Gupta, A, Maffulli, N ORCID: https://orcid.org/0000-0002-5327-3702, Rodriguez, HC, Lee, CE, Levy, HJ and El-Amin, SF (2021) Umbilical cord-derived Wharton's jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial. Journal of Orthopaedic Surgery and Research, 16 (1). 143 - ?.

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Umbilical cord-derived Whartons jelly for treatment of knee osteoarthritis study protocol for a non-randomized, open-label, .pdf - Published Version
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Abstract

BACKGROUND: Osteoarthritis (OA) is the most common joint disorder in the USA, and knee OA has the highest prevalence. Inflammation and decrease in vascularization are key factors in the degeneration of articular cartilage and the associated pain and decrease in function. To combat this process, the use of biologics including umbilical cord-derived Wharton's Jelly (UC-derived WJ) has grown. UC-derived WJ contains large quantities of regenerative factors, including growth factors (GFs), cytokines (CKs), hyaluronic acid (HA), and extracellular vesicles (EVs). The proposed study evaluates the safety and efficacy of intraarticular injection of UC-derived WJ for treatment of knee OA symptoms. METHODS AND ANALYSIS: This is a non-randomized, open-label, multi-center, prospective study in which the safety and efficacy of intraarticular UC-derived WJ in patients suffering from grade II/III OA will be assessed. Twelve patients with grade II/III OA who meet the inclusion and exclusion criteria will be recruited for this study which will be conducted at up to two sites within the USA. The participants will be followed for 1 s. Participants will be assessed using the Numeric Pain Rating Scale (NPRS), Knee Injury and Osteoarthritis Outcome Score (KOOS), 36-item short form survey (SF-36), Single Assessment Numeric Evaluation (SANE), physical exams, plain radiography, and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score for improvements in pain, satisfaction, function, and cartilage regeneration. DISCUSSION: This prospective study will contribute to the limited amount of data on UC-derived WJ, particularly with regard to its safety and efficacy. The outcomes from this study will also lay the groundwork for a large placebo-controlled trial of intraarticular UC-derived WJ for symptomatic knee OA. TRIAL REGISTRATION: ClinicalTrials.gov NCT04719793 . Registered on 22 January 2021.

Item Type: Article
Additional Information: This is the final published version (version of record). It was first published online via BioMed Central at https://doi.org/10.1186/s13018-021-02300-0 - please refer to any applicable terms of use of the publisher.
Uncontrolled Keywords: Umbilical cord, Wharton’s jelly, Knee osteoarthritis, Regenerative medicine, Biologics, Clinical trial, Extracellular vesicles, Exosomes, Growth factors, Hyaluronic acid
Subjects: R Medicine > RC Internal medicine > RC925 Diseases of the musculoskeletal system
Divisions: Faculty of Medicine and Health Sciences > School of Medicine
Related URLs:
Depositing User: Symplectic
Date Deposited: 16 Mar 2021 14:43
Last Modified: 16 Mar 2021 14:47
URI: https://eprints.keele.ac.uk/id/eprint/9260

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