Evidence map›Paper›PMID 24083670›Full record

Trial reportTrials2013

Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial.

Suk Jae Kim, Gyeong Joon Moon, Won Hyuk Chang, Yun-Hee Kim, Oh Young Bang, STARTING-2 (STem cell Application Researches and Trials In NeuroloGy-2) collaborators

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

Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01716481 (Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke), which is not on this map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 6% 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.

NCT01716481 phase3unknown statusnot on this map

Intravenous Administration of Autoserum-cultured Autologous Mesenchymal Stem Cells in Ischemic Stroke: A Single Center, Randomized, Open Label, Prospective, Phase 3 Study

TypeinterventionalSponsorSamsung Medical CenterRan2012 to 2017Enrolled60ConditionsStroke, IschemicArmsMesenchymal stem cell
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Stem cell transplantation for ischemic stroke.The Cochrane database of systematic reviews · 2019
    Pooled it
  2. Pooled it
  3. Article
  4. Stem cell therapy as a promising approach for ischemic stroke treatment.Current research in pharmacology and drug discovery · 2024
    Review
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  6. Article
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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

6 authors at 3 institutions in 1 country.

Suk Jae KimDepartment of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Irwon-dong, 135-710, Gangnam-gu, Seoul, South Korea. nmboy@unitel.co.kr.
Gyeong Joon Moon
Won Hyuk Chang
Yun-Hee Kim
Oh Young Bang
STARTING-2 (STem cell Application Researches and Trials In NeuroloGy-2) collaborators
Samsung Medical Center · KRSungkyunkwan University · KRSamsung (South Korea) · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRecovery after a major stroke is usually limited, but cell therapy for patients with fixed neurologic deficits is emerging. Several recent clinical trials have investigated mesenchymal stem cell (MSC) therapy for patients with ischemic stroke. We previously reported the results of a controlled trial on the application of autologous MSCs in patients with ischemic stroke with a long-term follow-up of up to 5 years (the 'STem cell Application Researches and Trials In NeuroloGy' (STARTING) study). The results from this pilot trial are challenging, but also raise important issues. In addition, there have been recent efforts to improve the safety and efficacy of MSC therapy for stroke. METHODS AND

designThe clinical and preclinical background and the STARTING-2 study protocol are provided. The trial is a prospective, randomized, open-label, blinded-endpoint (PROBE) clinical trial. Both acute and chronic stroke patients will be selected based on clinical and radiological features and followed for 3 months after MSC treatment. The subjects will be randomized into one of two groups: (A) a MSC group (n = 40) or (B) a control group (n = 20). Autologous MSCs will be intravenously administered after ex vivo culture expansion with autologous ischemic serum obtained as early as possible, to enhance the therapeutic efficacy (ischemic preconditioning). Objective outcome measurements will be performed using multimodal MRI and detailed functional assessments by blinded observers. DISCUSSION: This trial is the first to evaluate the efficacy of MSCs in patients with ischemic stroke. The results may provide better evidence for the effectiveness of MSC therapy in patients with ischemic stroke.

trial registrationThis trial was registered with ClinicalTrials.gov, number NCT01716481.

Indexed as

Research DesignAcute DiseaseCells, CulturedChronic DiseaseClinical ProtocolsHumansInfusions, IntravenousMagnetic Resonance ImagingMesenchymal Stem CellsMesenchymal Stem Cell TransplantationProspective StudiesRecovery of FunctionSerumStrokeTime FactorsTransplantation, Autologous

Identifiers

PMID24083670
PMCPMC4016561
OpenAlexW2116568124

What OpenQuestion holds

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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.