Peripheral blood derived stem cells in OA knee at low resource setting: a phase II RCT

Abstract

Purpose: Osteoarthritis (OA) of the knee is one of the main causes of musculoskeletal disability. It is clinically heterogeneous, and the processes that cause deterioration are still poorly understood. Arthritis is now often considered in terms of organ failure. Because of limitations in the effectiveness of conventional management options, alternative options such as biological and regenerative methods are coming into vogue. Current research efforts are focused on the identification of key biochemical pathways that can be targeted therapeutically through biological intervention and the testing of protein bio-therapeutics for restoring the metabolic balance within the joint. In particular, the most recent knowledge regarding tissue biology highlights the potential use of specific growth factors as therapeutic proteins for cartilage repair, and this is now being widely investigated in vitro and in vivo. Nevertheless, the complex OA process involves interplay of several growth factors needed in joint homeostasis and cartilage metabolism. OA of knee is one of the most common of all musculoskeletal complaints for which reason patients seek physician consultation at PM&R department of BSMMU. This prospective clinical trial is designed to evaluate the role of peripheral blood derived stem cell therapy in the late stages of knee OA. Methods: This phase II pilot RCT is being conducted after the IRB ethical clearance memo No. bsmmu/2018/25. All the patients attending PM&R department having primary OA Knee (Kellgren-Lawrence grade III and IV) are being considered as the sample. Among them who fulfill the selection criteria are being enrolled as study subjects after obtaining informed written consent. Joint ultrasonography is be done to measure cartilage thickness for all respondents. All respondents are being divided into two groups by using randomization technique. In Control group, total 15 respondents will receive standard care for Knee Osteoarthritis and in Case group, total 15 patients will be treated with single dose autologous peripheral blood derived stem cells therapy and conventional conservatives. Stem cells are being harvested using Granulocytes Colony Stimulating Factor (G-CSF) 30MU for consecutive 05 days and CD34, CD145 stem cells are being collected through apheresis. Quality is being ensured measuring cell surface antigen. The study is expected to be completed by June 2019. Results: During this reporting period, 6 patients were enrolled in each group. The patients is being assessed at the weeks of 0, 4, 12 and 24 for pain improvement in terms of VAS and function improvement in terms of (Western Ontario and McMaster Universities Arthritis Index [WOMAC] scoring and . In addition, these patients are being followed by post-treatment ultrasonography at 3 and 6 months. Among all respondents (n=12), Female 67% Mean Age: 53±11, Grade III: 84%. After 24 weeks of stem cell therapy, pain and functional significant improvement was observed and the mean cartilage thickness increased by 0.17 mm. Conclusions: Peripheral blood derived autologous stem cells are effective to improve quality of life. More large scale research is warranted to confer it.