mesenchymal stromal cells implantation in combination with platelet lysate product is safe for reconstruction of human long bone non:union:

objective: non:union: is defined as a minimum of 9 months since injury without any visible progressive signs of healing for 3 months. recent literature has shown that the application of mesenchymal stromal cells is safe, in vitro and in vivo, for treating long bone non:union:. the present study was performed to investigate the safety of mesenchymal stromal cell (msc) implantation in combination with platelet lysate (pl) product for treating human long bone non:union:. materials and methods: in this case series clinical trial, orthopedic surgeons visited eighteen patients with long bone non:union:, of whom 7 complied with the eligibility criteria. these patients received mesenchymal stromal cells (20 million cells implanted once into the non:union: site using a fluoroscopic guide) in combination with pl product. for evaluation of the effects of this intervention all the patients were followed up by taking anterior-posterior and lateral x-rays of the affected limb before and 1, 3, 6, and 12 months after the implantation. all side effects (local or systemic, serious or non-serious, related or unrelated) were observed during this time period. results: from a safety perspective the msc implantation in combination with pl was very well tolerated during the 12 months of the trial. four patients were healed; based on the control x- ray evidence, bony :union: had occurred. conclusion: results from the present study suggest that the implantation of bone marrow- derived mscs in combination with pl is safe for the treatment of non:union:. a double blind, controlled clinical trial is required to assess the efficacy of this treatment (registration number: nct01206179).