Table 1.
Completed clinical trials of stem cell therapy in SCI (https://clinicaltrials.gov/). The table shows the efficacy and safety of stem cell therapy in the management of SCI.
| Identifier | Study Title | Phase | Subjects | Cell Therapy | Route of Administration | Intervention | Efficacy | Security | Ref |
|---|---|---|---|---|---|---|---|---|---|
| Bone Marrow Mesenchymal Stem Cells | |||||||||
| NCT02152657 | Evaluation of Autologous Mesenchymal Stem Cell Transplantation in Chronic Spinal Cord Injury: A Pilot Study | Phase 1 | 5 patients (18–65 years) | BM-MSCs | Percutaneous injection. | MSC transplantation | - | - | - |
| NCT01325103 | Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury | Phase 1 | 14 patients (18–65 years) | BM-MSCs(5 × 106 cells/cm3; single dose) | Intralesional injection | Autologous BM-MSC transplantation | Variable improvements in sensitivity were recorded in all patients and eight of these developed in lower limb motor functions. Seven patients improved AIS. Three subjects ameliorated the neuropathic pain and one presented changes in SSEP. | All patients were discharged within 48 h after surgery. One subject developed complication of cerebrospinal fluid leak, not related to the transplantation but rather to the intervention practices. No patients presented severe side effects or other complications. | [75] |
| NCT02482194 | Autologous Mesenchymal Stem Cells Transplantation for Spinal Cord Injury- A Phase I Clinical Study | Phase 1 | 9 patients (18–50 years) | BM-MSCs (1.2 × 106 cells/kg; two or three dose) | Intrathecal injection | Autologous BM-MSC transplantation | After 1 year of treatment, no participant in the MRI analysis showed a change in the hyperintense signal or presence of ectopic tissue. | No severe side events were recorded in any subjects. One patient complained of severe headaches, while two patients accounted for the non-specific tingling sensation. | [76] |
| NCT01909154 | Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia | Phase 1 | 9 patients (18–50 years) | BM-MSCs (a minimum dose of 100 × 106 and a second dose of 30 × 106 after 3 months) | Intrathecal injection | Autologous BM-MSC transplantation (two doses) | After 12 months, patients had significant sensitivity recovery and an improvement in the level of chronic pain was observed. Seven patients showed the presence of SSEPs and improvement of urodynamic function was recorded. | No serious adverse events were recorded, while adverse events were recorded in each patient. | - |
| NCT01328860 | Autologous Stem Cells for Spinal Cord Injury (SCI) in Children | Phase 1 | 10 children (1–15 years) | BMPCs | Intravenous infusion | Autologous BMPC transplantation | - | - | - |
| NCT01186679 | Safety and Efficacy of Autologous Bone Marrow Stem Cells in Treating Spinal Cord Injury | Phase 1/2 | 12 patients (20–55 years) | BM-MSCs | Intrathecal injection | Autologous BM-MSC transplantation | - | - | - |
| NCT00816803 | Cell Transplant in Spinal Cord Injury Patients | Phase 1/2 | 70 patients (10–36 years) | BM-MSCs | Intrathecal injection | Autologous BM-MSC transplantation | Seventeen of 50 patients treated with BM-MSCs showed achieved ASIA conversion and 17 patients observed an improvement in motor functions. Twelve months later, two patients recorded an improvement of nervous tissue damaged. | Most of the side effects were common with treatment was observed including headache and mild pain, buts all were transitory and totally solved. | [77] |
| NCT02570932 | Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries | Phase 2 | 10 patients (18–70 years) | BM-MSCs (three doses of 100 × 106 cells) | Intrathecal injection | Autologous BM-MSC transplantation | - | - | - |
| Bone Marrow Mesenchymal Stem Cells versus Adipose Tissue-derived Mesenchymal Stem Cells | |||||||||
