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Effects of Therapy with Fibrin Glue combined with Mesenchymal Stem Cells (MSCs) on Bone Regeneration: A Systematic Review
Ortiz AC, Fideles SOM, Pomini KT, Reis CHB, Bueno CRS, Pereira Esbm, Rossi JO, Novais PC, Pilon JPG, Rosa Junior GM, et al
Cells. 2021;10(9)
Abstract
Cell therapy strategies using mesenchymal stem cells (MSCs) carried in fibrin glue have shown promising results in regenerative medicine. MSCs are crucial for tissue healing because they have angiogenic, anti-apoptotic and immunomodulatory properties, in addition to the ability to differentiate into several specialized cell lines. Fibrin sealant or fibrin glue is a natural polymer involved in the coagulation process. Fibrin glue provides a temporary structure that favors angiogenesis, extracellular matrix deposition and cell-matrix interactions. Additionally, fibrin glue maintains the local and paracrine functions of MSCs, providing tissue regeneration through less invasive clinical procedures. Thus, the objective of this systematic review was to assess the potential of fibrin glue combined with MSCs in bone or cartilage regeneration. The bibliographic search was performed in the PubMed/MEDLINE, LILACS and Embase databases, using the descriptors ("fibrin sealant" OR "fibrin glue") AND "stem cells" AND "bone regeneration", considering articles published until 2021. In this case, 12 preclinical and five clinical studies were selected to compose this review, according to the eligibility criteria. In preclinical studies, fibrin glue loaded with MSCs, alone or associated with bone substitute, significantly favored bone defects regeneration compared to scaffold without cells. Similarly, fibrin glue loaded with MSCs presented considerable potential to regenerate joint cartilage injuries and multiple bone fractures, with significant improvement in clinical parameters and absence of postoperative complications. Therefore, there is clear evidence in the literature that fibrin glue loaded with MSCs, alone or combined with bone substitute, is a promising strategy for treating lesions in bone or cartilaginous tissue.
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2.
The safety of modern intravenous iron infusions in patients with rheumatoid arthritis - a review of the literature
Ooi M, Hibbs S, Chen FE
Hematology (Amsterdam, Netherlands). 2020;25(1):108-111
Abstract
Objectives: To assess the evidence for the safety of intravenous iron infusions in patients with rheumatoid arthritis.Methods: A systematic literature search was performed in June 2019 on PubMed and Cochrane databases for eligible studies.Results: There is significant evidence of safety and efficacy of intravenous iron in patients with rheumatoid arthritis using newer, less immunogenic iron preparations, such as iron sucrose and low molecular weight iron dextran preparations.Discussion: Iron deficiency anaemia has a significant impact on the quality of life of patients with rheumatoid arthritis, but the use of intravenous iron is generally avoided due to concerns raisedin older studies using high molecular weight iron dextran of exacerbating the disease. However, such concerns have not been confirmed in more recent studies using newer preparations.Conclusion: We find significant evidence of safety and efficacy in more recent studies of larger cohorts of patients using newer, less immunogenic iron preparations.
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3.
