Evidence map›Paper›PMID 35811372›Full record

Trial reportDevelopmental medicine and child neurology2022

Motor function and safety after allogeneic cord blood and cord tissue-derived mesenchymal stromal cells in cerebral palsy: An open-label, randomized trial.

Jessica M Sun, Laura E Case, Colleen McLaughlin, Alicia Burgess, Natalie Skergan, Sydney Crane, Joan M Jasien, Mohamad A Mikati, Jesse Troy, Joanne Kurtzberg

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Developmental medicine and child neurology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 5 pooled it
5.8field-weighted citation impact, top 3% 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

26 citing papers in PubMed, 5 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 1 institution in 1 country.

Jessica M SunMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0001-8085-1013
Laura E CaseDepartment of Physical and Occupational Therapy, Duke University School of Medicine, Durham, NC, USA.
Colleen McLaughlinMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.
Alicia BurgessMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.
Natalie SkerganMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.
Sydney CraneMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.
Joan M JasienDivision of Pediatric Neurology, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0002-5469-1092
Mohamad A MikatiDivision of Pediatric Neurology, Duke University School of Medicine, Durham, NC, USA.ORCID 0000-0003-0363-8715
Jesse TroyMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.
Joanne KurtzbergMarcus Center for Cellular Cures, Duke University School of Medicine, Durham, NC, USA.
Duke University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate safety and motor function after treatment with allogeneic umbilical cord blood (AlloCB) or umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy (CP).

methodNinety-one children (52 males, 39 females; median age 3 years 7 months [range 2-5 years]) with CP due to hypoxic-ischemic encephalopathy, stroke, or periventricular leukomalacia were randomized to three arms: (1) the AlloCB group received 10 × 10

resultsInfusions (n = 143) were well tolerated, with eight infusion reactions (three in the AlloCB group, five in hCT-MSC) and no other safety concerns. At 12 months, the mean differences (95% confidence intervals [CI]) between actual and expected changes in GMFM-66 score were AlloCB 5.8 points (3.4-8.2), hCT-MSC 4.3 (2.2-6.4), and natural history 3.1 (1.4-5.0). In exploratory, post hoc analysis, the mean GMFM-66 score (95% CI) of the hCT-MSC group was 1.4 points higher than natural history (-1.1 to 4.0; p = 0.27), and the AlloCB group was 3.3 points higher than natural history (0.59-5.93; p = 0.02) after adjustment for baseline Gross Motor Function Classification System level, GMFM-66 score, and etiology.

interpretationHigh-dose AlloCB is a potential cell therapy for CP and should be further tested in a randomized, blinded, placebo-controlled trial. WHAT THIS PAPER ADDS: Unrelated donor allogeneic umbilical cord blood (AlloCB) and human umbilical cord tissue-derived mesenchymal stromal cell infusion is safe in young children with cerebral palsy. Significant changes in motor function were not observed 6 months after treatment. One year later, treatment with AlloCB was associated with greater increases in Gross Motor Function Measure-66 scores.

Indexed as

Cerebral PalsyHematopoietic Stem Cell TransplantationMesenchymal Stem CellsCell- and Tissue-Based TherapyChildChild, PreschoolFemaleFetal BloodHumansInfantMale

Identifiers

PMID35811372
PMCPMC9796267
OpenAlexW4285012035

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.