Mesenchymal Stem Cells for the Treatment of Spinal Arthrodesis: From Preclinical Research to Clinical Scenario

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	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	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	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 × 10^4/L at average (range, 1.06–1.98 × 10^4/L)	(i) Group 1: spongious allograft chips alone; (ii) Group 2: spongious allograft chips mixed with bone marrow concentrate	24 months	Completed