Evidence map›Paper›PMID 23978163›Full record

Trial reportJournal of translational medicine2013

Transplantation of human cord blood mononuclear cells and umbilical cord-derived mesenchymal stem cells in autism.

Yong-Tao Lv, Yun Zhang, Min Liu, Jia-na-ti Qiuwaxi, Paul Ashwood, Sungho Charles Cho, Ying Huan, Ru-Cun Ge, Xing-Wang Chen, Zhao-Jing Wang and 2 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of translational medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 82 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
82citing papers in PubMed, 2 pooled it
6.2field-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.

NCT01343511 phase1 / phase2completednot on this map

Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism

TypeinterventionalSponsorShenzhen Beike Bio-Technology Co., Ltd.Ran2009 to 2011Enrolled37ConditionsAutismArmshuman cord blood mononuclear cells, human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
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
NCT06415461 phase1active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 1, Open Label Dose-Ranging Study to Assess the Safety, Tolerability, Preliminary Efficacy, and Dose Effect of CFL001 Cord Blood Product in Patients With Symptomatic Sacroiliac Joint Syndrome

TypeinterventionalSponsorUniversity of FloridaRan2024 to 2028Enrolled9ConditionsSacroiliac, Backache, Pain, BackArmsPremierMaxCB®-Platinum (CFL001)
3 · Its place in the literature

Who cites it

82 citing papers in PubMed, 2 syntheses or guidelines pooled it, 170 citations in OpenAlex.

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  6. Autologous cord bloodWorld journal of clinical pediatrics · 2025
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22 more citing papers are in PubMed but not listed here.

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

12 authors at 5 institutions in 3 countries.

Yong-Tao LvShenzhen Beike Cell Engineering Research Institute, 2/F, Yuanxing Technology Building, #1 Songpingshan Street, Nanshan District, Shenzhen, Guangdong 518057, China. publication@beikebiotech.com.
Yun Zhang
Min Liu
Jia-na-ti Qiuwaxi
Paul Ashwood
Sungho Charles Cho
Ying Huan
Ru-Cun Ge
Xing-Wang Chen
Zhao-Jing Wang
Byung-Jo Kim
Xiang Hu
Shandong Jiaotong Hospital · CNBeike Biotechnology (China) · CNKorea University Medical Center · KRStanford University · USUniversity of California, Davis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAutism is a pervasive neurodevelopmental disorder. At present there are no defined mechanisms of pathogenesis and therapy is mostly limited to behavioral interventions. Stem cell transplantation may offer a unique treatment strategy for autism due to immune and neural dysregulation observed in this disease. This non-randomized, open-label, single center phase I/II trial investigated the safety and efficacy of combined transplantation of human cord blood mononuclear cells (CBMNCs) and umbilical cord-derived mesenchymal stem cells (UCMSCs) in treating children with autism.

methods37 subjects diagnosed with autism were enrolled into this study and divided into three groups: CBMNC group (14 subjects, received CBMNC transplantation and rehabilitation therapy), Combination group (9 subjects, received both CBMNC and UCMSC transplantation and rehabilitation therapy), and Control group (14 subjects, received only rehabilitation therapy). Transplantations included four stem cell infusions through intravenous and intrathecal injections once a week. Treatment safety was evaluated with laboratory examinations and clinical assessment of adverse effects. The Childhood Autism Rating Scale (CARS), Clinical Global Impression (CGI) scale and Aberrant Behavior Checklist (ABC) were adopted to assess the therapeutic efficacy at baseline (pre-treatment) and following treatment.

resultsThere were no significant safety issues related to the treatment and no observed severe adverse effects. Statistically significant differences were shown on CARS, ABC scores and CGI evaluation in the two treatment groups compared to the control at 24 weeks post-treatment (p < 0.05).

conclusionsTransplantation of CBMNCs demonstrated efficacy compared to the control group; however, the combination of CBMNCs and UCMSCs showed larger therapeutic effects than the CBMNC transplantation alone. There were no safety issues noted during infusion and the whole monitoring period.

trial registrationClinicalTrials.gov: NCT01343511, Title "Safety and Efficacy of Stem Cell Therapy in Patients with Autism".

Indexed as

Cord Blood Stem Cell TransplantationMesenchymal Stem Cell TransplantationAutistic DisorderChildChild, PreschoolFemaleHumansLeukocytes, MononuclearMaleTreatment OutcomeUmbilical Cord

Identifiers

PMID23978163
PMCPMC3765833
OpenAlexW2149113453

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.