Evidence map›Paper›PMID 37229431›Full record

ArticleFrontiers in neuroscience2023

Phase I trial outcome of amnion cell therapy in patients with ischemic stroke (I-ACT).

Thanh G Phan, Rebecca Lim, Siow T Chan, Hannah McDonald, Poh-Yi Gan, Shenpeng R Zhang, Liz J Barreto Arce, Jason Vuong, Tharani Thirugnanachandran, Benjamin Clissold and 8 more

Erratum issuedOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in neuroscience, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
3.5field-weighted citation impact, top 7% 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.

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

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 5 institutions in 1 country.

Thanh G PhanClinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
Rebecca LimThe Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia.
Siow T ChanThe Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia.
Hannah McDonaldThe Ritchie Centre, Hudson Institute of Medical Research, Clayton, VIC, Australia.
Poh-Yi GanDepartment of Medicine, Centre for Inflammatory Diseases, Monash Medical Centre, School of Clinical Sciences, Monash University, Clayton, VIC, Australia.
Shenpeng R ZhangDepartment of Microbiology, Anatomy, Physiology and Pharmacology, Centre for Cardiovascular Biology and Disease Research, School of Agriculture, Biomedicine and Environment, La Trobe University, Bundoora, VIC, Australia.
Liz J Barreto ArceDepartment of Microbiology, Anatomy, Physiology and Pharmacology, Centre for Cardiovascular Biology and Disease Research, School of Agriculture, Biomedicine and Environment, La Trobe University, Bundoora, VIC, Australia.
Jason VuongClinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
Tharani ThirugnanachandranClinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
Benjamin ClissoldClinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
John LyClinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
Shaloo SinghalClinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
Marie Veronic HervetClinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
Hyun Ah KimDepartment of Microbiology, Anatomy, Physiology and Pharmacology, Centre for Cardiovascular Biology and Disease Research, School of Agriculture, Biomedicine and Environment, La Trobe University, Bundoora, VIC, Australia.
Grant R DrummondDepartment of Microbiology, Anatomy, Physiology and Pharmacology, Centre for Cardiovascular Biology and Disease Research, School of Agriculture, Biomedicine and Environment, La Trobe University, Bundoora, VIC, Australia.
Euan M WallaceDepartment of Obstetrics and Gynaecology, Monash University, Clayton, VIC, Australia.
Henry MaClinical Trials, Imaging and Informatics Division, Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, VIC, Australia.
Christopher G SobeyDepartment of Microbiology, Anatomy, Physiology and Pharmacology, Centre for Cardiovascular Biology and Disease Research, School of Agriculture, Biomedicine and Environment, La Trobe University, Bundoora, VIC, Australia.
Monash University · AULa Trobe University · AUMonash Health · AUHudson Institute of Medical Research · AUMelbourne Health · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: We proposed a Phase I dose escalation trial to assess the safety of allogeneic human amniotic epithelial cells (hAECs) in stroke patients with a view to informing the design for a Phase II trial. Methods: The design is based on 3 + 3 dose escalation design with additional components for measuring MR signal of efficacy as well as the effect of hAECs (2-8 × 10 Results: Eight patients (six males) were recruited within 24 h of ischemic stroke onset and were infused with hAECs. We were able to increase the dose of hAECs to 8 × 10 Conclusion: Our Phase I trial demonstrates that a maximal dose of 2 × 10 Clinical trial registration: ClinicalTrials.gov, identifier ACTRN12618000076279P.

Indexed as

allogeneicclinical trialischemic strokephase Istem cell

Identifiers

PMID37229431
PMCPMC10204798
OpenAlexW4378349490

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.