Adipose derived mesenchymal stem cell therapy in the treatment of isolated knee chondral lesions: design of a randomised controlled pilot study comparing arthroscopic microfracture versus arthroscopic microfracture combined with postoperative mesenchymal stem cell injections

Abstract

IntroductionThe management of intra-articular chondral defects in the knee remains a challenge. Inadequate healing in areas of weight bearing leads to impairment in load transmission and these defects predispose to later development of osteoarthritis. Surgical management of full thickness chondral defects include arthroscopic microfracture and when appropriate autologous chondrocyte implantation. This latter method however is technically challenging, and may not offer significant improvement over microfracture. Preclinical and limited clinical trials have indicated the capacity of mesenchymal stem cells to influence chondral repair. The aim of this paper is to describe the methodology of a pilot randomised controlled trial comparing arthroscopic microfracture alone for isolated knee chondral defects versus arthroscopic microfracture combined with postoperative autologous adipose derived mesenchymal stem cell injections.Methods and analysisA pilot single-centre randomised controlled trial is proposed. 40 participants aged 18–50 years, with isolated femoral condyle chondral defects and awaiting planned arthroscopic microfracture will be randomly allocated to a control group (receiving no additional treatment) or treatment group (receiving postoperative adipose derived mesenchymal stem cell treatment). Primary outcome measures will include MRI assessment of cartilage volume and defects and the Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes will include further MRI assessment of bone marrow lesions, bone area and T2 cartilage mapping, a 0–10 Numerical Pain Rating Scale, a Global Impression of Change score and a treatment satisfaction scale. Adverse events and cointerventions will be recorded. Initial outcome follow-up for publication of results will be at 12 months. Further annual follow-up to assess long-term differences between the two group will occur.Ethics and disseminationThis trial has received prospective ethics approval through the Latrobe University Human Research Ethics Committee. Dissemination of outcome data is planned through both national and international conferences and formal publication in a peer-reviewed journal.Trial registration numberAustralia and New Zealand Clinical Trials Register (ANZCTR Trial ID: ACTRN12614000812695).

Experimental Application of Bone Marrow Mesenchymal Stem Cells for the Repair of Intervertebral Disc Annulus Fibrosus

“…This may be related to the anti-inflammatory and antitoxic effects of dexamethasone sodium phosphate, which slowed the disease progress to a certain extent, but did not treat the root cause of the disease [11]. In addition, as shown in Table 3, most rabbits were at grades 0 and 1 in the observation group, while at grades 4 and 5 in the control group, which is consistent with the findings of Liu et al [12]. This may be related to the strong differentiation and proliferation of BMSCs, which allows effective filling and repairing of the damaged annulus fibrosus without rejection, and thus restoring its function [13].…”

Comparative Clinical Observation of Arthroscopic Microfracture in the Presence and Absence of a Stromal Vascular Fraction Injection for Osteoarthritis

“…We believe that our study is the first to evaluate AM with and without SVF for OA treatment with an 18‐month follow‐up time. Although Freitag et al recently performed a similar study to ours, their follow‐up time was only 12 months.…”

Adipose Derived‐Mesenchymal Stem Cells Viability and Differentiating Features for Orthopaedic Reparative Applications: Banking of Adipose Tissue

“…Indeed, to date, clinical studies suggest that SVF and ATD-MSCs are safe and capable of tissue repairing [15, 18, 19, 29, 30]. Various well-defined harvesting techniques are available for liposuction procedure [27, 31, 32], even though there is not one method providing the best results in terms of viability and volume of adipose tissue with its cellular components.…”