Table 1.
Clinical trials of cell transplantation to SCI patients. “AIS” indicates ASIA (American Spinal Injury Association) impairment scale. Abbreviations are defined as follows: BMSCs: bone marrow stromal cells; OECs: olfactory ensheathing cells; IT: intrathecal administration; IV: intravenous administration; DI: direct injection surrounding the lesion; IA: intra-arterial administration; CSF: cerebrospinal fluid; SSEP: somatosensory evoked potential.
| Reference | Patient profiles | Transplanted cells | Evaluation and outcome | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| AIS | Level of injury | No. of Patients | Period from injury to transplant | Cell type | Amount | Method for delivery | Observation period | Outcomes | Adverse effects | |
|
Callera et al. [35] |
unknown | 7 paraplegia, 3 tetraplegia | 10 | chronic? (mean: 3 y) | autologous BMSCs (mononuclear cells, CD34+ cells) | 1 × 108 cells (mononuclear cells), 1 × 106 cells (CD34+ cells) | IT | 12 w | No transplanted cells in CSF after 7 d | None |
|
Moviglia et al. [36] |
unknown | C2, T6 | 2 | chronic (8 m, 30 m) | autologous BMSCs, autoimmune T (AT) cells | 5–10 × 108 cells (AT cells), 1.5–2 × 108 cells (BMSCs) | IV (AT cells), IA (BMSCs) | 3–6 m | Neurological recovery | None |
|
Yoon et al. [37] |
A? | 23 paraplegia, 12 tetraplegia | 35 | acute (n = 17), subacute (n = 6), chronic (n = 12) | autologous BMSCs | 2 × 108 cells | DI | 10.4 m | No tumor formation Neurological improvement (30.4% in acute and subacute) |
Fever (62.9%) Neuropathic pain (20%) |
| Syková et al. [38] |
A | C4-T11 | 20 | subacute (n = 8), chronic (n = 12) | autologous BMSCs | 104.0 ± 55.3 × 108 (mononuclear cells), 89.7 ± 70.7 × 106 (CD34+ cells) | IV (14), IA (6) | 12 m | Improvement in SSEP (66.7%) | None |
| Pal et al. [39] | A, C | C4-T10 | 30 | subacute to chronic | autologous BMSCs | 1 × 106 cells/kg BWT | IT | 12–36 m | No tumor formation No neurological and electrophysiologic improvements Functional improvement (16.7%; incomplete and thoracic level) |
None |
| Kumar et al. [40] | A–D | 215 paraplegia, 49 tetraplegia, 33 nontraumatic | 297 | chronic | autologous BMSCs | abour 4 × 108 cells | IT | 3 m | Neurological improvement (32.6%) | Fever (32%) Headache (23%) Tingling sensation (23%) |
| Chernykh et al. [41] | unknown | 6 paraplegia, 12 tetraplegia | 18 | chronic (36.4 ± 7.9 m) | autologous BMSCs | unknown | DI and IV | 9.4 ± 4.6 m | Neurological improvement (66.7%) | None |
|
Deda et al. [42] |
A | C3-T11 | 9 | chronic | autologous BMSCs | 2.0–6.7 × 107 cells (total) | DI, IT and IV | 12 m |
No tumor formation Neurological and electrophysiological improvements in all patients |
None |
| Cristante et al. [43] | A | paraplegia and tetraplegia | 39 | chronic (>24 m) | autologous BMSCs | 2.5 × 106 CD34+ cells/kg | IA | 30 m | Improvement in SSEP (66.7%) | None |
| Mackay-Sim et al. [44] | A | T4-10 | 6 | chronic (18 m–32 m) | autologous OECs | unknown | DI | 36 m | No change | None |
|
Lima et al. [45] |
A, B | 7 paraplegia, 13 tetraplegia (C4-T12) | 20 | chronic (18–189 m) | autologous OECs | unknown | DI | 27.7 m | No tumor or syringomyelia Neurological (55%), functional (100%, n = 13), electrophysiological (75%), and urodynamic (25%) improvements |
Aseptic meningitis (5%) Visceral pain (5%) |
| Chhabra et al. [46] | A, B | C5-T12 | 5 | chronic | autologous OECs | unknown | DI | 24 m | No neurological, electrophysiological, and urodynamic improvement Functional improvement (60–100%) |
Syrinx formation (20%) Lengthening of myelomalacia (60%) |
|
Saberi et al. [47] |
A, C | T6-9 | 4 | chronic (28–80 m) | autologous Schwann cells | 3–4.5 × 106 cells | DI | 12 m | No tumor formation Neurological improvement (25%, only patients with AIS C) |
None |
|
Knoller et al. [48] |
A? | C5-T11 | 8 | acute (≤14 d) | autologous macrophages | 4 × 106 cells | DI | 12 m | No tumor formation Neurological improvement (37.5% to AIS C) Electrophysiological improvements (62.5%) |
Anemia (100%) Fever (87.5%) |