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Efficacy of Ultrasound-Guided Glenohumeral Joint Injections of Leukocyte-Poor Platelet-Rich Plasma Versus Hyaluronic Acid in the Treatment of Glenohumeral Osteoarthritis: A Randomized, Double-Blind Controlled Trial

Kirschner, Jonathan S; Cheng, Jennifer; Creighton, Andrew; Santiago, Kristen; Hurwitz, Nicole; Dundas, Mark; Beatty, Nicholas; Kingsbury, Dallas; Konin, Gabrielle; Abutalib, Zafir; Chang, Richard
OBJECTIVE:To compare the efficacy of ultrasound-guided hyaluronic acid (HA) versus leukocyte-poor platelet-rich plasma (LP-PRP) injection in the treatment of glenohumeral osteoarthritis. DESIGN/METHODS:Double-blind randomized controlled trial. SETTING/METHODS:Academic institution. PATIENTS/METHODS:Seventy patients with chronic glenohumeral osteoarthritis were randomly assigned to receive a single injection of HA (n = 36) or LP-PRP (n = 34). INTERVENTIONS/METHODS:Leukocyte-poor platelet-rich plasma was processed using Harvest/TerumoBCT Clear PRP kits. Ultrasound-guided injections of 6 mL HA or 6 mL LP-PRP into the glenohumeral joint were performed. Patients, the injecting physician, and outcomes assessor were blinded to treatment assignments. MAIN OUTCOME MEASURES/METHODS:Shoulder Pain and Disability Index (SPADI), American Shoulder and Elbow Surgeons (ASES) score, current/average numerical rating scale (NRS) pain scores, satisfaction, and side effects were assessed at the 5 follow-up time points over 12 months. RESULTS:Baseline characteristics were similar between groups. There were no significant between-group differences regarding SPADI, ASES, and current/average NRS pain scores at any time point up to 12 months postinjection (P > 0.05). However, significant improvements in SPADI, ASES, and current/average NRS pain scores were observed in both groups starting at 1 or 2 months (P < 0.01, P < 0.01, P < 0.001, and P < 0.01, respectively). These improvements were observed regardless of osteoarthritis severity. For patients who received LP-PRP, there was no effect of platelet yield on outcomes. Side effect and satisfaction rates were similar between groups. CONCLUSIONS:There were no differences in pain and functional outcomes after a single injection of LP-PRP versus HA. However, significant improvements in pain and function were observed after both treatments in patients with glenohumeral osteoarthritis.
PMID: 35316820
ISSN: 1536-3724
CID: 5206652

A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants

Wang, Chang Yi; Hwang, Kao-Pin; Kuo, Hui-Kai; Peng, Wen-Jiun; Shen, Yea-Huei; Kuo, Be-Sheng; Huang, Juin-Hua; Liu, Hope; Ho, Yu-Hsin; Lin, Feng; Ding, Shuang; Liu, Zhi; Wu, Huan-Ting; Huang, Ching-Tai; Lee, Yuarn-Jang; Liu, Ming-Che; Yang, Yi-Ching; Lu, Po-Liang; Tsai, Hung-Chin; Lee, Chen-Hsiang; Shi, Zhi-Yuan; Liu, Chun-Eng; Liao, Chun-Hsing; Chang, Feng-Yee; Chen, Hsiang-Cheng; Wang, Fu-Der; Hou, Kuo-Liang; Cheng, Jennifer; Wang, Min-Sheng; Yang, Ya-Ting; Chiu, Han-Chen; Jiang, Ming-Han; Shih, Hao-Yu; Shen, Hsuan-Yu; Chang, Po-Yen; Lan, Yu-Rou; Chen, Chi-Tian; Lin, Yi-Ling; Liang, Jian-Jong; Liao, Chun-Che; Chou, Yu-Chi; Morris, Mary Kate; Hanson, Carl V; Guirakhoo, Farshad; Hellerstein, Michael; Yu, Hui-Jing; King, Chwan-Chuen; Kemp, Tracy; Heppner, D Gray; Monath, Thomas P
BackgroundThe Delta and Omicron variants of SARS-CoV-2 are currently responsible for breakthrough infections due to waning immunity. We report phase I/II trial results of UB-612, a multitope subunit vaccine containing S1-RBD-sFc protein and rationally designed promiscuous peptides representing sarbecovirus conserved helper T cell and cytotoxic T lymphocyte epitopes on the nucleocapsid (N), membrane (M), and spike (S2) proteins.MethodWe conducted a phase I primary 2-dose (28 days apart) trial of 10, 30, or 100 μg UB-612 in 60 healthy young adults 20 to 55 years old, and 50 of them were boosted with 100 μg of UB-612 approximately 7 to 9 months after the second dose. A separate placebo-controlled and randomized phase II study was conducted with 2 doses of 100 μg of UB-612 (n = 3,875, 18-85 years old). We evaluated interim safety and immunogenicity of phase I until 14 days after the third (booster) dose and of phase II until 28 days after the second dose.ResultsNo vaccine-related serious adverse events were recorded. The most common solicited adverse events were injection site pain and fatigue, mostly mild and transient. In both trials, UB-612 elicited respective neutralizing antibody titers similar to a panel of human convalescent sera. The most striking findings were long-lasting virus-neutralizing antibodies and broad T cell immunity against SARS-CoV-2 variants of concern (VoCs), including Delta and Omicron, and a strong booster-recalled memory immunity with high cross-reactive neutralizing titers against the Delta and Omicron VoCs.ConclusionUB-612 has presented a favorable safety profile, potent booster effect against VoCs, and long-lasting B and broad T cell immunity that warrants further development for both primary immunization and heterologous boosting of other COVID-19 vaccines.Trial NCT04545749, NCT04773067, and NCT04967742.FundingUBI Asia, Vaxxinity Inc., and Taiwan Centers for Disease Control, Ministry of Health and Welfare.
PMID: 35316221
ISSN: 1558-8238
CID: 5235062

