Efficacy of intra-articular injection of allogeneic platelet-rich plasma for knee osteoarthritis combined with hematologic blood dyscrasias with platelet dysfunction: protocol of a randomized, double-blind, placebo-controlled trial

Abstract

Background Autologous platelet-rich plasma (PRP) has been shown to alleviate the symptoms of patients suffering from knee osteoarthritis (KOA), but for certain patients with hematologic diseases with platelet dysfunction and patients receiving anti-platelet medications, autologous PRP is not an optimum solution. Allogeneic PRP has been proven to be safe and effective in the treatment of osteoarthritis, rotator cuff disease, refractory wounds and other medical fields. However, a well-designed and long-term follow-up prospective randomized controlled trial (RCT) to evaluate the effect of allogeneic PRP intra-articular injections for KOA combined with hematologic blood dyscrasias has not yet been performed. Methods/ design We will conduct an allogeneic PRP injection for KOA combined with hematologic blood dyscrasias with platelet dysfunction study: a prospective, randomized, double-blind, placebo-controlled trial. One hundred participants with KOA combined with hematologic blood dyscrasias with platelet dysfunction will be randomly allocated to receive either one allogeneic PRP injection or one saline injection into the knee joint. The primary outcome will be a 12-month change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes will be the 36-Item Short-Form General Health Survey (SF-36) score, Lysholm score, overall knee pain score and MRI assessment at 1-, 3-, 6- and 12-month. Discussion The results of this study will help determine whether allogeneic PRP could be used as a non-surgical intervention to treat patients with knee OA combined with hematologic blood dyscrasias with platelet dysfunction. Trial registration Chinese Clinical Trials Registry reference: ChiCTR2100048624. Prospectively registered 11th of July 2021.

Expanding applications of allogeneic platelets, platelet lysates, and platelet extracellular vesicles in cell therapy, regenerative medicine, and targeted drug delivery

“…The OCS is a route for exchanging biomolecules with the platelet environment, and leads to the storage of functional biomolecules, such as fibrinogen, within platelet alpha-granules [ 60 ]. The OCS also contributes to storing calcium ions, and other free ions, in platelets [ 19 ], which is vital for platelet aggregation. Furthermore, the OCS regulates p-EV release in response to platelet aggregation.…”

“…Platelet derivatives, including PRP and “platelet gels” used for regenerative medicine, are still typically obtained from autologous patient-specific blood fractions [ 81 , 82 ]. However, there is now an increasing focus on considering allogeneic (donor-derived whole blood or apheresis) PCs prepared by blood establishments and hospital blood banks as starting materials to make platelet-derived biomaterials [ 17 – 19 , 24 – 27 , 83 – 86 ]. Preparation procedures of PCs from allogeneic blood donors by blood establishments (a term equivalent to blood centers) using whole-blood donations or plateletpheresis procedures were described in previous publications [ 9 , 10 , 87 – 89 ] and are summarized below.…”

“…Objective reasons justify the interest in using allogeneic PCs to prepare platelet-derived biomaterials for translational cell therapy and regenerative medicine. First, the use of PCs from a donor represents a readily available clinical-grade therapeutic source that is highly valuable when the patients themselves are physically unable or unwilling to donate blood for their own treatment [ 17 – 19 ]. In addition, allogeneic PCs donations are available in substantially larger volumes (ca.…”

“…Several reasons contribute to the growing interest in platelet biomaterials made from allogeneic donations rather than autologous sources. First, certain patients may face challenges in donating 50–100 mL of their own blood due to various health conditions, lack of venous access, the presence of comorbidities such as thrombocytopenia (a low platelet count), platelet dysfunctions, diabetes, peripheral arterial and neuropathic disease [ 17 – 19 ], or the use of antithrombotic medications, which can impact the blood-clotting process and platelet functions [ 20 ]. Secondly, the variability in autologous platelet derivatives, affecting growth factor content and immune cell and inflammatory cytokine profile, further complicates their use [ 21 ].…”

Global trends and hotspots in the application of platelet-rich plasma in knee osteoarthritis: A bibliometric analysis from 2008 to 2022

“…[15] Since then, various scholars have extensively analyzed the composition of PRP, its application at the injection site, and the comparison of its efficacy with other drugs and its combination with other drugs. [16][17][18][19] Bibliometric analysis is a useful tool for identifying research hotspots and development potential in related fields, allowing visual analysis of authors, countries, institutions, cited literature, and keywords. [20] Currently, as the field of PRP applied to KOA research continues to expand, there is a growing consensus among researchers that PRP has better pain relief and cartilage repair compared with hyaluronic acid (HA).…”