A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol

<table class="table-group" id="tab3"><tr><td><table class="table"><tr><td class="thead-hr" colspan="4"><hr/></td></tr><tr class="thead"><td class="align_left">Study arm</td><td class="align_center">Treatment</td><td class="align_center">Dosage</td><td class="align_center">Administration</td></tr><tr><td class="thead-hr" colspan="4"><hr/></td></tr><tr><td class="align_left">G1: ICA (active comparator arm)</td><td class="align_center">Iliac crest autograft</td><td class="align_center">10 cc</td><td class="align_center" rowspan="3">Local administration under surgical procedure of nonunions</td></tr><tr><td class="align_left">G2A: high dose of BM-MSC + B (experimental arm)</td><td class="align_center" rowspan="2">Expanded bone marrow mesenchymal stem cells, plus biomaterial (MBCP+)</td><td class="align_center">200 × 10<sup>6</sup> cells in 10 cc of biomaterial</td></tr><tr><td class="align_left">G2B: low dose of BM-MSC + B (experimental arm)</td><td class="align_center">100 × 10<sup>6</sup> cells in 10 cc of biomaterial</td></tr><tr class="table-tr"><td colspan="4"><hr class="tbody-hr"/></td></tr></table></td></tr></table>

<div>ORTHOUNION arms of treatment description.</div>

Stem Cells International

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Table 3

Table 3: A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol 

Table 3 | A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol 