Prospective double-blind randomised controlled trial protocol comparing bone marrow aspirate concentrate intra-articular injection combined with subchondral injection versus intra-articular injection alone for the treatment of symptomatic knee osteoarthritis

Abstract

IntroductionSubchondral and intra-articular injections of bone marrow aspirate concentrate (BMAC) showed promising results for knee osteoarthritis (OA) patients. To date, there is no evidence to demonstrate whether the combination of these treatments provides higher benefits than the intra-articular injection alone.Methods and analysisEighty-six patients with symptomatic knee OA (aged between 40 and 70 years) are randomised to BMAC intra-articular injection combined with subchondral BMAC injection or BMAC intra-articular injection alone in a ratio of 1:1. The primary outcome is the total Western Ontario and McMaster Universities Osteoarthritis Index, the secondary outcomes are the International Knee Documentation Committee Subjective and Objective Knee Evaluation Form, the Tegner activity scale, the EuroQol-Visual Analogue Scale, and the health questionnaire European Quality of Life Five Dimension score. Additional CT and MRI evaluations are performed at the baseline assessment and at the final 12-month follow-up. The hypothesis is that the combined injections provide higher knee pain and function improvement compared with BMAC intra-articular injection alone. The primary analysis follows an intention to treat principle.Ethics and disseminationThe study protocol has been approved by the Emilia Wide Area Ethical Committee of the Emilia-Romagna Region (CE-AVEC), Bologna, Italy. Written informed consent is obtained from all the participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.Protocol versionVersion 1 (14 May 2018).Trial registration numberNCT03876795.

Molecular Characterization of Secreted Factors and Extracellular Vesicles-Embedded miRNAs from Bone Marrow-Derived Mesenchymal Stromal Cells in Presence of Synovial Fluid from Osteoarthritis Patients

“…For this reason, treatments that may reduce disease manifestation in addition to slowing or stopping its progression are actively sought. In this frame, mesenchymal stromal cells (MSCs) have emerged as an attractive option, both as GMP-grade products [ 13 ] and as point-of-care products [ 14 ] such as bone marrow aspirate concentrate (BMAC) [ 15 ], micro-fragmented adipose tissue (MFAT) [ 16 ] or stromal vascular fraction (SVF) [ 17 ].…”

Short-Term Clinical Results of Single-Injection Autologous Bone Marrow Aspirate Concentrate (BMAC) as a Therapeutic Option/Tool in Knee Osteoarthritis

“…The latest studies on the usage of autologous BMAC injection in KOA showed promising and encouraging results in terms of pain reduction, improved knee range of movement, ease of life's daily activities, and, thus, improved quality of life. These results obtained with autologous BMAC are longer-lasting than other non-surgical treatments and also showed better safety profiles [15][16][17].…”

Intra-articular injection of bone marrow aspirate concentrate (mesenchymal stem cells) in KL grade III and IV knee osteoarthritis: 4 year results of 37 knees

“…Up to now only articles on BMAC injections were published with a short term follow up (6-12-24 months), regardless of the respective joint: 8,9,[15][16][17]19,[28][29][30][31][32] .…”