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Clinical Trial
. 2021 Feb 18;16(1):143.
doi: 10.1186/s13018-021-02300-0.

Umbilical cord-derived Wharton's jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial

Ashim Gupta  1   2   3   4 , Nicola Maffulli  5   6   7   8 , Hugo C Rodriguez  2   3   9   10 , Cassidy E Lee  11 , Howard J Levy  1   12 , Saadiq F El-Amin 3rd  13   14
Affiliations
Clinical Trial

Umbilical cord-derived Wharton's jelly for treatment of knee osteoarthritis: study protocol for a non-randomized, open-label, multi-center trial

Ashim Gupta et al. J Orthop Surg Res. .

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.

Keywords: Biologics; Clinical trial; Exosomes; Extracellular vesicles; Growth factors; Hyaluronic acid; Knee osteoarthritis; Regenerative medicine; Umbilical cord; Wharton’s jelly.

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Conflict of interest statement

AG is a consultant for BioIntegrate. HJL and SFE own equity in BioIntegrate. The remaining authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Summary of trial design
Fig. 2
Fig. 2
Standard protocol items: recommendations for interventional trials (SPIRIT) flowchart
See this image and copyright information in PMC

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