Evidence map›Paper›PMID 35351020›Full record

Trial reportBMC neurology2022

The safety and efficacy of umbilical cord blood mononuclear cells in individuals with spastic cerebral palsy: a randomized double-blind sham-controlled clinical trial.

Morteza Zarrabi, Masood Ghahvechi Akbari, Man Amanat, Anahita Majmaa, Ali Reza Moaiedi, Hadi Montazerlotfelahi, Masoumeh Nouri, Amir Ali Hamidieh, Reza Shervin Badv, Hossein Karimi and 32 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2022. 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 13 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 9% 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

13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 20 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

42 authors at 13 institutions in 2 countries.

Morteza ZarrabiDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Masood Ghahvechi AkbariPhysical Medicine and Rehabilitation Department, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Man AmanatDivision of Neurogenetics and Neuroscience, The Moser Center for Leukodystrophies, Kennedy Krieger Institute, Johns Hopkins University, Baltimore, MD, USA.
Anahita MajmaaPediatrics Center of Excellence, Pediatric Intensive Unit, Children's Medical 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 Abbas, Iran.
Hadi MontazerlotfelahiDepartment of Pediatrics, Faculty of Medicine, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
Masoumeh NouriR & D Department, Royan Stem Cell Technology Co, 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.
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.
Hossein KarimiNeurorehabilitation Research Center University of Welfare and Rehabilitation Sciences, Tehran, Iran.
Ali RabbaniPediatrics Center of Excellence Pediatric Endocrinology Department, Growth and Development Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Ali MohebbiPediatrics Center of Excellence, Growth and Development Research Center, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Shahram Rahimi-DehgolanPhysical Medicine and Rehabilitation Department, Tehran University of Medical Sciences, Tehran, Iran.
Rosa RahimiPhysical Medicine and Rehabilitation Department, Khatamolanbia Hospital, Tehran, Iran.
Ensieh DehghanTransplantation Department, Royan Stem Cell Technology Co, Tehran, Iran.
Massoud VosoughDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Saeed AbrounDepartment of Hematology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.
Farhad Mahvelati ShamsabadiDepartment of Pediatric Neurology, Atieh Hospital, 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.
Houman AlizadehPediatrics Center of Excellence, Department of Radiology, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Neda PakPediatrics Center of Excellence, Department of Radiology, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Gholam Reza ZamaniPediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Mahmoud MohammadiPediatrics Center of Excellence, Department of Pediatric Neurology, Children's Medical Center, Growth and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Mohsen JavadzadehDepartment of Pediatric Neurology, Mofid Children's Hospital, Pediatric Neurology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohammad GhofraniDepartment of Pediatric Neurology, Mofid Children's Hospital, Pediatric Neurology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Seyed Hossein HassanpourDepartment of Pediatric Neurology, Aliasghar Children's Hospital, Iran 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.
Mohammad Mehdi TaghdiriDepartment of Pediatric Neurology, Mofid Children's Hospital, Pediatric Neurology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Mohamad Javad MohseniPediatric Urology Research Center, Pediatrics Center of Excellence, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Zahra NoparastDepartment of Pediatric Nephrology, Bahrami Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Safdar MasoomiDepartment of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
Mehrdad GoudarziDepartment of Pediatric Anesthesiology, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Masood MohamadpourPediatrics Center of Excellence, Pediatric Intensive Unit, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Razieh ShodjaeeDepartment of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran.
Solaleh SamimiPhysical Medicine and Rehabilitation Department, Khatamolanbia Hospital, Tehran, Iran.
Monireh MohammadProcess Department, Royan Stem Cell Technology Co, Tehran, Iran.
Mona GholamiPhysical Medicine and Rehabilitation Department, Khatamolanbia Hospital, Tehran, Iran.
Nahid VafaeiFaculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Leyli KoochakzadehPediatrics Center of Excellence Pediatric Hematology, Department of Hematology & Oncology, Children's Medical Center, Tehran University of Medical Sciences, Tehran, Iran.
Amir ValizadehFaculty of Medicine, Students' Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Reza Azizi MalamiriDepartment of Paediatric Neurology, Golestan Medical, Educational, and Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
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.
Tehran University of Medical Sciences · IRChildren's Medical Center · IRKhatam University · IRRoyan Institute · IRShahid Beheshti University of Medical Sciences · IRAcademic Center for Education, Culture and Research · IRAhvaz Jundishapur University of Medical Sciences · IRHormozgan University of Medical Sciences · IRIran University of Medical Sciences · IRIslamic Azad University Medical Branch of Tehran · IRJohns Hopkins University · USTarbiat Modares University · IRUniversity of Social Welfare and Rehabilitation Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe current multi-center, randomized, double-blind study was conducted among children with cerebral palsy (CP) to assess the safety and efficacy of umbilical cord blood mononuclear cell (UCB-MNC). We performed the diffusion tensor imaging to assess the changes in the white matter structure.

methodsMales and females aged 4 to 14 years old with spastic CP were included. Eligible participants were allocated in 4:1 ratio to be in the experimental or control groups; respectively. Individuals who were assigned in UCB-MNC group were tested for human leukocyte antigen (HLA) and fully-matched individuals were treated with UCB-MNCs. A single dose (5 × 10

resultsThere were 72 included individuals (36 cases in each group). The mean GMFM-66 scores increased in experimental group; compared to baseline (+ 9.62; 95%CI: 6.75, 12.49) and control arm (β: 7.10; 95%CI: 2.08, 12.76; Cohen's d: 0.62) and mean MAS reduced in individuals treated with UCB-MNCs compared to the baseline (-0.87; 95%CI: -1.2, -0.54) and control group (β: -0.58; 95%CI: -1.18, -0.11; Cohen's d: 0.36). The mean PEDI scores and mean CP-QoL scores in two domains were higher in the experimental group compared to the control. The imaging data indicated that mean FA increased and MD decreased in participants of UCB-MNC group indicating improvements in white matter structure. Lower back pain, headaches, and irritability were the most common adverse events within 24 h of treatment that were related to lumbar puncture. No side effects were observed during follow-up.

conclusionsThis trial showed that intrathecal injection of UCB-MNCs were safe and effective in children with CP.

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

Indexed as

Cerebral PalsyAdolescentChildChild, PreschoolDiffusion Tensor ImagingDouble-Blind MethodFemaleFetal BloodHumansMaleQuality of LifeCerebral palsyChildrenMononuclear cellsStem cellsUmbilical cord

Identifiers

PMID35351020
PMCPMC8966246
OpenAlexW4220952574

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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.