Table 3.
Current clinical trials.
|
ClinicalTrials.gov Identifier |
Description |
Design |
Outcomes |
| NCT0155270777 | Isolation and ex-vivo expansion of MSCs with Xcelia, then fixed to allogenic bone compared with bone iliac crest alone. | Prospective, RCT | Safety of Xcelia, feasibility of Xcelia, efficacy of spinal fusion |
| NCT0229725678 | Bone marrow aspirate concentrate (BMAC) + allograft compared with iliac crest bone graft during posterior lumbar/lumbosacral spine fusion. | Prospective, RCT | Fusion status, Oswestry Disability Index (ODI), Short Form Health Survey (SF-12), numeric pain rating scale, length of stay |
| NCT0292457179 | BMAC and allograft compared with rh-BMP2 for thoracolumbar spine fusion with interbody support. | Prospective, blinded, nonrandomized | ODI, SF-12, numeric pain rating scale |
| NCT0382709680 | Bone marrow cell aspiration from iliac crest cultivated for 3 passages to expand and suspended on β-tricalcium phosphate foam to lumbar spine. | Single group assignment | Demonstrate absence of complications at the site of spinal fusion, ODI, efficacy of spinal fusion on x-ray and CT |
| NCT0099607381 | Allogeneic mesenchymal precursor cells (NeoFuse) combined with MasterGraft Matrix compared with use of autologous iliac crest bone graft in lumbar interbody fusion site. | Prospective, multicenter, randomized | Determine safety, evaluate overall fusion success |
| NCT0109748682 | Allogeneic mesenchymal precursor cells (NeoFuse) combined with MasterGraft Matrix compared with use of autologous iliac crest bone graft in multilevel anterior cervical discectomy and fusion. | Prospective, multicenter, randomized, single-blinded | Determine safety, evaluate overall fusion success |
| NCT0207048483 | Stem cell allograft (NuCel) compared with demineralized bone matrix. | Randomized, parallel assignment | ODI, evaluation of fusion via CT |
| NCT0094198084 | Stem cells attached to allograft bone matrix (Osteocel Plus) in subjects undergoing posterior lumbar interbody fusion surgery compared with historic autograft control. | Prospective, nonrandomized multicenter | Evaluate fusion rates, complications, radiographic outcome, surgical time, blood loss |
| NCT0094883185 | Osteocel Plus in subjects undergoing anterior lumbar interbody fusion. | Prospective, nonrandomized multicenter | Evaluate fusion rates, complications, radiographic outcome, surgical time, blood loss |
| NCT0094758386 | Osteocel Plus in subjects undergoing transforaminal lumbar interbody fusion. | Prospective, nonrandomized multicenter | Evaluate fusion rates, complications, radiographic outcome, surgical time, blood loss |
| NCT0095193887 | Allogeneic cancellous bone matrix with viable osteoprogenitor cells, MSCs, and demineralized cortical bone (Trinity Evolution) in patients undergoing ACDF. | Case-only, prospective | Fusion rates, pain, complications |
Abbreviations: BMP2, bone morphogenic protein; CT, computed tomography; MSC, mesenchymal stem cell; RCT, randomized controlled trial.