscience 2012; 30: 127-136.
41. Vaquero J, Zurita M, Rico MA, Bonilla C, Aguayo C, Montilla J, et al. An approach to personalized cell therapy in chronic complete paraplegia: he Puerta de Hierro phase I/II clinical trial. Cytotherapy. 2016; 18(8): 1025-1036.
42. Thakkar UG, Vanikar AV, Trivedi HL, Shah VR, Dave SD, Dixit SB, et al. Infusion of autologousadipose tissue derived neuronal differentiated mesenchymal stem cells and hematopoietic stem cells in post-traumatic paraplegia offers a viable therapeutic approach. Adv Biomed Res. 2016; 5: 51.
43. Adel N, Gabr H, Hamdy S, Afifi L, Mahmoud H. Stem cell therapy in chronic spinal cord injuries. Egypt J Neurol Psychiat Neurosurg. 2009; 46(2): 467-478.
44. Al-Zoubi A, Jafar E, Jamous M, Al-Twal F, Al-Bakheet S, Zalloum M, et al. Transplantation of purified autologous leukapheresis-derived CD34+ and CD133+ stem cells for patients with chronic spinal cord injuries: long-term evaluation of safety and efficacy. Cell Transplant. 2014; 23(1_suppl): 25-34.
45. Deda H, Inci M, Kürekçi A, Kayıhan K, Özgün E, Üstünsoy G, et al. Treatment of chronic spinal
cord injured patients with autologous bone marrow-derived hematopoietic stem cell transplantation: 1-year follow-up. Cytotherapy. 2008; 10(6): 565-574.
46. Yousif NG, Al Kilabi AEK, Hatem KK, Al-Albaseesee HH, Al-Fatlawy WAY, Alhamadani M, Nöth UA, Altmimi A. Autologous hematopoietic bone marrow and concentrated growth factor transplantation combined with core decompression in patients with avascular necrosis of the femoral head. J Med Life. 2023 Jan; 16(1): 76-90.
47. Zingoni GMZ, Castillo PD, Aliperti CP, Horst DJ. Role of bone marrow-derived mesenchymal stem cells in treatment avascular necrosis of femoral head. American Journal of BioMedicine 2022; 10(1): 25-34.
2. Ashammakhi N, Kim H-J, Ehsanipour A, Bierman RD, Kaarela O, Xue C, et al. Regenerative therapies for spinal cord injury. Tissue Eng Part B Rev. 2019; 25(6): 471–491.
3. Lo J, Chan L, Flynn S. A Systematic Review of the Incidence, Prevalence, Costs, and Activity/Work Limitations of Amputation, Osteoarthritis, Rheumatoid Arthritis, Back Pain, Multiple Sclerosis, Spinal Cord Injury, Stroke, and Traumatic Brain Injury in the United States: A 2019 Update. Arch. Phys. Med. Rehabil. 2021; 102: 115.
4. Assinck P, Duncan GJ, Hilton BJ, Plemel JR, Tetzlaff W. Cell transplantation therapy for spinal cord injury. Nat Neurosci. 2017; 20(5): 637–647.
5. Shang Z, Wang R, Li D, Chen J, Zhang B, Wang M, et al. Spinal cord injury: a systematic review and network meta-analysis of therapeutic strategies based on 15 types of stem cells in animal models. Front Pharmacol. 2022; 13: 819861.
6. Tator CH. Review of treatment trials in human spinal cord injury: issues, difficulties, and recommendations. Neurosurgery. 2006; 59(5): 957–987.
7. Cyranoski D. Japan to offer fast-track approval path for stem cell therapies. Nat Med. 2013; 19(5): 510.
8. Tang QR, Xue H, Zhang Q, Guo Y, Xu H, Liu Y, et al. Evaluation of the clinical efficacy of stem cell transplantation in the treatment of spinal cord injury: a systematic review and meta-analysis. Cell Transplant. 2021; 30: 9636897211067804.
9. Albu S, Kumru H, Coll R, Vives J, Vallés M, Benito-Penalva J, et al. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy. 2021; 23(2): 146–156.
10. Chernykh E, Stupak V, Muradov G, Sizikov MY, Shevela EY, Leplina OY, et al. Application of
autologous bone marrow stem cells in the therapy of spinal cord injury patients. Bull Exp Biol Med. 2007; 143(4): 543–547.
11. Deda H, Inci M, Kürekçi A, Kayıhan K, Özgün E, Üstünsoy G, et al. Treatment of chronic spinal cord injured patients with autologous bone marrow-derived hematopoietic stem cell transplantation: 1-year follow-up. Cytotherapy. 2008; 10(6): 565–574.
12. Fan X, Wang JZ, Lin XM, Zhang L. Stem cell transplantation for spinal cord injury: a meta-analysis of treatment effectiveness and safety. Neural Regen Res. 2017; 12(5): 815–825.
