Treatment of osteonecrosis of the femoral head by core decompression and implantation of fully functional ex vivo-expanded bone marrow-derived mesenchymal stem cells: a proof-of-concept study

Abstract

Background

Based on several attributes involved in bone formation, bone marrow-resident mesenchymal stem cells (MSCs) have been employed in the treatment of patients suffering from femoral head osteonecrosis. Due to the low content of MSCs in the bone marrow, ex vivo expansion procedures are utilized to increase the cell number. Customarily, before administration of the resulting expanded cell product MSCs to the patient, its cellular identity is usually evaluated according to a set of “minimal phenotypic” markers, which are not modified by ex vivo processing. However, MSC functional (“reparative”) markers, which are severely impaired along the ex vivo expansion routine, are usually not assessed.

Patients and methods

In this proof-of-concept study, a cohort of five avascular osteonecrosis patients received an instillation of ex vivo-expanded autologous MSCs, manufactured under controlled conditions, with an aim to protect their functional (“reparative”) capacity.

Results and conclusion

Outcomes of this study confirmed the safety and effectiveness of the MSC-based therapy used. After a follow-up period (19–54 months), in all patients, the hip function was significantly improved and pain intensity markedly reduced. As a corollary, no patient required hip arthroplasty.

Keywords:

• avascular necrosis
• femoral head
• osteonecrosis
• mesenchymal stem cell-based therapy

Disclosure

The authors report no conflicts of interest in this work.