Evidence map›Paper›PMID 33246489›Full record

Trial reportStem cell research & therapy2020

Potentiation of cord blood cell therapy with erythropoietin for children with CP: a 2 × 2 factorial randomized placebo-controlled trial.

Kyunghoon Min, Mi Ri Suh, Kye Hee Cho, Wookyung Park, Myung Seo Kang, Su Jin Jang, Sang Heum Kim, Seonkyeong Rhie, Jee In Choi, Hyun-Jin Kim and 2 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, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01991145 (Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy Combined With Erythropoietin in Children With Cerebral Palsy), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
4.7field-weighted citation impact, top 4% 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.

NCT01991145 nacompletednot on this map

Safety and Efficacy of Allogeneic Umbilical Cord Blood Therapy Combined With Erythropoietin in Children With Cerebral Palsy: a Double-blind, Randomized, Placebo-controlled Clinical Trial

TypeinterventionalSponsorMinYoung Kim, MD, PhDRan2013 to 2017Enrolled92ConditionsCerebral PalsyArmsUmbilical Cord Blood therapy, Erythropoietin alfa, Rehabilitation, Placebo UCB, Placebo EPO
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 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

12 authors at 3 institutions in 2 countries.

Kyunghoon MinDepartment of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea.
Mi Ri SuhDepartment of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea.
Kye Hee ChoRehabilitation and Regeneration Research Center, CHA University, Seongnam, Republic of Korea.
Wookyung ParkDepartment of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea.
Myung Seo KangDepartment of Laboratory Medicine, CHA Bundang Medical Center, CHA University School of Medicine and CHA Cord Blood Bank, Seongnam, Republic of Korea.
Su Jin JangDepartment of Nuclear Medicine, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.
Sang Heum KimDepartment of Radiology, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.
Seonkyeong RhieDepartment of Pediatrics, CHA Bundang Medical Center, CHA University School of Medicine, Seongnam, Republic of Korea.
Jee In ChoiRehabilitation and Regeneration Research Center, CHA University, Seongnam, Republic of Korea.
Hyun-Jin KimRehabilitation and Regeneration Research Center, CHA University, Seongnam, Republic of Korea.
Kwang Yul ChaCHA Hollywood Presbyterian Medical Center, Los Angeles, CA, USA.
MinYoung KimDepartment of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine, 59 Yatap-ro, Bundang-gu, Seongnam, Gyeonggi-do, Republic of Korea. kmin@cha.ac.kr.ORCID 0000-0001-5481-2985
CHA University Bundang Medical Center · KRCHA University · KRTexas Health Dallas · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundConcomitant administration of allogeneic umbilical cord blood (UCB) infusion and erythropoietin (EPO) showed therapeutic efficacy in children with cerebral palsy (CP). However, no clinical studies have investigated the effects of UCB and EPO combination therapy using a 2 × 2 four-arm factorial blinded design with four arms. This randomized placebo-controlled trial aimed to identify the synergistic and individual efficacies of UCB cell and EPO for the treatment of CP.

methodsChildren diagnosed with CP were randomly segregated into four groups: (A) UCB+EPO, (B) UCB+placebo EPO, (C) placebo UCB+EPO, and (D) placebo UCB+placebo EPO. Based on the UCB unit selection criteria of matching for ≥ 4/6 of human leukocyte antigen (HLA)-A, -B, and DRB1 and total nucleated cell (TNC) number of ≥ 3 × 10

resultsEighty-eight of 92 children enrolled (3.05 ± 1.22 years) completed the study. Change in gross motor performance measure (GMPM) was greater in group A than in group D at 1 month (△2.30 vs. △0.71, P = 0.025) and 12 months (△6.85 vs. △2.34, P = 0.018) post-treatment. GMPM change ratios were calculated to adjust motor function at the baseline. Group A showed a larger improvement in the GMPM change ratio at 1 month and 12 months post-treatment than group D. At 12 months post-treatment, the GMPM change ratios were in the order of groups A, B, C, and D. These results indicate synergistic effect of UCB and EPO combination better than each single therapy. In diffusion tensor imaging, the change ratio of fractional anisotropy at spinothalamic radiation was higher in group A than group D in subgroup of age ≥ 3 years. Additionally, higher TNC and more HLA-matched UCB units led to better gross motor outcomes in group A. Adverse events remained unchanged upon UCB or EPO administration.

conclusionsThese results indicate that the efficacy of allogeneic UCB cell could be potentiated by EPO for neurological recovery in children with CP without harmful effects.

trial registrationClinicalTrials.gov, NCT01991145 , registered 25 November 2013.

Indexed as

Cerebral PalsyErythropoietinCell- and Tissue-Based TherapyChildChild, PreschoolDiffusion Tensor ImagingFetal BloodHumansErythropoietinCerebral palsyClinical trialErythropoietinFunctional performanceUmbilical cord blood

Identifiers

PMID33246489
PMCPMC7694426
OpenAlexW3107151718

What Socratic 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 Socratic graph.