Grafting of autologous concentrated bone marrow processed using a point-of-care device for patients with osteonecrosis of the femoral head: A phase 1 feasibility and safety study.

Introduction: Along with the accumulating reports of autologous concentrated bone marrow (CBM) grafting for osteonecrosis of the femoral head (ONFH), the related medical device, a "point-of-care device" has also been recently developed. However, no study has confirmed the feasibility, safety, and efficiency of CBM grafting using a specific point-of-care device. Materials and methods: We designed this phase I, prospective clinical study to evaluate the feasibility and safety of autologous CBM grafting processed using a point-of-care device, the BioCUE system, in patients with ONFH. The primary outcomes were the safety and adverse event (AE), the secondary outcomes included pain score; hip function score; ONFH stage using X-ray; and the volume of the osteonecrotic area on 3T MRI. Besides, safety quality tests on the final product of concentrated bone marrow were performed. Results: Two patients (a 34-year-old man and a 33-year-old woman; three hips) with systemic lupus erythematosus were included. The incidence of AEs was 100% such as pain or transient fever after the operation, but all AEs were nonserious. No peri-operative complications were observed. Pain and hip function score remained unchanged from the preoperative to the postoperative observational periods. Safety quality test demonstrated were all negative or under the threshold. Conclusion: The feasibility and safety of grafting of concentrated autologous CBM in patients with ONFH using a point-of-care device were confirmed. A further clinical study aiming for the authorization of this procedure should be conducted in the future.