Evidence map›Paper›PMID 32054483›Full record

ArticleJournal of orthopaedic surgery and research2020

Umbilical cord-derived Wharton's jelly for regenerative medicine applications.

Ashim Gupta, Saadiq F El-Amin, Howard J Levy, Rebecca Sze-Tu, Sobrasua E Ibim, Nicola Maffulli

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Journal of orthopaedic surgery and research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 pooled it
7.8field-weighted citation impact, top 2% 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.

NCT06415461 phase1active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 1, Open Label Dose-Ranging Study to Assess the Safety, Tolerability, Preliminary Efficacy, and Dose Effect of CFL001 Cord Blood Product in Patients With Symptomatic Sacroiliac Joint Syndrome

TypeinterventionalSponsorUniversity of FloridaRan2024 to 2028Enrolled9ConditionsSacroiliac, Backache, Pain, BackArmsPremierMaxCB®-Platinum (CFL001)
NCT06608134 early_phase1recruitingnot on this mapstarted 2024, after this paper: background citation

Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for

TypeinterventionalSponsorR3 Medical ResearchRan2024 to 2029Enrolled120ConditionsOsteoarthritis, KneeArmsUmbilical Cord Wharton's Jelly Allograft Intra-articular Knee Injection
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 100 citations in OpenAlex.

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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 6 institutions in 3 countries.

Ashim GuptaBioIntegrate, New York, NY, USA.
Saadiq F El-AminBioIntegrate, New York, NY, USA.
Howard J LevyBioIntegrate, New York, NY, USA.
Rebecca Sze-TuDepartment of Biomedical Engineering, Columbia University, New York, NY, USA.
Sobrasua E IbimMorris Brown College, Atlanta, GA, USA.
Nicola MaffulliDepartment of Musculoskeletal Disorders, School of Medicine and Surgery, University of Salerno, Fisciano, Italy. n.maffulli@qmul.ac.uk.ORCID http://orcid.org/0000-0002-5327-3702
Columbia University · USEnzo Biochem (United States) · USIllinois Wesleyan University · USMorris Brown College · USNorthwell Health · USUniversity of Salerno · IT

Funding

BioIntegrate LLC BI013/17/AG
6 · The paper itself

Abstract

backgroundThe last decade has seen an explosion in the interest in using biologics for regenerative medicine applications, including umbilical cord-derived Wharton's Jelly. There is insufficient literature assessing the amount of growth factors, cytokines, hyaluronic acid, and extracellular vesicles including exosomes in these products. The present study reports the development of a novel Wharton's jelly formulation and evaluates the presence of growth factors, cytokines, hyaluronic acid, and extracellular vesicles including exosomes.

methodsHuman umbilical cords were obtained from consenting caesarian section donors. The Wharton's jelly was then isolated from the procured umbilical cord and formulated into an injectable form. Randomly selected samples from different batches were analyzed for sterility testing and to quantify the presence of growth factors, cytokines, hyaluronic acid, and extracellular vesicles.

resultsAll samples passed the sterility test. Growth factors including IGFBP 1, 2, 3, 4, and 6, TGF-α, and PDGF-AA were detected. Several immunomodulatory cytokines, such as RANTES, IL-6R, and IL-16, were also detected. Pro-inflammatory cytokines MCSFR, MIP-1a; anti-inflammatory cytokines TNF-RI, TNF-RII, and IL-1RA; and homeostatic cytokines TIMP-1 and TIMP-2 were observed. Cytokines associated with wound healing, ICAM-1, G-CSF, GDF-15, and regenerative properties, GH, were also expressed. High concentrations of hyaluronic acid were observed. Particles in the extracellular vesicle size range were also detected and were enclosed by the membrane, indicative of true extracellular vesicles.

conclusionThere are numerous growth factors, cytokines, hyaluronic acid, and extracellular vesicles present in the Wharton's jelly formulation analyzed. The amount of these factors in Wharton's jelly is higher compared with other biologics and may play a role in reducing inflammation and pain and augment healing of musculoskeletal injuries.

Indexed as

CytokinesExtracellular MatrixFemaleHumansHyaluronic AcidInflammation MediatorsIntercellular Signaling Peptides and ProteinsPregnancyRegenerative MedicineUmbilical CordWharton JellyCytokinesHyaluronic AcidInflammation MediatorsIntercellular Signaling Peptides and ProteinsBiologicsExosomesGrowth factors, cytokinesHyaluronic acidMusculoskeletal injuriesOsteoarthritisRegenerative medicineUmbilical cordWharton’s jelly

Identifiers

PMID32054483
PMCPMC7017504
OpenAlexW3008454389

What OpenQuestion holds

Textmetadata
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.