| Author andyear |
Study design |
No. of patients (% male) |
Cells harvested |
Outcome measured |
Summary |
| Huang et al. 2006 [13] |
Case series |
16 (88) |
Olfactory ensheathing cell (OEC) autograft.Design: Fetal olfactory mucosa grafted into cord lesion.50ulsuspension containing approx. 1×106 cells injected |
Phase I study: safety. |
Authors conclude OECs are safe in chronic SCI, conclusions limited by Phase I protocol. |
| Sykova et al., 2006 [15] |
Case series |
20(80) |
Autologous BMSC Design: Cells harvested from posterior iliac crest.Mononuclear cells isolated and infused via transfemoral catheterization of segmental arteries (n=6) or cubital veins (n=14). |
One year observation.ASIA scale, Frankel score, SSEP, MEP, MRI evaluation. |
Safety demonstrated. Improvement in motor and sensory electrophysiologic measurements was observed within 3 months in 5 of 6 patients with intra-arterial application; Overall, improvement in 5 of 7 acutely injured patients, and in 1 of 13 chronically injured. |
| Chernykh et al., 2007 [10] |
Comparative |
36 (72) |
Autologous BMSC harvested from iliac crest and engrafted to cord lesion bed in patients with chronic SCI. |
Observation time: 9.4± 4.6 months. Outcomes measurements: ASIA scale, Barthel, Ashworth score, spinal cord conduction functions, bladder control, and MRI evaluation for safety. |
Phase I study. No adverse effects notes clinically or radiographically. ASIA, Barthel, and Ashworth trend towards improvement. No observed effect on other measurements. |
| Yoon et al., 2007 [16] |
Comparative phase I/II trial |
53 (79) |
Autologous BMSC taken from iliac crest.Mononuclear cells isolated.Cells injected into 6 sites surrounding SCI lesion site.GM-CSF injected subcutaneously once/day for 5 consecutive days each month for 5 months. |
Observation: 10.1-11.3m.Outcomes: Safety, neuropathic pain, AIS grade, MRI evaluation |
Safety demonstrated.Overall 30% improvement in AIS grade. Conclusions limited by small sample size. |
| Mehta et al., 2008 [17] |
Case series |
180 (NR), 163 with SCI, 17 with indication for other neurological impairments. |
Autologous or near-relative with same blood group.Adipose tissue-derived mesenchymal cells, human embryonic stem cell-derived hematopoietic stem cells, and, autologous BM-derived stem cells.7-10ml of cells administered into subarachnoid space adjacent to injury site via lumbar puncture. |
Observation: 3m-2 years. Outcomes: Hauser Ambulation Index. |
54 of 163(33.1%) improvement in ambulation index.No tumorigenicity. Morbidity (pain, CSF hypotension and spinal headache) from technical difficulties of lumbar catheterization. |
| Saberi et al., 2008 [21] |
Case series |
33 (67) |
Autologous intramedullary Schwann cells Harvested from(15cm) sural nerve.Cells weremaintained for 3-5 weeks then injected into the injury site through a 3 cm durotomy. |
Observation: 2 years.Scales: ASIA, FIM, complications |
No significant changes.No complications attributed to procedure. |
| Cristante et al., 2009 [11] |
Case series pilot study |
39(72) |
Autologous BMSC.Subcutaneous GM-CSF administered for 5 days; day 6: peripheral blood collection via hemodialysis cathether.2.5× 106 CD34 positive cells/kg isolated.Cryopreserved and stored for 1 week. Cells delivered with arteriography cathether in right femoral artery access (10ml/min rate) |
Observation: 2.5 years. Outcomes: SSEP. |
26 patients with SSEP improvement (66%). |
| Kumar et al., 2009 [19] |
Case seriesphase I/II trial |
297 (NR) |
Autologous BMSC harvested from iliac crest.Mononuclear cells isolated by density gradient; Administered into subarachnoid space via lumbar puncture. |
Observation: 3 months.
Outcomes: Safety. Clinical sensory and motor Observation by neurological exam. |
No Adverse outcomes.Conclusions limited by Phase I design. |
| Pal et al., 2009 [9] |
Case series pilot study |
30 (NR) |
Autologous BMSC harvested from post iliac crest.Monocytes separated by density gradient.Subarachnoid cistern delivery via Lumbar puncture at or below L3. |
Observation: 1 year.
Outcomes: AIS grade, Barthel index, SSEP, MEP, NCV, MRI. |
No adverse outcomes.Unable to demonstrate improvement in outcomes measured. |
| Kishk et al., 2010 [14] |
Case-control |
44(81) |
Autologous BMSC harvested from iliac crest.Monocytes separated by density gradient.5 × 106 to 10 × 106 cells injected via lumbar puncture monthly for 6 months into lumbar cistern. |
Observation: 6 months.Outcome: Trunk muscle assessment, VAS pain, Ashworth scale, ASIA scale, AIS grade, bowel and bladder control, SSEP studies |
No statistical improvement demonstrated. One case of encephalomyelitis after third injection.23 patients developed neuropathic pain at site of injection. |
| Lima et al., 2010 [19] |
Case series phase I/II trial |
20 (85) |
Olfactory mucosa autograft.Mucosa grafted into injury site after laminectomy |
Observation: Pts followed for 2 years. Outcome: AIS grade, ASIA motor score, anal sphincter control, bladder sensation, bladder control FIM, WISCI, olfaction recovery |
Transient anosmia resolved in all patients.AIS grades improved in 11 of 20. |
| Seledtsova et al., 2010 [25] |
Case series |
43 (26) |
Fetal neurogenic tissue.Hematopoietic cells harvested from 16-22 week fetal brain and liver tissue.2-2.5×106 cells given via lumbar puncture.If intramedullary cyst present, cyst drained and cells implanted into cyst cavity.Cells readministered via lumbar puncture 10-14 days after intramedullaryimplantation for pts with cyst puncture. |
Observation: not specified.
Outcome: Clinical neurologic improvement |
Improvement in clinical exam in 48.9%. |
| Dai et al., 2013 [12] |
Case-control |
40(70) |
Autologous BMSC harvested from iliac crest.Passaged cells for 5-7 days.25ul (8× 105cells/ul) injected lesion cavity. |
Pts followed for 6 month. AIS grade, Observation: 6 months.
Outcome: ASIA motor score, EMG, paravertebral SSEP, residual urine volume |
Statistical improvement in all outcomes measures. |
| Jiang et al. 2013 [14] |
Case series |
20 (65) |
Autologous BMSC (After weekly passage for 3 weeks, 1 × 108 cells injected via lumbar puncture |
Observation: 30 days.
Outcome: ASIA scale |
Improvement in 15 patients (75%). |
BMSC: Bone Marrow-derived Stem Cells, ASIA: American Spinal Injury Association, SSEP: Somatosensory Evoked Potentials, MEP: Motor Evoked Potentials, GM-CSF:
Granulocyte Macrophage Colony-Stimulating Factor, FIM: Functional Independence Measure, NCV: nerve conduction velocity, VAS: Visual analog scale, WISCI: Walking
Index for Spinal Cord Injury