Evidence map›Paper›PMID 33602286›Full record

ArticleJournal of orthopaedic surgery and research2021

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

Ashim Gupta, Nicola Maffulli, Hugo C Rodriguez, Cassidy E Lee, Howard J Levy, Saadiq F El-Amin

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Journal of orthopaedic surgery and research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04719793 (Umbilical Cord Derived Wharton's Jelly for Treatment of Knee Osteoarthritis), which is not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04719793 early_phase1unknown statusnot on this mapstarted 2023, after this paper: background citation

Umbilical Cord Derived Wharton's Jelly for Treatment of Knee Osteoarthritis

TypeinterventionalSponsorBioIntegrateRan2023 to 2024Enrolled12ConditionsOsteoarthritis, KneeArmsUmbilical Cord-derived Wharton's Jelly
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Pooled it
  2. Clinical Applications of Extracellular Vesicles: Promises and Pitfalls.International journal of molecular sciences · 2026
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  12. Exosomes from Different Sources in Promoting Wound Healing.Recent advances in drug delivery and formulation · 2025
    Review
  13. Drug delivery for age-related bone diseases: From therapeutic targets to common and emerging therapeutic strategies.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2024
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 3 countries.

Ashim GuptaBioIntegrate, Lawrenceville, GA, USA.
Nicola MaffulliDepartment of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Fisciano, Italy.
Hugo C RodriguezFuture Biologics, Lawrenceville, GA, USA.
Cassidy E LeeEl-Amin Orthopaedic and Sports Medicine Institute, 2505 Newpoint Pkwy, Suite 100B, Lawrenceville, GA, 30043, USA.
Howard J LevyBioIntegrate, Lawrenceville, GA, USA.
Saadiq F El-AminBioIntegrate, Lawrenceville, GA, USA. dr.saadiqelamin@gmail.com.ORCID http://orcid.org/0000-0001-9316-3172
Northwell Health · USThe Orthopaedic Institute · USUniversity of Salerno · ITUniversity of the Incarnate Word · USWest Los Angeles College · US

Funding

BioIntegrate Inc. Not applicable
6 · The paper itself

Abstract

backgroundOsteoarthritis (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 registrationClinicalTrials.gov NCT04719793 . Registered on 22 January 2021.

Indexed as

Osteoarthritis, KneeRegenerative MedicineUmbilical CordWharton JellyBone RegenerationCartilage, ArticularClinical Trials as TopicExtracellular VesiclesFollow-Up StudiesHumansHyaluronic AcidInjections, Intra-ArticularIntercellular Signaling Peptides and ProteinsMulticenter Studies as TopicProspective StudiesHyaluronic AcidIntercellular Signaling Peptides and ProteinsBiologicsClinical trialExosomesExtracellular vesiclesGrowth factorsHyaluronic acidKnee osteoarthritisRegenerative medicineUmbilical cordWharton’s jelly

Identifiers

PMID33602286
PMCPMC7890617
OpenAlexW3131385166

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.