13. Muthu S, Jeyaraman M, Gulati A, Arora A. Current evidence on mesenchymal stem cell therapy for traumatic spinal cord injury: systematic review and meta-analysis. Cytotherapy. 2021; 23(3): 186–197.
14. Dlouhy BJ, Awe O, Rao RC, Kirby PA, Hitchon PW. Autograft-derived spinal cord mass following olfactory mucosal cell transplantation in a spinal cord injury patient: case report. J Neurosurg Spine. 2014; 21(4): 618–622.
15. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P Preferred Reporting Items for Systematic Reviews and Meta-Analyses: the PRISMA statement. Ann Intern Med. 2009; 151(4): 264-269.
16. Song H, Suo S, Ning C, et al. Bone marrow mesenchymal stem cells transplantation on acute spinal cord injury. J Hard Tissue Biol. 2020; 29(2): 91–98.
17. Zhao H, Sun Q-L, Duan L-J, Yang Y-D, Gao Y-S, Zhao D-Y, et al. Is cell transplantation a reliable therapeutic strategy for spinal cord injury in clinical practice? A systematic review and meta-analysis from 22 clinical controlled trials. Eur Spine J. 2019; 28(5): 1092-1112.
18. Cheng H, Liu X, Hua R, Dai G, Wang X, Gao J, An Y. Clinical observation of umbilical
19. Cord mesenchymal stem cell transplantation in treatment for sequelae of thoracolumbar spinal cord injury. J Transl Med 2014; 12:253.
20. Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in Clinical Trials Gov., 2007-2010. JAMA. 2012; 307(17): 1838-1847.
21. Albu S, Kumru H, Coll R, Vives J, Vallés M, Benito-Penalva J, et al. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy. 2021; 23(2): 146-156.
22. Waring WP, 3rd, Biering-Sorensen F, Burns S, Donovan W, Graves D, Jha A, et al. review andrevisions of the international standards for the neurological classification of spinal cord injury. J Spinal Cord Med. 2010; 33(4): 346-352.
23. Bhanot Y, Rao S, Ghosh D, Balaraju S, Radhika CR, Kumar KVS. Autologous mesenchymal stem cells in chronic spinal cord injury. Br J Neurosurg. 2011; 25(4): 516-522.
24. Yoon SH, Shim YS, Park YH, Chung JK, Nam JH, Kim MO, et al. Complete spinal cord injury treatment using autologous bone marrow cell transplantation and bone marrow stimulation with granulocyte macrophage- colony stimulating factor: phase I/II clinical trial. Stem cells. 2007; 25(8): 2066-2073.
25. Xiao Z, Tang F, Tang J, Yang H, Zhao Y, Chen B, et al. One-year clinical study of Neuro Regen scaffold implantation following scar resection in complete chronic spinal cord injury patients. Sci China Life Sci. 2016; 59(7): 647-655.
26. El-Kheir WA, Gabr H, Awad MR, et al. Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell Transplant 2014; 23(6): 729-745.
27. Dai G, Liu X, Zhang Z, Yang Z, Dai Y, Xu R. Transplantation of autologous bone marrow mesenchymal stem cells in the treatment of complete and chronic cervical spinal cord injury. Brain Res. 2013; 1533: 73-79.
28. Kishk NA, Gabr H, Hamdy S, Afifi L, Abokresha N, Mahmoud H, Wafaie A, Bilal D. Case control series of intrathecal autologous bone marrow mesenchymal stem cell therapy for chronic spinal cord injury. Neurorehabil Neural Repair. 2010; 24(8): 702-8.
29. Suzuki Y, Ishikawa N, Omae K, Hirai T, Ohnishi K, Nakano N, et al. Bone marrow-derived mononuclear cell transplantation in spinal cord injury patients by lumbar puncture. Restor Neurol Neurosci. 2014; 32(4): 473-482.
30. Sharma A, Sane H, Gokulchandran N, Kulkarni P, Jose A, Nair V, et al. Intrathecal transplantation of autologous bone marrow mononuclear cells in patients with sub-acute and chronic spinal cord injury: an open-label study. Int J Health Sci. 2020; 14(2): 24.
31. Srivastava RN, Agrahari AK, Singh A, Chandra T, Raj S. Effectiveness of bone marrow-derived mononuclear stem cells for neurological recovery in participants with spinal cord injury: A randomized controlled trial. Asian J Transfus Sci. 2019; 13(2): 120-128.
32. Park JH, Kim DY, Sung IY, Choi GH, Jeon MH, Kim KK, et al. Long-term results of spinal cord injury therapy using mesenchymal stem cells
derived from bone marrow in humans. Neurosurgery. 2012; 70(5): 1238-1247.