The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review
Minniti MC, Statkevich AP, Kelly RL, Rigsby VP, Exline MM, Rhon DI, Clewley D
The American journal of sports medicine. 2019;:363546519882652
Abstract
BACKGROUND The effectiveness of blood flow restriction training (BFRT) as compared with other forms of training, such as resistance training, has been evaluated in the literature in clinical and nonclinical populations. However, the safety of this intervention has been summarized only in healthy populations and not in clinical populations with musculoskeletal disorders. PURPOSE To evaluate the safety and adverse events associated with BFRT in patients with musculoskeletal disorders. STUDY DESIGN Systematic review. METHODS A literature search was conducted with 3 online databases (MEDLINE, CINAHL, and Embase). Eligibility criteria for selecting studies were as follows: (1) BFRT was used as a clinical intervention, (2) study participants had a disorder of the musculoskeletal system, (3) authors addressed adverse events, (4) studies were published in English, and (5) the intervention was performed with human participants. RESULTS Nineteen studies met eligibility criteria, with a pooled sample size of 322. Diagnoses included various knee-related disorders, inclusion body myositis, polymyositis or dermatomyositis, thoracic outlet syndrome, Achilles tendon rupture, and bony fractures. Nine studies reported no adverse events, while 3 reported rare adverse events, including an upper extremity deep vein thrombosis and rhabdomyolysis. Three case studies reported common adverse events, including acute muscle pain and acute muscle fatigue. In the randomized controlled trials, individuals exposed to BFRT were not more likely to have an adverse event than individuals exposed to exercise alone. Of the 19 studies, the adverse events were as follows: overall, 14 of 322; rare overall, 3 of 322; rare BFRT, 3 of 168; rare control, 0 of 154; any adverse BFRT, 10 of 168; any adverse control, 4 of 154. A majority of studies were excluded because they did not address safety. CONCLUSION BFRT appears to be a safe strengthening approach for knee-related musculoskeletal disorders, but further research is needed to make definitive conclusions and to evaluate the safety in other musculoskeletal conditions. Improved definitions of adverse events related to BFRT are needed to include clear criteria for differentiating among common, uncommon, and rare adverse events. Finally, further research is needed to effectively screen who might be at risk for rare adverse events.
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4.
Tranexamic acid administration for anatomic and reverse total shoulder arthroplasty: a systematic review and meta-analysis
Box, H. N., Tisano, B. S., Khazzam, M.
JSES open access. 2018;2(1):28-33
Abstract
Background: Tranexamic acid (TXA) has been shown to reduce perioperative blood loss and risk of blood transfusion. Evidence establishing its efficacy in total shoulder arthroplasty (TSA) is limited. The current study evaluated the effect of TXA on perioperative blood loss and transfusion risk after TSA. Methods: A systematic review and meta-analysis of TXA administration for TSA was performed, and 6 studies with a total of 680 patients were found. Data on change in hemoglobin, drain output, total blood loss, and transfusion were extracted. Meta-analysis was performed with stratification into reverse and anatomic TSA subgroups. Results: TXA administration was associated with decreased change in hemoglobin (-0.63 g/dL; 95% CI, -0.87 to -0.39 g/dL; P < .00001), drain output (-112.05 mL; 95% CI, -182.29 to -41.81 mL; P < .0001), and total blood loss (-231.87 mL; 95% CI, -334.23 to -129.48 mL; P < .00001) after reverse TSA. There was a trend toward reduction in transfusion rate after reverse TSA (-4%; 95% CI, -8% to 0%; P = .06). TXA administration was associated with reduced drain output after anatomic TSA (-123.07 mL; 95% CI, -163.93 to -82.20 mL; P < 0.00001). TXA administration was not associated with decreased transfusion rate after anatomic TSA. Data to evaluate the effect of TXA on change in hemoglobin and total blood loss after anatomic TSA were insufficient. Conclusions: Routine administration of TXA reduces perioperative blood loss and may reduce the risk of transfusion after reverse TSA. Future studies are needed to further characterize its effect on the risk of transfusion after reverse TSA and efficacy in anatomic TSA.
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5.