| NCT02981576 | Safety and Effectiveness of BM-MSC vs. AT-MSC in the Treatment of SCI Patients. | Phase 1/2 | 14 patients (18–70 years) | BM-MSCs and AT-MSCs (three doses) | Intrathecal injection | Autologous BM-MSCs or AT-MSC transplantation | - | - | - |
| Adipose Tissue-derived Mesenchymal Stem Cells | |||||||||
| NCT01274975 | Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury. | Phase 1 | 8 patients (19–60 years) | AT-MSCs (4 × 108 cells; a single dose) | Intravenous infusion | Autologous AT-MSC Transplantation | MRI, 12 weeks after administration of AT-MSCs, showed a reduction of the spinal section injured, but without significant difference (p = 0.8047). In one patient was observed conversion ASIA A scale in ASIA C and he showed an improvement in motor function and sensory functions. | No severe side effects associated with the intravenous administration were recorded. Nineteen adverse events were observed, but all resolved or stabilized during follow-up. | [78] |
| NCT01624779 | Intrathecal Transplantation Of Autologous Adipose Tissue Derived MSC in the Patients With Spinal Cord Injury | Phase 1 | 15 patients (19–70 years) | AT-MSCs (9 × 107 cells/3 mL; three doses) | Intrathecal injection | Autologous AT-MSC Transplantation | - | - | - |
| NCT01769872 | Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury | Phase 1/2 | 15 patients (19–70 years) | AT-MSCs (2 × 108 cells/20 mL, 5 × 107 cells/2 mL and 2 × 107 cells/1 mL cells) | Intravenous, Intrathecal and Intralesional injections | Autologous AT-MSC Transplantation | - | - | - |
| Umbilical Cord Mesenchymal Stem Cells | |||||||||
| NCT01393977 | Difference Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With Spinal Cord Injury in China | Phase 3 | 34 patients (20–50 years) | UC-MSCs (4 × 107 cells) | Intrathecal injection | UC-MSC transplantation and traditional rehabilitation therapy | Seven of 10 subjects that received stem cells showed a significant enhancement in motor functions, auto-self ability and in muscular tension. Five subjects treated with the rehabilitative therapy showed some improvement in the same functions, but they were not statistically significant. | No side effects were recorded. | [79] |
| NCT01873547 | Different Efficacy Between Rehabilitation Therapy and Stem Cells Transplantation in Patients With SCI in China | Phase 3 | 300 patients (20–65 years) | UC-MSCs | Intrathecal injection | UC-MSC transplantation and traditional rehabilitation therapy | - | - | - |
| Neuronal Stem Cells | |||||||||
| NCT01321333 | Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Patients With Thoracic Spinal Cord Injury | Phase 1/2 | 12 patients (18–60 years) | Human CNS-SCs | Intramedullary transplantation | Human CNS-SC transplantation | - | - | - |
| NCT01725880 | Long-Term Follow-Up of Transplanted Human Central Nervous System Stem Cells (HuCNS-SC) in Spinal Cord Trauma Subjects | - | 12 patients (18–60 years) | Human CNS-SCs | Intramedullary transplantation | Human CNS-SC transplantation | - | - | - |
| NCT02163876 | Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury |
Phase 2 | 31 patients (18–60 years) | Human CNS-SCs | Intramedullary transplantation | Human CNS-SC transplantation | - | - | - |
| NCT02302157 | Dose Escalation Study of AST-OPC1 in Spinal Cord Injury | Phase 1/2 | 25 patients (18–69 years) | AST-OPC1 (10 million cells; two doses) | - | AST-OPC1 transplantation | - | - | - |
MSCs, Mesenchymal Stem Cells; BM-MSCs, Bone Marrow MSCs; BMPCs, Bone Marrow Progenitor Cells; AT-MSCs, Adipose Tissue-derived MSCs; CNS-SCs, Central nervous System Stem Cells; UC-MSCs, Umbilical Cord MSCs; AIS, Association Impairment Scale; SSEP, Somatosensory Evoked Potentials; MRI, Magnetic Resonance Image.