33. Oraee-Yazdani S, Hafizi M, Atashi A, Ashrafi F, Seddighi A, Hashemi S, et al. Co-transplantation of autologous bone marrow mesenchymal stem cells and Schwann cells through cerebral spinal fluid for the treatment of patients with chronic spinal cord injury: safety and possible outcome. Spinal cord. 2016; 54(2): 102-109.
34. Oh SK, Choi KH, Yoo JY, Kim DY, Kim SJ, Jeon SR. A phase III clinical trial showing limited efficacy of autologous mesenchymal stem cell therapy for spinal cord injury. Neurosurgery. 2016; 78(3): 436-447.
35. Larocca TF, Macêdo CT, de Freitas Souza BS, Andrade-Souza YM, Villarreal CF, Matos AC, et al. Image-guided percutaneous Intralesional administration of mesenchymal stromal cells in subjects with chronic complete spinal cord injury: a pilot study. Cytotherapy. 2017; 19(10): 1189-1196.
36. Jeon SR, Park JH, Lee JH, Kim DY, Kim HS, Sung IY, et al. Treatment of spinal cord injury with bone marrow-derived, cultured autologous mesenchymal stem cells. Tissue Eng Regen Med. 2010; 7(3): 316-322.
37. Goni VG, Chhabra R, Gupta A, Marwaha N, Dhillon MS, Pebam S, et al. Safety profile, feasibility and early clinical outcome of transplantation of olfactory mucosa and bone marrow stem cells in chronic spinal cord injury patients. Asian Spine J. 2014; 8(4): 484.
38. Chhabra H, Sarda K, Arora M, Sharawat R, Singh V, Nanda A, et al. Autologous bone marrow cell transplantation in acute spinal cord injury-an Indian pilot study. Spinal cord. 2016; 54(1): 57-64.
39. Abdelaziz OS, Marie A, Abbas M, Ibrahim M, Gabr H. Feasibility, safety, and efficacy of directly transplanting autologous adult bone marrow stem cells in patients with chronic traumatic dorsal cord injury: a pilot clinical study. Neurosurg Q. 2010; 20(3): 216-226.
40. Saito F, Nakatani T, Iwase M, Maeda Y, Murao Y, Suzuki Y, et al. Administration of cultured autologous bone marrow stromal cells into cerebrospinal fluid in spinal injury patients: a pilot Restorative Neurology and Neuroscience 2012; 30: 127-136.
41. Vaquero J, Zurita M, Rico MA, Bonilla C, Aguayo C, Montilla J, et al. An approach to personalized cell therapy in chronic complete paraplegia: he Puerta de Hierro phase I/II clinical trial. Cytotherapy. 2016; 18(8): 1025-1036.
42. Thakkar UG, Vanikar AV, Trivedi HL, Shah VR, Dave SD, Dixit SB, et al. Infusion of autologousadipose tissue derived neuronal differentiated mesenchymal stem cells and hematopoietic stem cells in post-traumatic paraplegia offers a viable therapeutic approach. Adv Biomed Res. 2016; 5: 51.
43. Adel N, Gabr H, Hamdy S, Afifi L, Mahmoud H. Stem cell therapy in chronic spinal cord injuries. Egypt J Neurol Psychiat Neurosurg. 2009; 46(2): 467-478.
44. Al-Zoubi A, Jafar E, Jamous M, Al-Twal F, Al-Bakheet S, Zalloum M, et al. Transplantation of purified autologous leukapheresis-derived CD34+ and CD133+ stem cells for patients with chronic spinal cord injuries: long-term evaluation of safety and efficacy. Cell Transplant. 2014; 23(1_suppl): 25-34.
45. Deda H, Inci M, Kürekçi A, Kayıhan K, Özgün E, Üstünsoy G, et al. Treatment of chronic spinal
cord injured patients with autologous bone marrow-derived hematopoietic stem cell transplantation: 1-year follow-up. Cytotherapy. 2008; 10(6): 565-574.
46. Yousif NG, Al Kilabi AEK, Hatem KK, Al-Albaseesee HH, Al-Fatlawy WAY, Alhamadani M, Nöth UA, Altmimi A. Autologous hematopoietic bone marrow and concentrated growth factor transplantation combined with core decompression in patients with avascular necrosis of the femoral head. J Med Life. 2023 Jan; 16(1): 76-90.
47. Zingoni GMZ, Castillo PD, Aliperti CP, Horst DJ. Role of bone marrow-derived mesenchymal stem cells in treatment avascular necrosis of femoral head. American Journal of BioMedicine 2022; 10(1): 25-34.
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Apr 15, 2023
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Nasser Ghaly Yousif, Haydar Salih El-Bakaa, Fadhil G. Al-Amranm, & Ulrich Aran Nöth. (2023). Role of stem cells transplantation for patients with spinal cord injury: systematic meta-analysis. Journal of Population Therapeutics and Clinical Pharmacology, 30(7), 211–221. https://doi.org/10.47750/jptcp.2023.30.07.026
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