Safety and efficacy of umbilical cord-derived Wharton’s jelly compared to hyaluronic acid and saline for knee osteoarthritis: study protocol for a randomized, controlled, single-blind, multi-center trial

Gupta, Ashim; Maffulli, Nicola; Rodriguez, Hugo C.; Carson, Eric W.; Bascharon, Randa; Delfino, Kristin; Levy, Howard J.; El-Amin, Saadiq F.

doi:10.1186/s13018-021-02475-6

Cited by 14 publications

(13 citation statements)

References 26 publications

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“…An ongoing clinical trial (ClinicalTrials.gov NCT04719793) evaluates the efficacy of umbilical cord-derived Wharton's jelly (UC-WJ) for knee OA treatment. While exosomes are present in UC-WJ, it also contains various other components, such as hyaluronic acid, cytokines, growth factors, and other EVs [167,168]. The benefits of exosomes alone, therefore, will be unknown in this clinical trial.…”

Section: Discussionmentioning

confidence: 96%

Exosomes in the Pathogenesis, Progression, and Treatment of Osteoarthritis

Fan

2022

Bioengineering

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Osteoarthritis (OA) is a prevalent and debilitating age-related joint disease characterized by articular cartilage degeneration, synovial membrane inflammation, osteophyte formation, as well as subchondral bone sclerosis. OA drugs at present are mainly palliative and do not halt or reverse disease progression. Currently, no disease-modifying OA drugs (DMOADs) are available and total joint arthroplasty remains a last resort. Therefore, there is an urgent need for the development of efficacious treatments for OA management. Among all novel pharmaco-therapeutical options, exosome-based therapeutic strategies are highly promising. Exosome cargoes, which include proteins, lipids, cytokines, and various RNA subtypes, are potentially capable of regulating intercellular communications and gene expression in target cells and tissues involved in OA development. With extensive research in recent years, exosomes in OA studies are no longer limited to classic, mesenchymal stem cell (MSC)-derived vesicles. New origins, structures, and functions of exosomes are constantly being discovered and investigated. This review systematically summarizes the non-classic origins, biosynthesis, and extraction of exosomes, describes modification and delivery techniques, explores their role in OA pathogenesis and progression, and discusses their therapeutic potential and hurdles to overcome in OA treatment.

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Section: Discussionmentioning

confidence: 96%

Exosomes in the Pathogenesis, Progression, and Treatment of Osteoarthritis

Fan

2022

Bioengineering

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“…UC-derived WJ has potential in mitigating the progression and the symptoms of OA. Larger long-term, non-randomized and randomized control trials are warranted to adequately assess the safety and efficacy of UC-derived WJ and its ultimate clinical use [ 17 , 18 ].…”

Section: Discussionmentioning

confidence: 99%

Treatment of Knee Osteoarthritis with Intraarticular Umbilical Cord-Derived Wharton’s Jelly: A Case Report

et al. 2021

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We present the case of a 27-year-old male with grade II knee osteoarthritis (OA) that was intraarticularly injected with a 2 mL umbilical cord-derived Wharton’s jelly (UC-derived WJ) formulation. The patients’ baseline radiographs were taken and baseline numeric pain rating scale (NPRS), knee injury and osteoarthritis outcome score (KOOS), 7-point Likert scale, and a 36-item short form survey (SF-36) were recorded. The NPRS was re-recorded immediately after the injection, and at 24 h, 48 h, 1 week, 6 weeks, and at 3 months follow-up post-injection. The KOOS and 7-point Likert scale was re-recorded at the patients’ 1week, 6 week, and 3month follow-up, and SF-36 was re-recorded at 3 months. A final set of X-rays were also performed at 3 months follow-up post-injection. No adverse effects from the injection were reported over the duration of the study. No significant difference nor progression in OA on X-rays compared to baseline was observed. NPRS decreased by 50% and the 7-point Likert scale increased to Extremely Satisfied. KOOS increased overall by 10% and the SF-36 overall change was 25%. These results indicate the potential application of UC-derived WJ in the treatment of knee OA. Larger, long term, non-randomized and randomized control trials are warranted to adequately assess the safety and efficacy of UC-derived WJ and ultimate clinical use.

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“…Presently, non-surgical methods for the relief of orthopaedic injuries include lifestyle changes such as exercise, diet, physical therapy, and weight loss [ 6 – 9 ]. Other treatments involve non-steroidal anti-inflammatory drugs (NSAIDs), viscosupplementation, corticosteroid injections, and opioids [ 6 , 10 – 12 ]. NSAIDs do aid the patient’s pain in the short-term, but do not address the underlying problem [ 13 ].…”

Section: Introductionmentioning

confidence: 99%

Allogenic perinatal tissue for musculoskeletal regenerative medicine applications: a systematic review protocol

et al. 2022

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Background Musculoskeletal ailments impact the lives of millions of people, and at times necessitate surgery followed by physiotherapy, drug treatments, or immobilization. Regenerative musculoskeletal medicine has undergone enormous progress over the last few decades. Sources of tissues used for regenerative medicine purposes can be grouped into autologous or allogenic. Although autologous sources are promising, there is a wide range of limitations with the treatment, including the lack of randomized controlled studies for orthopaedic conditions, donor site morbidity, and highly variable outcomes for patients. Allogenic sources bypass some of these shortcomings and are a promising source for orthopaedic regenerative medicine applications. Methods A systematic search will be performed using PubMed, Elsevier, ScienceDirect, and Google Scholar databases for articles published in English before May 2022. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and guidelines will be used. Studies will be eligible if they apply to acute and chronic orthopaedic musculoskeletal complications or animal or human disease models. Publications must include the use of MSCs and/or tissue obtained from amniotic/chorionic membrane, amniotic fluid, umbilical cord, and/or umbilical cord-derived Wharton’s jelly as an intervention. Placebos, noninjury models, acute injury models, non-injury models, and gold standard treatments will be compared. The study selection will be performed by two independent reviewers using a dedicated reference management software. Data synthesis and meta-analysis will be performed separately for preclinical and clinical studies. Discussion The results will be published in relevant peer-reviewed scientific journals. Investigators will present results at national or international conferences. Trial registration: The Protocol will be registered on PROSPERO international prospective register of systematic reviews prior to commencement.

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Safety and efficacy of umbilical cord-derived Wharton’s jelly compared to hyaluronic acid and saline for knee osteoarthritis: study protocol for a randomized, controlled, single-blind, multi-center trial

Cited by 14 publications

References 26 publications

Exosomes in the Pathogenesis, Progression, and Treatment of Osteoarthritis

Exosomes in the Pathogenesis, Progression, and Treatment of Osteoarthritis

Treatment of Knee Osteoarthritis with Intraarticular Umbilical Cord-Derived Wharton’s Jelly: A Case Report

Allogenic perinatal tissue for musculoskeletal regenerative medicine applications: a systematic review protocol

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