Yang Song1, Hui Du1, Chengxiang Dai2, Li Zhang2, Suke Li2, David J Hunter3, Liangjing Lu1, Chunde Bao1. 1. Department of Rheumatology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. 2. Cellular Biomedicine Group Ltd, Shanghai, China. 3. Rheumatology Department, Royal North Shore Hospital & Institute of Bone & Joint Research, Kolling Institute, University of Sydney, Sydney, Australia.
Abstract
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).
RCT Entities:
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).
Authors: Fangfang Xu; Yong Yang; Tao Yang; Taiqiang Dai; Xiaoxi Shao; Haiyan Xu; Ran An; Yanpu Liu; Bin Liu Journal: Am J Transl Res Date: 2018-06-15 Impact factor: 4.060