Evidence map›Paper›PMID 34362453›Full record

Trial reportStem cell research & therapy2021

Clinical and imaging outcomes after intrathecal injection of umbilical cord tissue mesenchymal stem cells in cerebral palsy: a randomized double-blind sham-controlled clinical trial.

Man Amanat, Anahita Majmaa, Morteza Zarrabi, Masoumeh Nouri, Masood Ghahvechi Akbari, Ali Reza Moaiedi, Omid Ghaemi, Fatemeh Zamani, Sharif Najafi, Reza Shervin Badv and 10 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stem cell research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03795974 (Evaluation of the Efficacy of Allogeneic Umbilical Cord Derived Hematopoietic Stem Cells and Mesenchymal Stromal Cells in Patients With Spastic Cerebral Palsy on Developmental Function , A Clinical Trial phase2), which is not on this map. Cited by 27 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 8 pooled it
6.6field-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.

NCT03795974 phase2unknown statusnot on this map

Evaluation of the Efficacy of Allogeneic Umbilical Cord Derived Hematopoietic Stem Cells and Mesenchymal Stromal Cells in Patients With Spastic Cerebral Palsy on Developmental Function , A Clinical Trial phase2

TypeinterventionalSponsorTehran University of Medical SciencesRan2017 to 2019Enrolled108ConditionsCerebral Palsy, SpasticArmsMNC, MSC, Control
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 8 syntheses or guidelines pooled it, 53 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

20 authors at 8 institutions in 2 countries.

Man AmanatDepartment of Science and Research Branch, AJA University of Medical Sciences, Tehran, Iran.
Anahita MajmaaPediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Morteza ZarrabiDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Masoumeh NouriDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Masood Ghahvechi AkbariPediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Ali Reza MoaiediDepartment of Pediatric Neurology, Clinical Research Development Center of Children Hospital, Hormozgan University of Medical Sciences, Bandar Abass, Iran.
Omid GhaemiPediatrics Center of Excellence, Department of Radiology, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Fatemeh ZamaniPediatrics Center of Excellence, Department of Radiology, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Sharif NajafiClinical Biomechanics and Ergonomics Research Center, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, AJA University of Medical Sciences, Tehran, Iran.
Reza Shervin BadvPediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Massoud VosoughDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Amir Ali HamidiehPediatrics Center of Excellence Pediatric Hematology, Oncology and Stem Cell Transplantation Department, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Mona SalehiPsychiatry and Psychology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Hadi MontazerlotfelahiDepartment of Pediatrics, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
Ali Reza TavasoliPediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Morteza HeidariPediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Hossein MohebiDepartment of Pediatric Neurology, AJA University of Medical Sciences, Tehran, Iran.
Ali FatemiMoser Center for Leukodystrophies, Kennedy Krieger Institute, Baltimore, MD, 21205, USA.
Amir GarakaniDepartment of Psychiatry, Yale School of Medicine, New Haven, CT, USA.
Mahmoud Reza AshrafiPediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran. ashrafim@tums.ac.ir.ORCID 0000-0002-8931-6743
Children's Medical Center · IRAja University of Medical Sciences · IRRoyan Institute · IRHormozgan University of Medical Sciences · IRIslamic Azad University Medical Branch of Tehran · IRKennedy Krieger Institute · USTehran University of Medical Sciences · IRYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study assessed the safety and efficacy of intrathecal injection of umbilical cord tissue mesenchymal stem cells (UCT-MSC) in individuals with cerebral palsy (CP). The diffusion tensor imaging (DTI) was performed to evaluate the alterations in white-matter integrity.

methodsParticipants (4-14 years old) with spastic CP were assigned in 1:1 ratio to receive either UCT-MSC or sham procedure. Single-dose (2 × 10

resultsThere were 36 participants in each group. The mean GMFM-66 scores after 12 months of intervention were significantly higher in the UCT-MSC group compared to baseline (10.65; 95%CI 5.39, 15.91) and control (β 8.07; 95%CI 1.62, 14.52; Cohen's d 0.92). The increase was also seen in total PEDI scores (vs baseline 8.53; 95%CI 4.98, 12.08; vs control: β 6.87; 95%CI 1.52, 12.21; Cohen's d 0.70). The mean change in MAS scores after 12 months of cell injection reduced compared to baseline (-1.0; 95%CI -1.31, -0.69) and control (β -0.72; 95%CI -1.18, -0.26; Cohen's d 0.76). Regarding CP-QoL, mean changes in domains including friends and family, participation in activities, and communication were higher than the control group with a large effect size. The DTI analysis in the experimental group showed that mean FA increased (CST 0.032; 95%CI 0.02, 0.03. PTR 0.024; 95%CI 0.020, 0.028) and MD decreased (CST -0.035 × 10

conclusionsThe UCT-MSC transplantation was safe and may improve the clinical and imaging outcomes.

trial registrationThe study was registered with ClinicalTrials.gov ( NCT03795974 ).

Indexed as

Cerebral PalsyMesenchymal Stem CellsAdolescentChildChild, PreschoolDiffusion Tensor ImagingHumansInjections, SpinalQuality of LifeUmbilical CordCerebral palsyChildrenDiffusion tensor imagingGross motor functionStem cell

Identifiers

PMID34362453
PMCPMC8343813
OpenAlexW3191543750

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.