A specific protocol of autologous bone marrow concentrate and platelet products versus exercise therapy for symptomatic knee osteoarthritis: a randomized controlled trial with 2 year follow-up

Abstract

BackgroundCell-based therapies have shown promise for the treatment of knee osteoarthritis (OA). The current study compared exercise therapy to autologous bone marrow concentrate (BMC) and platelet products for knee OA treatment.MethodsPatients with symptomatic knee OA (N = 48) were randomized into either an exercise therapy control group or treatment group with injection of autologous BMC and platelet products. Patients in the control group could crossover to BMC treatment after 3 months. Clinical outcomes were documented at baseline and at 6-weeks, 3, 6, 12 and 24 months, including the Knee Society Score (KSS), Pain Visual Analogue Scale, Short Form-12 Scales (SF-12), and Lower Extremity Activity Scale (LEAS).ResultsAll patients in the exercise group crossed over to receive BMC treatment after 3 months (N = 22 crossover). At 3 months, KSS-knee, SF-12 Physical, and LEAS improved significantly in the crossover group compared to exercise, similar to significant improvements on KSS-knee and LEAS for the treatment group (N = 26) compared to exercise group at 3 months. After BMC treatment, patients’ clinical outcome scores (except SF-12 Mental Health), were significantly improved through the 2-year follow-up compared to baseline. No serious adverse events were reported.ConclusionThe use of image-guided percutaneous BMC with platelet products yielded better results than exercise therapy as an effective alternative therapy for patients with symptomatic moderate to moderate-severe osteoarthritis of the knee.Trial registration NCT02034032. https://clinicaltrials.gov/ct2/show/NCT02034032. Registered 13 January 2014

Bone marrow concentrate injections for the treatment of osteoarthritis: evidence from preclinical findings to the clinical application

“…However, five studies were excluded being congress abstracts, one study was excluded because it was a case report [25], and one study was excluded because it provided the same data of another included study [26]. Thus, a total of 22 studies were included in the qualitative data synthesis: 4 preclinical studies [27][28][29][30] and 18 clinical studies [31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48]. Since the first reports in 2014, the publication trend remarkably increased over time, especially for the clinical studies, with over 50% of the articles published from 2018 ( Fig.…”

“…No side effects or tractable pain were detected. 27 Centeno C et al 2018 [ 35 ] Unblinded RCT Knee BMAC + platelet products vs. exercise therapy (pre-injection of dextrose, post-injection of PRP, hydrocortisone, and doxycycline after 2–4 days) Single IA injection PSIS The aspirate was processed in a sterile ISO-7 class clean room 5–7 ml injectate solution (75% of BMAC) BMAC group 26 54 years (9) Exercise group 22 57 years (8) 24 m The use of BMAC with platelet products yielded better results than exercise therapy. No serious adverse events were identified.…”

“…However, the comparative studies were not able to prove superiority over the other intra-articular options and, in the only placebo-blinded RCT [ 33 ], BMAC did not show superiority over saline at 12 months of follow-up. On the other hand, intra-articular BMAC injections (combined with platelet products) demonstrated better results than exercise therapy in knee OA patients at 24 months of follow-up [ 35 ], and subchondral BMAC injections reported similar results compared with total knee arthroplasty in younger patients with knee OA secondary to corticosteroid-related osteonecrosis at an average of 12 years of follow-up [ 36 ].…”

“…Out of the 18 clinical articles found (Table 2), six were retrospective case series, five were retrospective comparative studies, four were randomized controlled trials (RCTs), and three were prospective case series. Eleven studies focused on knee OA [31][32][33][34][35][36][37][38][39][40][41], two focused on hip OA [42,43], two focused on shoulder OA [44,45], while the other three studies described several joints affected by OA [46][47][48]. Intra-articular BMAC injections were performed in 17 studies, while in one study [36], the injection was performed within the tibial and femoral subchondral bone of the knee.…”

Bone marrow concentrate-induced mesenchymal stem cell conditioned medium facilitates wound healing and prevents hypertrophic scar formation in a rabbit ear model

“…BMC is also easy to collect, enabling immediate treatment of injuries [3]. BMC has been applied in patients with ischemic wounds, osteoporosis, arthritis, and tendon healing, yielding promising outcomes [2–6]. Although the specific mechanisms through which BMC affects wound healing have not yet been well established, several mechanisms have been proposed, including increasing tissue vascularity and tissue microperfusion at the capillary level, remodeling of fibrotic tissues to allow new capillary growth or to increase interstitial fluid flow, and modulating the inflammatory response [5].…”