Preprint
Article
Evaluation of the Efficacy of Cryopreserved Human Umbilical Cord Tissue Allograft for the Supplementation of Cartilage Defects Associated to Knee Osteoarthritis: An Observational Data Collection Study
This version is not peer-reviewed.
Submitted:
20 July 2022
Posted:
22 July 2022
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Abstract
The primary objective of this study is to report the initial efficacy data observed with the use of cryopreserved human umbilical tissue allograft for the supplementation of cartilage defects in patients with symptomatic knee osteoarthritis. Our primary endpoints were pain, stiffness, and functional recovery scores. In this ongoing study, 55 participants (age 56-93 years) received a single Wharton's jelly tissue allograft application. The study dose consisted of 150mg of Wharton's jelly allograft suspended in approximately 2mL of sterile Sodium Chloride 0.9% solution (normal saline). Each study knee application was performed under ultrasound guidance in a physician's office. The research methodology consisted of NPRS scores and WOMAC subsection scores including pain, stiffness, and physical function. Study enrollment consisted of 55 patients followed for a post-application duration of 90 days. No adverse events or adverse reactions were reported. The results demonstrated statistically significant improvements of NPRS and WOMAC in initial versus 90-day examination. The data represents Wharton's jelly tissue allograft applications are a safe, non-surgical, and efficacious for patients with symptomatic articular cartilage defects associated with osteoarthritis of the knee.
Keywords:
Wharton's jelly
; Regenerative Medicine
; Osteoarthritis
; Cartilage Defects
Copyright: This open access article is published under a Creative Commons CC BY 4.0 license, which permit the free download, distribution, and reuse, provided that the author and preprint are cited in any reuse.
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