Evidence map›Paper›PMID 37285522›Full record

Trial reportStem cells translational medicine2023

A Pilot Phase I Trial of Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells in Neonates With Hypoxic-Ischemic Encephalopathy.

Charles Michael Cotten, Kimberley Fisher, William Malcolm, Kathryn E Gustafson, Lynn Cheatham, Amanda Marion, Rachel Greenberg, Joanne Kurtzberg

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cells translational medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 7 pooled it
23.8field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 7 syntheses or guidelines pooled it, 44 citations in OpenAlex.

  1. Stem cell therapy in neonates with hypoxic-ischemic encephalopathy: a systematic review and meta-analysis.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2025
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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 1 institution in 1 country.

Charles Michael CottenDivision of Neonatology, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
Kimberley FisherDivision of Neonatology, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
William MalcolmDivision of Neonatology, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
Kathryn E GustafsonDepartment of Psychiatry and Behavioral Sciences, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
Lynn CheathamMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.
Amanda MarionDivision of Neonatology, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
Rachel GreenbergDivision of Neonatology, Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.
Joanne KurtzbergMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0002-3370-0703
Duke University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hypoxic ischemic encephalopathy (HIE) in neonates causes increased mortality and long-term morbidity in surviving babies. Hypothermia (HT) has improved outcomes, however, mortality remains high with ~half of surviving babies developing neurological impairment in their first years. We previously explored the use of autologous cord blood (CB) to determine if CB cells could lessen long-term damage to the brain. However, the feasibility of CB collection from sick neonates limited the utility of this approach. Allogeneic cord tissue mesenchymal stromal cells (hCT-MSC), cryopreserved and readily available, have been shown to ameliorate brain injury in animal models of HIE. We, therefore, conducted a pilot, phase I, clinical trial to test the safety and describe the preliminary efficacy of hCT-MSC in neonates with HIE. The study treated infants with moderate to severe HIE, treated with HT, with 1 or 2 doses of 2 million cells/kg/dose of hCT-MSC given intravenously. The babies were randomized to receive 1 or 2 doses with the first dose during HT and the second dose 2 months later. Babies were followed for survival and development with scoring of Bayley's at 12 postnatal months. Six neonates with moderate (4) or severe (2) HIE were enrolled. All received 1 dose of hCT-MSC during HT and 2 received a 2nd dose, 2 months later. hCT-MSC infusions were well tolerated although 5/6 babies developed low titer anti-HLA antibodies by 1 year of age. All babies survived, with average to low-average developmental assessment standard scores for ages between 12 and 17 postnatal months. Further study is warranted.

Indexed as

Hematopoietic Stem Cell TransplantationHypothermia, InducedHypoxia-Ischemia, BrainMesenchymal Stem CellsHumansInfant, NewbornUmbilical Cordcord tissueHIEhypothermiamesenchymal stromal cellsneonates

Identifiers

PMID37285522
PMCPMC10267572
OpenAlexW4379746432

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.