Efficacy and safety of autologous blood products compared with corticosteroid injections in the treatment of lateral epicondylitis, a meta-analysis of randomized controlled trials
Qian X, Lin Q, Wei K, Hu B, Jing P, Wang J
Pm & R : the Journal of Injury, Function, and Rehabilitation. 2016;8((8):):780-91
Abstract
OBJECTIVE To compare the efficacy and safety between autologous blood products (ABPs) and corticosteroid injections (CSIs) in the treatment of lateral epicondylitis (LE). TYPE Meta-analysis. LITERATURE SURVEY We systematically searched the EMBASE, PubMed, the Cochrane Library and Web of Science to identify randomized controlled trials (RCTs) comparing ABPs versus CSIs for the treatment of LE without language and publication date restriction through April 2015. METHODOLOGY Two investigators independently included and assessed the quality of each eligible study according to the method recommended by the Cochrane Collaboration. Available data about the main outcomes were extracted from each study and heterogeneity was assessed using the Q statistic and the inconsistency index (I2). We also evaluated the publication bias and conducted a subgroup analysis. The Review Manager 5.2 software was used for data syntheses and analyses, the standardized mean difference (SMD) or mean difference (MD) were estimated by using random effects models with 95% confidence interval (CI). To investigate the efficacy among different trial durations, the follow-up times were therefore divided into short (2-4 weeks), intermediate (6-24 weeks) and long term (≥ 24 weeks). SYNTHESIS Ten RCTs (n = 509) were included in this meta-analysis. The pooled analysis showed that CSIs were more effective than ABPs on pain relief (SMD = 0.88; 95% CI = 0.31to1.46%; P = .003) in the short term. However, in the intermediate term, ABPs exhibited a better therapeutic effect for pain relief (SMD = -0.38; 95% CI = -0.70 to -0.07%; P = .02), function (SMD = -0.60; 95% CI = -1.13 to -0.08%; P = .03), DASH (MD = -11.04; 95% CI = -21.72 to -0.36%; P = .04), and Nirschl stage (MD = -0.81; 95% CI = -1.11 to -0.51%; P < .0001). In the long term, ABPs were superior to CSIs for pain relief (SMD = -0.94; 95% CI = -1.32 to -0.57%; P < .0001) and Nirschl stage (MD = -1.04; 95% CI = -1.66 to -0.42%; P = .001). Moreover, for grip strength recovery, there was no significant difference between the two therapies (p > .05). CONCLUSIONS There was limited evidence supporting the conclusion that CSIs were superior to ABPs for pain relief in the short term; however, this result was reversed in the intermediate and long term. ABPs seemed to be more effective at restoring function in the intermediate term. Due to the small sample size and the limited number of high-quality RCTs, more high-quality RCTs with large sample sizes are required to further validate this result.
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6.
Local corticosteroid versus autologous blood injections in lateral epicondylitis: meta-analysis of randomized controlled trials
Sirico F, Ricca F, Di Meglio F, Nurzynska D, Castaldo C, Spera R, Montagnani S
European Journal of Physical and Rehabilitation Medicine. 2016;53((3):):483-491.
Abstract
BACKGROUND Lateral epicondylitis is a common painful elbow disorder. Several approaches to treatment have been proposed, with a local injection of corticosteroids being the most frequently used. Recent insights into the pathophysiology encouraged the introduction of autologous blood injections as an alternative treatment method. AIM: The aim of this meta-analysis is to summarize quantitatively the evidence regarding the efficacy of corticosteroids and autologous blood injections for treatment of pain in lateral epicondylitis. DESIGN Meta-analysis. SETTING Outpatient treatment. POPULATION Studies were considered eligible based on the following inclusion criteria: adult human, diagnosis of lateral epicondylitis, randomized controlled trials comparing corticosteroids versus autologous blood injections, pain assessment. Exclusion criteria were previous surgery for lateral epicondylitis or for other elbow disorders, concurrent treatment with drugs or physiotherapy, diagnosis of musculoskeletal systemic disorder. METHODS A systematic search of literature was performed according to PRISMA statement. Effect size of each included study was calculated and analyzed in a random-effects model. RESULTS Four studies, enrolling total of 218 patients (139 females and 79 males), were included in quantitative analysis. At 2 weeks there was a trend towards a reduction of VAS score in the corticosteroid group (WMD = 2.12 [95% CI: 4.38 to 0.14], P=0.07). No significant differences were recorded in the medium-term (4-12 weeks; WMD = 0.85 [95% CI: -0.44 to 2.15], P= 0.19) and long-term (24 weeks; WMD = 0.63 [95% CI: -2.40 to 3.66], P= 0.68) follow-up. CONCLUSIONS Few high-quality trials compare the efficacy of corticosteroid and autologous blood injections in the control of pain related to lateral epicondylitis. Available data indicate that corticosteroids tend to reduce VAS score in short-term follow-up, although these data are not statistically significant. No differences were recorded in the medium and long term. CLINICAL REHABILITATION IMPACT Contrary to popular opinion among medical professionals, and despite pathophysiological cues, the currently available data offer no support for the effectiveness of autologous blood injections in medium- and long- term follow-up. Further studies are necessary to establish which treatment has more impact on pain in lateral epicondylitis. These data could be then used as a basis for practical guidelines and new protocols of treatment.
