ISAKOS: 2019 Congress in Cancun, Mexico
ISAKOS

2019 ISAKOS Biennial Congress ePoster #202

 

Intra-Articular Injections of Expanded Mesenchymal Stem Cells with and without Addition of Platelet-Rich Plasma: A Randomized, Double-Blind and Controlled Clinical Trial

Ricardo P. Bastos-Filho, MD, PhD, Prof., Rio De Janeiro, RJ BRAZIL
Renato Andrade, BSc, Porto PORTUGAL
Ronaldo José F. C. Do Amaral, PhD, Dublin IRELAND
Marcelo B. Mathias, MD, Niteroi, RJ BRAZIL
Raquel C. Bastos, MD, Porto PORTUGAL
Rogério B. Pereira, BHKin, BSc, Porto PORTUGAL
Alex Balduino, PhD, Rio De Janeiro, RJ BRAZIL
Vinicius Schott-Gameiro, RJ BRAZIL
Scott A. Rodeo, MD, New York, NY UNITED STATES
João Espregueira-Mendes, MD, PhD, Porto PORTUGAL

Hospitalys, Rio de Janeiro, RJ, BRAZIL

FDA Status Not Applicable

Summary

Intra-articular injection of MSCs alone or combined with PRP is effective for the treatment of knee osteoarthritis

Abstract

Introduction

Despite of the increasing development of the novel techniques, materials and hardwares, surgical treatment of knee OA can still lead to serious complications and important comorbities. Moreover, conservative treatments are considered palliative, time limited and with poor outcomes. Intra-articular injections of human mesenchymal stromal cells (MSCs) and platelet-rich plasma (PRP) have been intensively investigated as therapies for knee osteoarthritis (OA) with positive outcomes. The purpose of the study was to assess whether the intra-articular injection of expanded MSCs in combination with PRP would be beneficial compared to expanded MSCs alone or standard corticosteroid injection.

Methods

Forty-seven patients (24 males and 23 females; 53.3 ± 10.7 years old) with radiographic symptomatic knee OA (Dejour grades II–IV) were randomized to receive intra-articular injections of MSCs (n = 16), MSCs + PRP (n = 14) or corticosteroid (n=17). Groups were homogenous at the baseline for demographics and Knee Osteoarthritis Outcome Score (KOOS) scores. MSCs were obtained after mononuclear cells separation from bone marrow aspiration collected from both posterior iliac crests using Sepax automated closed system and expanded in culture until reaching the number of 4 x 107. PRP was obtained by double-centrifugation of whole blood according to a protocol developed in house. Syringes contained MSCs, MSCs with PRP or corticosteroid were covered and the orthopaedic surgeon and patients were blinded for intra-articular injection. Variables collected were demographic characteristics, range of motion, KOOS scores, cytokines collected at pre-injection, 1, 3, 6 and 12 months after treatment. Statistical analysis performed with SPSS software and the Wilcoxon test used for comparison between baseline and final follow-up, Friedman test to compare across the several follow-up endpoints and Kruskall-Wallis test for comparing between the 3 groups.

Results

MSCs and MSCs+PRP groups showed significant mean change in all KOOS domains and global score from baseline to 12-month follow-up (p<0.05). The MSCs and MSCs+PRP groups achieved higher percentages of improvement when comparing to the corticosteroid group for the KOOS-symptoms, KOOS-pain, KOOS-function and KOOS-ADL domains and global score after 12 months follow-up. For the population equal or older than 60 years old, the MSCs+PRP group showed significant superiority for the KOOS-pain (p=0.026) and KOOS-QoL (p=0.019) domains and global score (p=0.043) at 6 months, and KOOS-ADL domain at 12 months (p=0.026). Cytokines quantification showed significant decrease of Human-IL10 cytokine (p<0.05) in all groups which evidenced the anti-inflammatory effect.

Conclusion

Intra-articular injection of MSCs alone or combined with PRP is effective for the treatment of knee OA. Adding PRP to the MSCs injection provides a greater improvement in KOOS-ADL particularly to the older population. This treatment shows promising results as a non-invasive option for conservative treatment of knee early OA.