Evidence map›Paper›PMID 34059080›Full record

ArticleJournal of orthopaedic surgery and research2021

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.

Ashim Gupta, Nicola Maffulli, Hugo C Rodriguez, Eric W Carson, Randa A Bascharon, Kristin Delfino, 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 NCT04711304 (A Randomized, Controlled, Single-blind, Multi-center Trial to Evaluate the Safety and Efficacy of Intraarticular Injection of Umbilical Cord Derived Wharton's Jelly Compared to Hyaluronic Acid and Saline for Knee Osteoarthritis.), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 9% 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.

NCT04711304 phase1 / phase2unknown statusnot on this mapstarted 2023, after this paper: background citation

A Randomized, Controlled, Single-blind, Multi-center Trial to Evaluate the Safety and Efficacy of Intraarticular Injection of Umbilical Cord Derived Wharton's Jelly Compared to Hyaluronic Acid and Saline for Knee Osteoarthritis.

TypeinterventionalSponsorBioIntegrateRan2023 to 2026Enrolled168ConditionsOsteoarthritis, KneeArmsUmbilical Cord-derived Wharton's Jelly, Hyaluronic acid, Saline
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  3. Clinical Applications of Extracellular Vesicles: Promises and Pitfalls.International journal of molecular sciences · 2026
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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

8 authors at 7 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.
Eric W CarsonDepartment of Orthopaedic Surgery, Washington University School of Medicine, St. Louis, MO, USA.
Randa A BascharonOrthopedic & Sports Medicine Institute of Las Vegas, Las Vegas, NV, USA.
Kristin DelfinoSouthern Illinois University, School of Medicine, Springfield, IL, 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
Las Vegas Institute · USNorthwell Health · USSouthern Illinois University School of Medicine · USThe Orthopaedic Institute · USUniversity of Salerno · ITUniversity of the Incarnate Word · USWashington University in St. Louis · US

Funding

BioIntegrate Inc. Not applicable
6 · The paper itself

Abstract

backgroundOsteoarthritis (OA) is the most common joint disorder in the United States of America (USA) with a fast-rising prevalence. Current treatment modalities are limited, and total knee replacement surgeries have shown disadvantages, especially for grade II/III OA. The interest in the use of biologics, including umbilical cord (UC)-derived Wharton's jelly (WJ), has grown in recent years. The results from a preliminary study demonstrated the presence of essential components of regenerative medicine, namely growth factors, cytokines, hyaluronic acid (HA), and extracellular vesicles, including exosomes, in WJ. The proposed study aims to evaluate the safety and efficacy of intra-articular injection of UC-derived WJ for the treatment of knee OA symptoms.

methodsA randomized, controlled, single-blind, multi-center, prospective study will be conducted in which the safety and efficacy of intra-articular administration of UC-derived WJ are compared to HA (control) and saline (placebo control) in patients suffering from grade II/III knee OA. A total of 168 participants with grade II or III knee OA on the KL scale will be recruited across 53 sites in the USA with 56 participants in each arm and followed for 1 year post-injection. Patient satisfaction, Numeric Pain Rating Scale, Knee Injury and Osteoarthritis Outcome Score, 36-Item Short Form Survey (SF-36), and 7-point Likert Scale will be used to assess the participants. Physical exams, X-rays, and MRI with Magnetic Resonance Observation of Cartilage Repair Tissue score will be used to assess improvement in associated anatomy. DISCUSSION: The study results will provide valuable information into the safety and efficacy of intra-articular administration of Wharton's jelly for grade II/III knee osteoarthritis. The results of this study will also add to the treatment options available for grade II/III OA as well as help facilitate the development of a more focused treatment strategy for patients.

trial registrationClinicalTrials.gov, NCT04711304 . Registered on January 15, 2021.

Indexed as

Umbilical CordAdolescentAdultAgedAged, 80 and overFemaleHumansHyaluronic AcidInjections, Intra-ArticularMaleMiddle AgedMulticenter Studies as TopicOsteoarthritis, KneeProspective StudiesRandomized Controlled Trials as TopicSafetyHyaluronic AcidSaline SolutionBiologicsExosomesExtracellular vesiclesGrowth factorsHyaluronic acidKnee osteoarthritisRandomized controlled trialRegenerative medicineUmbilical cordWharton’s jelly

Identifiers

PMID34059080
PMCPMC8165766
OpenAlexW3164195573

What OpenQuestion holds

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LicenceCC BY
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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.