Investigational regenerative medicine for non-traumatic osteonecrosis of the femoral head: a survey of registered clinical trials.

INTRODUCTION: Osteonecrosis of the femoral head (ONFH) is arefractory disease requiring joint replacement in young patients. Regenerativetherapies have been developed.

AREAS COVERED: This study surveyed clinical trials onregenerative medicine for ONFH. We extractedclinical trials on non-traumatic ONFH from the websites of five publiclyavailable major registries (EuropeanUnion Clinical Trials Register ([EU-CTR],ClinicalTrials.gov, Chinese ClinicalTrial Registry [ChiCTR], University Hospital Medical InformationNetwork - Clinical Trial Registry [UMIN-CTR] and Australian New Zealand Clinical Trials Registry [ANZCTR]).The trials were classified into six categories based on purpose: surgicaltreatment, non-drug conservative treatment, conservative drug treatment,therapeutic strategy, diagnosis and pathogenesis, and regenerative therapy.) We extracted 169 clinical trials on ONFH. Ofthese, 37 were on regenerativemedicine, including 29 on cell therapy. Surgicaltreatment was the most common treatment, followed by regenerative therapy.There were 9 clinical trials registered in the EU-CTR, with 5 on regenerative medicine; 79 trials registered on ClinicalTrials.gov, with 24 on regenerativemedicine; 54 trialsregistered in the ChiCTR, with 6 on regenerativemedicine.

EXPERT OPINION: The focus of the joint-preserving surgery hasshifted to regenerative therapy based on using celltherapy in early-stage ONFH. The globalstandardisation of regenerative therapy is still ongoing.