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7.
Erythropoiesis-stimulating agents for anemia in rheumatoid arthritis
Marti-Carvajal AJ, Agreda-Perez LH, Sola I, Simancas-Racines D
Cochrane Database of Systematic Reviews. 2013;2:CD000332.
Abstract
BACKGROUND Rheumatoid arthritis (RA) is a chronic and systemic inflammatory disorder that mainly affects the small joints of the hands and feet. Erythropoiesis-stimulating agents have been used to treat anemia, one of the extra-articular manifestations of RA. Although anemia is less of a problem now because of the reduction in inflammation due to disease-modifying antirheumatic drugs (DMARDs), it could still be an issue in countries where DMARDs are not yet accessible. OBJECTIVES We assessed the clinical benefits and harms of erythropoiesis-stimulating agents for anemia in rheumatoid arthritis. SEARCH METHODS We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (issue 7 2012), Ovid MEDLINE and Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations (1948 to 7 August 2012), OVID EMBASE (1980 to 7 August 2012), LILACS (1982 to 7 August 2012), the Clinical Trials Search Portal of the World Health Organization, reference lists of the retrieved publications and review articles. We did not apply any language restrictions. SELECTION CRITERIA We included randomized controlled trials (RCTs) in patients aged 16 years or over, with a diagnosis of rheumatoid arthritis affected by anemia. We considered health-related quality of life, fatigue and safety as the primary outcomes. DATA COLLECTION AND ANALYSIS Two authors independently performed trial selection, risk of bias assessment, and data extraction. We estimated difference in means with 95% confidence intervals (CIs) for continuous outcomes. We estimated risk ratios with 95% CIs for binary outcomes. MAIN RESULTS We included three RCTs with a total of 133 participants. All trials compared human recombinant erythropoietin (EPO), for different durations (8, 12 and 52 weeks), versus placebo. All RCTs assessed health-related quality of life. All trials had high or unclear risk of bias for most domains, and were sponsored by the pharmaceutical industry. Two trials administered EPO by a subcutaneous route while the other used an intravenous route.We decided not to pool results from trials, due to inconsistencies in the reporting of results.Health-related quality of life: subcutaneous EPO - one trial with 70 patients at 52 weeks showed a statistically significant difference in improvement of patient global assessment (median and interquartile range 3.5 (1.0 to 6.0) compared with placebo 4.5 (2.0 to 7.5) (P = 0.027) on a VAS scale (0 to 10)). The other shorter term trials (12 weeks with subcutaneous EPO and eight weeks with intravenous administration) did not find statistically significant differences between treatment and control groups in health-related quality of life outcomes.Change in hemoglobin: both trials of subcutaneous EPO showed a statistically significant difference in increasing hemoglobin levels; (i) at 52 weeks (one trial, 70 patients), intervention hemoglobin level (median 134, interquartile range 110 to 158 g/litre) compared with the placebo group level (median 112, interquartile range; 86 to 128 g/litre) (P = 0.0001); (ii) at 12 weeks (one trial, 24 patients) compared with placebo (difference in means 8.00, 95% CI 7.43 to 8.57). Intravenous EPO at eight weeks showed no statistically significant difference in increasing hematocrit level for EPO versus placebo (difference in means 4.69, 95% CI -0.17 to 9.55; P = 0.06).Information on withdrawals due to adverse events was not reported in two trials, and one trial found no serious adverse events leading to withdrawals. None of the trials reported withdrawals due to high blood pressure, or to lack of efficacy or to fatigue. AUTHORS' CONCLUSIONS We found conflicting evidence for erythropoiesis-stimulating agents to increase quality of life and hemoglobin level by treating anemia in patients with rheumatoid arthritis. However, this conclusion is based on randomized controlled trials with a high risk of bias, and relies on trials assessing human recombinant erythropoietin (EPO). The safety profile of EPO is unclear. Future trials assessing erythropoiesis-stimulating agents fo