Aim: This study aimed to evaluate the safety and therapeutic potential of autologous human adipose-derived mesenchymal stem cells (haMSCs) in patients with osteoarthritis.
Materials & methods: Safety and efficacy of haMSCs were preclinically assessed in vitro and in BALB/c-nu nude mice. 18 patients were enrolled and divided into three dose groups: the low-dose, mid-dose and high-dose group (1 × 107, 2 × 107 and 5 × 107 cells, respectively), provided three injections and followed up for 96 weeks.
Results & conclusion: The preclinical study established the safety and efficacy of haMSCs. Intra-articular injections of haMSCs were safe and improved pain, function and cartilage volume of the knee joint, rendering them a promising novel treatment for knee osteoarthritis. The dosage of 5 × 107 haMSCs exhibited the highest improvement (ClinicalTrials.gov Identifier: NCT01809769).
Keywords: MRI; MSC; cartilage; cell therapy; clinical trials; function; intra-articular; mesenchymal stem cells; osteoarthritis; pain.