Evidence map›Paper›PMID 31187597›Full record

Trial reportStem cells translational medicine2019

Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect on Cytokine Levels.

Neil H Riordan, Maria Luisa Hincapié, Isabela Morales, Giselle Fernández, Nicole Allen, Cindy Leu, Marialaura Madrigal, Jorge Paz Rodríguez, Nelson Novarro

Retracted Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIRetracted Publication
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cells translational medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It has been retracted, and should not be counted. It is linked to trial NCT05003960 (Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism), which is not on this map. Cited by 37 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT05003960 phase1recruitingnot on this mapstarted 2022, after this paper: background citation

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism

TypeinterventionalSponsorThe Foundation for Orthopaedics and Regenerative MedicineRan2022 to 2027Enrolled15ConditionsAutismArmsAlloRx
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
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  11. Dental Pulp Stem Cells for Salivary Gland Regeneration-Where Are We Today?International journal of molecular sciences · 2023
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Neil H RiordanMediStem Panama, Inc., City of Knowledge, Clayton, Republic of Panama.ORCID 0000-0001-5690-586X
Maria Luisa HincapiéHolistic Mind Steps, Panama, Republic of Panama.
Isabela MoralesMediStem Panama, Inc., City of Knowledge, Clayton, Republic of Panama.
Giselle FernándezStem Cell Institute, Panama, Republic of Panama.
Nicole AllenMediStem Panama, Inc., City of Knowledge, Clayton, Republic of Panama.
Cindy LeuStem Cell Institute, Panama, Republic of Panama.
Marialaura MadrigalMediStem Panama, Inc., City of Knowledge, Clayton, Republic of Panama.
Jorge Paz RodríguezStem Cell Institute, Panama, Republic of Panama.
Nelson NovarroPacífica Salud, Hospital Punta Pacífica, Panama, Republic of Panama.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Individuals with autism spectrum disorder (ASD) suffer from developmental disabilities that impact communication, behavior, and social interaction. Immune dysregulation and inflammation have been linked to children with ASD, the latter manifesting in serum levels of macrophage-derived chemokine (MDC) and thymus, and activation-regulated chemokine (TARC). Mesenchymal stem cells derived from umbilical cord tissue (UC-MSCs) have immune-modulatory and anti-inflammatory properties, and have been safely used to treat a variety of conditions. This study investigated the safety and efficacy of UC-MSCs administered to children diagnosed with ASD. Efficacy was evaluated with the Autism Treatment Evaluation Checklist (ATEC) and the Childhood Autism Rating Scale (CARS), and with measurements of MDC and TARC serum levels. Twenty subjects received a dose of 36 million intravenous UC-MSCs every 12 weeks (four times over a 9-month period), and were followed up at 3 and 12 months after treatment completion. Adverse events related to treatment were mild or moderate and short in duration. The CARS and ATEC scores of eight subjects decreased over the course of treatment, placing them in a lower ASD symptom category when compared with baseline. MDC and TARC inflammatory cytokine levels also decreased for five of these eight subjects. The mean MDC, TARC, ATEC, and CARS values attained their lowest levels 3 months after the last administration. UC-MSC administration in children with ASD was therefore determined to be safe. Although some signals of efficacy were observed in a small group of children, possible links between inflammation levels and ASD symptoms should be further investigated. Stem Cells Translational Medicine 2019;8:1008-1016.

Indexed as

AdolescentAllogeneic CellsAutism Spectrum DisorderChildCytokinesFemaleHumansMaleMesenchymal Stem CellsUmbilical CordCytokinesAutismCytokinesMesenchymal stem cellsSafetyUmbilical cord mesenchymal stem cells

Identifiers

PMID31187597
PMCPMC6766688

What OpenQuestion holds

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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.