Table 5.
List of clinical trials involving mesenchymal stem cells for spinal arthrodesis procedures (from clinicaltrials.gov).
| ClinicalTrials.gov Identifier | Condition | Study type | Estimated enrollment/ enrolled patients | MSC data (source, manipulation, or strategy) |
Number of cells | Study arms | Follow-up (months) | Activity |
|---|---|---|---|---|---|---|---|---|
| NCT01552707 | Degenerative spondylolisthesis grades I-II | Interventional phases 1-2 |
62 | Expanded autologous mesenchymal stem cells obtained under GMP conditions fixed in allogenic bone tissue | Not reported | (i) Group 1: instrumented spinal fusion and the tissue engineering product composed by “ex vivo” expanded autologous mesenchymal stem cells fixed in allogenic bone tissue in spinal fusion (ii) Group 2: standard treatment of instrumented spinal fusion and patient's bone iliac crest |
12 months | Recruiting |
|
| ||||||||
| NCT00549913 | Posterolateral lumbar fusion | Interventional phases 1-2 |
42 | Immunoselected, culture-expanded, nucleated, allogeneic mesenchymal progenitor cells | Not reported | (i) Experimental group 1: lowest dose of NeoFuse (ii) Experimental group 2: middle dose of NeoFuse (iii) Experimental group 3: highest dose of NeoFuse (MPCs) (iv) Control group: autologous bone graft |
24 and 36 months | Completed |
|
| ||||||||
| NCT01513694 | Intervertebral disc disease | Interventional phases 1-2 |
15 | Cell suspension of MSCs from bone marrow aspirate expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products | Not reported | (i) Autologous mesenchymal stem cells arranged in a phosphate ceramic | Not reported | Unknown |
|
| ||||||||
| NCT01603836 | Spondyloarthrosis, spondylosis | Interventional | 80 | Spongious allograft chips mixed with bone marrow concentrate | 74 × 104/L at average (range, 1.06–1.98 × 104/L) | (i) Group 1: spongious allograft chips alone (ii) Group 2: spongious allograft chips mixed with bone marrow concentrate |
24 months | Completed |