Cell-Based Therapy by Autologous Bone Marrow-Derived Mononuclear Cells for Bone Augmentation of Plate-Stabilized...

Area of Science:

• Orthopedic surgery
• Regenerative medicine
• Biomaterials science

Background:

• Proximal humerus fractures are common in older adults.
• Standard surgical treatment (ORIF) has complications like dislocation and nonunion.
• Autologous bone marrow mononuclear cells (BMC) with beta-tricalcium phosphate (β-TCP) scaffolds show promise for bone healing.

Purpose of the Study:

• To evaluate if autologous BMC combined with a β-TCP scaffold reduces secondary dislocations after ORIF for proximal humerus fractures.
• To assess the safety and efficacy of this combined treatment in supporting bone healing and shoulder function.

Main Methods:

• A multicentric, randomized, open phase IIa clinical trial (NCT02803177).
• 94 patients were planned, with interim analysis at 56 patients.
• Patients received either ORIF with BMC + β-TCP (verum group) or ORIF with β-TCP only (control group).
• Outcomes measured included secondary dislocations, bone healing, DASH scores, and adverse events over 12 weeks.

Main Results:

• No statistically significant difference in secondary dislocations or complications between the BMC+β-TCP group and the control group after 12 weeks.
• Radiographic bone healing and DASH scores for shoulder function were comparable in both groups.
• Bone marrow harvest and BMC transplantation were well-tolerated, with no severe adverse events.

Conclusions:

• Autologous BMC application is safe and well-tolerated in patients undergoing ORIF for proximal humerus fractures.
• While not reducing dislocations in this study, BMC combined with β-TCP shows feasibility for augmenting bone defects and supporting bone healing.
• Further research may explore its utility in other clinical scenarios requiring bone defect augmentation.