Cellular and Clinical Analyses of Autologous Bone Marrow Aspirate Injectate for Knee Osteoarthritis: A Pilot Study

Abstract

Introduction Knee osteoarthritis (OA) is characterized by pain and functional deficits. Common conservative strategies include medications, physical therapy, and intra‐articular injections. Recently, treatment using autologous cell injections has increased. Objective To characterize the cellular content of bone marrow aspirate (BMA) and to evaluate the effect of intra‐articular autologous BMA injections in patients with mild knee OA. Design Prospective pilot observational study. Setting Academic institution. Patients Eleven patients with unilateral or bilateral mild knee OA (15 knees) were included in the cellular analysis. Ten patients (13 knees) were included in the overall (cellular and clinical) analysis. Interventions BMA was aspirated from patients’ iliac crests and then injected intra‐articularly under fluoroscopic and/or ultrasound guidance. BMA samples were analyzed using flow cytometry, colony forming unit (CFU) assays, and enzyme‐linked immunosorbent assays. Questionnaires assessing pain and function were administered preinjection and at 1, 3, 6, and 12 months postinjection. Side effects and satisfaction were assessed. Main Outcome Measures Total nucleated cell (TNC) concentration, mesenchymal stem cell (MSC) concentration, CFU count, and interleukin‐1 receptor antagonist (IL‐1Ra) concentration. Results BMA sample analyses revealed wide ranges in TNC concentration (173300‐4 491 050 cells/mL), MSC concentration (0‐500 cells/mL), CFUs (0‐19), and IL‐1Ra concentration (2806‐29 394 pg/mL). Improvements in Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement were observed throughout the 12‐month follow‐up period (F[4,12] = 12.29, P < .001). Additionally, current, usual, best, and worst numerical rating scale pain scores significantly decreased over time (P < .001). Patient satisfaction was high (range: 8.1 ± 2.1‐8.8 ± 1.9), and side effects were uncommon. Conclusions The cellular content of BMA samples varied widely between patients and was lower than the anticipated yield reported by the device's manufacturer. However, intra‐articular BMA injections for knee OA in a small pilot cohort appeared to be safe with potential therapeutic value. Larger, prospective, double‐blinded studies are warranted.

Bone Marrow Aspirate Concentrate for the Treatment of Knee Osteoarthritis: A Systematic Review

“…After anesthetization of the target site, 10,000 units/mL heparin were withdrawn into a 10-mL syringe, and after the syringe was connected to the introducer needle, heparin was injected until the introducer needle was fully rinsed and then aspirated back into the syringe. All 8 studies 2,14,28,34,39,40,43,47 described aspirating bone marrow from the posterior superior or anterior superior iliac spine. After sterile skin preparation, draping, and local anesthesia, the access needle was inserted into the medullary space, and 12 to 120 mL of BMAC was aspirated while withdrawing and rotating the needle.…”

The Current Status of Clinical Trials on Biologics for Cartilage Repair and Osteoarthritis Treatment: An Analysis of ClinicalTrials.gov Data

“…The available results of these trials indicated both BMAC and SVF were safe and therapeutic for OA applications. 20 , 21 , 54 - 57 …”

Mapping Thematic Trends and Analysing Hotspots Concerning the Use of Stem Cells for Cartilage Regeneration: A Bibliometric Analysis From 2010 to 2020

“…The effectiveness of clinical trials is a prerequisite for further clinical applications. Clinical trials focusing on the potential of stem cells in cartilage regeneration have also been carried out ( Wells et al, 2020 ). Some types of stem cells have already entered clinical trials, among which the hUCB-MSC-based therapeutic product CARTISTEM has been approved by the Korean FDA for marketing.…”