An exploratory clinical trial for concentrated autologous bone marrow aspirate transplantation in the treatment of osteonecrosis of the femoral head.

ABSTRACT

PURPOSE: This study evaluated the efficacy and safety of a novel treatment for osteonecrosis, in which concentrated autologous bone marrow aspirate transplantation (CABMAT) is followed by low-intensity pulsed ultrasound (LIPUS) stimulation for 3 months. The study was designed as a prospective, uncontrolled, open-label phase II clinical study. METHODS: This study included 16 cases of osteonecrosis of the femoral head (ONFH), including 26 hips. Patients were transplanted with concentrated bone marrow and periodically evaluated for infection and neoplasm development. Moreover, clinical and radiological examinations were conducted to confirm the treatment efficacy. RESULTS: No infections were observed during the course of this study nor tumours developed at the treatment site 24 months after transplantation. At a mean 48 (30-56) months post-transplantation, the onset or progression of collapse was noted in four hips, of which one hip underwent total hip arthroplasty. CONCLUSION: Treatment with CABMAT combined with 3-month LIPUS stimulation was safe, and further randomised clinical studies are needed to determine the efficacy and feasibility of this treatment. TRIAL REGISTRATION UMIN Clinical Trials Registry (UMIN000020940, 9/2/2016).