A retrospective analysis of a commercially available platelet-rich plasma kit during clinical use

Prysak, Meredith H; Kyriakides, Christopher P; Zukofsky, Tyler A; Reutter, Stefan E; Cheng, Jennifer; Lutz, Gregory E
INTRODUCTION/BACKGROUND:Point-of-care analyses of platelet-rich plasma (PRP) are not routine in the orthopedic regenerative medicine field. Therefore, many physicians rely on the manufacturer's reported content for commercial preparation kits. This contributes to a knowledge gap between injectate content and patient outcome. OBJECTIVE:To assess whether the EmCyte PurePRP II 60-mL preparation kit returns PRP content that meets the manufacturer's expectations when used during routine clinical care for a heterogenous patient population, and to determine whether a change in PRP yield volume affects injectate content. Protocol A (exclusion of granulocytes and low hematocrit) and Protocol B (inclusion of granulocytes and higher hematocrit) were evaluated. DESIGN/METHODS:Retrospective review. SETTING/METHODS:Private practice. PARTICIPANTS/METHODS:One hundred five patients (118 preparations) treated for orthopedic conditions over an 8-month period via PRP injection. Thirteen patients had two independently made preparations on different treatment days that qualified for analysis. INTERVENTIONS/METHODS:Not applicable. MAIN OUTCOME MEASURES/METHODS:Complete blood count (absolute counts and calculated fold enrichment from baseline of platelets, white blood cells, red blood cells, granulocytes, lymphocytes, monocytes; and hematocrit levels). Confounding variables included age, gender, and preparation yield volume. RESULTS:During routine clinical use, the cellular content of both Protocols A and B met or exceeded the manufacturer's expectations of platelet enrichment and granulocyte inclusion or exclusion. Hematocrit values were slightly higher than anticipated from Protocol A preparations. The modification of yield volume from 7 to 4 mL led to a significant difference in platelet enrichment without affecting absolute cell counts (2.88; 95% confidence interval [CI] 1, 4.76; P = .003). Both gender and age moderately affected the level of platelet enrichment from baseline but did not significantly affect absolute platelet counts. CONCLUSION/CONCLUSIONS:In the absence of widespread characterization, confirming the variation in commercial PRP kits during clinical use is crucial.
PMID: 33543595
ISSN: 1934-1563
CID: 4861892

The effect of a postpartum diastasis rectus strengthening program [Meeting Abstract]

Toner, Lorraine E.; Casey, Ellen; Leopold, Madeline; Santiago, Kristen; Cheng, Jennifer; Keller, Leah; Abutalib, Zafir; Bonder, Jaclyn; Tenforde, Adam; Stone, Joanne; Sharma, Geeta
ISSN: 0002-9378
CID: 5298082