Table 2 Clinical trials conducted using bone marrow-derived mesenchymal stem cells for the treatment of SCI
From: Treatment of spinal cord injury with mesenchymal stem cells
References | Acute, subactute or chronic | AIS grade | Number of patients | Sources of MSCs | Route of administration | Number of cells | Frequency of injection | Safety outcome | Efficacy outcome |
|---|---|---|---|---|---|---|---|---|---|
[40] | Chronic | A and B | 10 | BM | Intrathecal | 1.48 × 108 BMSCs | 3 (every 4 weeks) | No AE | Improvement in ASIA score, SEP and EMG |
[41] | Subacute and chronic | A and B | 10 | BM | Intrathecal | 1.48 × 108 BMSCs | 3 (every 4 weeks) | No AE | Long-term follow-up (30–40 months) showed that 3 patients with AIS grade B demonstrated improvement in motor power of the upper extremities, activities of daily living and positive electrophysiological changes. MRI showed reduction in cavity size and presence of fiber-like low signal intensity steaks |
[42] | Chronic | B | 16 | BM | Intrathecal | 4.8 × 107 | 1 | No AE | 2/16 patients showed improvement in motor power of the upper extremities. Study was prematurely terminated due to poor results |
[43] | Subacute | A, B and C | 5 | BM | Intrathecal | 3–5 × 107 BMSCs | 1 | No AE | Significant improvement in patients with AIS grade B and C only |
[44] | Chronic | A and B | 70 | BM | Intrathecal | 2 × 106 BMSCs/kg b.w. | 1–8 (monthly) | No AE | 17/50 patients treated with cell therapy + physiotherapy showed improvement in AIS grade. 0/20 patients received physiotherapy only exhibited changes in AIS grade |
[45] | Subacute | A | 31 | BM | Intrathecal | 7 × 105 to 1.2 × 106 BMSCs | 1 | No AE | 5/11 (45%) patients received BMSCs showed improvement in AIS grade from A to C compared to 3/20 (15%) patients in the control group |
[46] | Subacute and chronic | A and C | 30 | BM | Intrathecal | 1 × 106 BMSCs/kg b.w. | 2–3 (weekly) | No AE | No changes in AIS grade. Variable pattern of recovery in Barthel Index. No significant changes in SEP, MEP and NCV |
[47] | Chronic | A, B, C and D | 11 | BM | Intrathecal | 3 × 108 BMSCs | 3 (every 3 months) | No AE | Improvement in ASIA pin prick score, ASIA light touch score, ASIA motor score, IANR-SCIFRS score, VAS score and bladder function |
[48] | Chronic | A | 14 | BM | Intraspinal | 5 × 106 BMSCs/cm3 lesion volume | 1 | No AE | 7/12 patients showed improvement in AIS grade |
[49] | Chronic | A | 40 | BM | Intraspinal | 2 × 107 BMSCs | 1 | No AE | 9/20 patients showed improvement in AIS grade from A to B |
[50] | Chronic | A, B and C | 20 | BM | Intraspinal | 1 × 108 BMSCs | 1 | No AE | 4/8 (50%), 3/4 (75%) and 8/8 (100%) patients with AIS grade A, B and C respectively showed improvement in AIS grade |
[51] | Subacute and chronic | A, B and C | 20 | BM | Intra-arterial and intravenous | 104 ± 44.3 × 108 BMMCs | 1 | No AE | Improvement in ASIA score in patients who received the cell therapy at the subacute phase and transplantation close to the lesion site (through arteria vertebralis) |
[52] | Acute and chronic | A, B and C | 8 | BM | Intraspinal, intrathecal and intravenous | 4 × 108 BMMCs | 1 | No AE | 6/8 patients showed improvement in AIS grade. The patients also showed improvement in Frankel grade, Ashworth score and ASIA score |
[53] | Subacute | A | 1 | BM | Intrathecal, intravenous | 3.7 × 109 BMNCs & 1.54 × 108 BMSCs | 6 (every 3–4 months) | No AE | Improvement in AIS grade to C/D |
[54] | Chronic | – | 56 | BM | Intrathecal | 1 × 106 BMNCs/kg b.w. | 1 | No AE | 4 patients showed improvement in AIS grade and 24 patients have improved FIM score |