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Umbilical cord-derived Wharton's jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial.
Gupta, Ashim; Maffulli, Nicola; Rodriguez, Hugo C; Lee, Cassidy E; Levy, Howard J; El-Amin, Saadiq F.
Afiliación
  • Gupta A; BioIntegrate, Lawrenceville, GA, USA.
  • Maffulli N; Future Biologics, Lawrenceville, GA, USA.
  • Rodriguez HC; South Texas Orthopedic Research Institute (STORI Inc.), Laredo, TX, USA.
  • Lee CE; Veterans in Pain (V.I.P.), Los Angeles, CA, USA.
  • Levy HJ; Department of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Fisciano, Italy.
  • El-Amin SF; San Giovanni di Dio e Ruggi D'Aragona Hospital "Clinica Orthopedica" Department, Hospital of Salerno, Salerno, Italy.
J Orthop Surg Res ; 16(1): 143, 2021 Feb 18.
Article en En | MEDLINE | ID: mdl-33602286
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cordón Umbilical / Osteoartritis de la Rodilla / Medicina Regenerativa / Gelatina de Wharton Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: J Orthop Surg Res Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Cordón Umbilical / Osteoartritis de la Rodilla / Medicina Regenerativa / Gelatina de Wharton Tipo de estudio: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Humans Idioma: En Revista: J Orthop Surg Res Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido