Evidence map›Paper›PMID 39568005›Full record

Trial reportStem cell research & therapy2024

Long term outcomes of intracarotid arterial transfusion of circulatory-derived autologous CD34 + cells for acute ischemic stroke patients-A randomized, open-label, controlled phase II clinical trial.

Hung-Sheng Lin, Pei-Hsun Sung, Shu-Hua Huang, Wei-Che Lin, John Y Chiang, Ming-Chun Ma, Yi-Ling Chen, Kuan-Hung Chen, Fan-Yen Lee, Sheung-Fat Ko and 1 more

Abstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Stem cell research & therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
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

11 authors.

Hung-Sheng LinDepartment of Neurology, Cognition and Aging Center, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
Pei-Hsun SungDivision of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123, Dapi Road, Niaosung Dist., Kaohsiung City, 83301, Taiwan.
Shu-Hua HuangDepartment of Nuclear Medicine, Kaohsiung Chang Gung Memorial Hospital and, Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
Wei-Che LinDepartment of Diagnostic Radiology, Kaohsiung Chang Gung Memorial Hospital, and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
John Y ChiangDepartment of Computer Science and Engineering, National Sun Yat-Sen University, Kaohsiung, 804201, Taiwan.
Ming-Chun MaDepartment of Internal Medicine, Division of Hema-Oncology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
Yi-Ling ChenDivision of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123, Dapi Road, Niaosung Dist., Kaohsiung City, 83301, Taiwan.
Kuan-Hung ChenDepartment of Anesthesiology, Kaohsiung Chang Gung Memorial Hospital and, Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
Fan-Yen LeeDepartment of Surgery, Division of Cardiovascular Surgery, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
Sheung-Fat KoDepartment of Radiology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, 83301, Taiwan.
Hon-Kan YipDivision of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, 123, Dapi Road, Niaosung Dist., Kaohsiung City, 83301, Taiwan. han.gung@msa.hinet.net.ORCID 0000-0002-6305-5717

Funding

Ministry of Science and Technology of the Republic of China MOST 107-2314-B-182A-056-MY3
6 · The paper itself

Abstract

backgroundThis phase II randomized controlled trial tested whether the intracarotid arterial administration (ICAA) of autologous CD34 + cells to patients within 14 ± 7 days after acute ischemic stroke (IS) could be safe and further improve short- and long-term outcomes.

methodsBetween January 2018 and March 2022, 28 consecutive patients were equally randomly allocated to the cell-treated group (CD34 + cells/3.0 × 10

resultsThe results demonstrated 100% safety and success rates for the procedure, and no long-term tumorigenesis was observed in cell-treated patients. In cell-treated patients, the angiogenesis capacity of circulating endothelial progenitor cells (EPCs)/Matrigel was significantly greater after treatment than before treatment with granulocyte colony-stimulating factor (all p < 0.001). Blood samples from the right internal jugular vein of the cell-treated patients presented significantly greater levels of the stromal cell-derived factor 1α/EPC at 5, 10 and 30 min compared with 0 min (all p < 0.005). The National Institute of Health Stroke Scale scores were similar upon presentation, but a greater response was observed by Days 30 and 90 in the cell-treated group than in the control group. Tc-99 m brain perfusion was significantly greater at 180 days in the cell-treated group than in the control group (p = 0.046). The combined long-term end points (defined as death/recurrent stroke/or severe disability) were notably lower in the control group compared with the cell-treated group (14.3% vs. 50.0%, p = 0.103).

conclusionIntracarotid transfusion of autologous CD34 + cells is safe and might improve long-term outcomes in patients with acute IS. Trial registration ISRCTN, ISRCTN15677760. Registered 23 April 2018- Retrospectively registered, https://doi.org/10.1186/ISRCTN15677760.

Indexed as

Antigens, CD34Ischemic StrokeAgedEndothelial Progenitor CellsFemaleHumansMaleMiddle AgedTransplantation, AutologousTreatment OutcomeAntigens, CD34Acute ischemic strokeAngiogenesisEndothelial progenitor cellsIntracarotid transfusion of CD34 + cellsNeurological outcomes

Identifiers

PMID39568005
PMCPMC11577584

What Socratic holds

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LicenceCC BY
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.