Evidence map›Paper›PMID 36563687›Full record

ReviewStem cell reports2023

Lessons learnt, and still to learn, in first in human stem cell trials.

Roger A Barker, Melissa Carpenter, Catriona H M Jamieson, Charles E Murry, Graziella Pellegrini, Rajesh C Rao, Jihwan Song

Abstract readReview
In one paragraph

Review in Stem cell reports, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

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

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
  7. Current Landscape of iPSC Haplobanks.Stem cell reviews and reports · 2024
    Review
  8. Article
  9. 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

7 authors.

Roger A BarkerDepartment of Clinical Neuroscience and Wellcome-MRC Cambridge Stem Institute, John van Geest Centre for Brain Repair, Forvie Site, Robinson Way, Cambridge CB2 0QQ, UK. Electronic address: rab46@cam.ac.uk.
Melissa CarpenterElevateBio, Cambridge, MA 02142, USA.
Catriona H M JamiesonDivision of Regenerative Medicine, Department of Medicine, Sanford Stem Cell Clinical Center, University of California San Diego, Sanford Consortium for Regenerative Medicine, 2880 Torrey Pines Scenic Drive #0695, La Jolla, CA 92037-0695, USA.
Charles E MurryInstitute for Stem Cell and Regenerative Medicine, Center for Cardiovascular Biology; Departments of Laboratory Medicine & Pathology, Bioengineering, and Medicine/Cardiology, University of Washington, Seattle, WA 98109, USA; Sana Biotechnology, Seattle, WA 98102, USA.
Graziella PellegriniCentre for Regenerative Medicine, University of Modena and Reggio Emilia, 41125 Modena, Italy.
Rajesh C RaoDepartments of Ophthalmology & Visual Sciences, Pathology, and Human Genetics, University of Michigan, Surgery Service, VA Ann Arbor Health System, Ann Arbor, MI 48105, USA.
Jihwan SongJihwan Song, Department of Biomedical Science, CHA University, 335 Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do 13488, Republic of Korea; iPS Bio, Inc., 16 Daewangpangyo-ro 712 Beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13488, Republic of Korea.

Funding

Engineered Stem Cells for Cardiac RepairR01HL128368 · NHLBI · UNIVERSITY OF WASHINGTON · PI REGNIER, MICHAEL · 2018 to 2025
$6.1M
Mechanisms of Cell-Based Heart RegenerationR01HL146868 · NHLBI · UNIVERSITY OF WASHINGTON · PI MURRY, CHARLES E, SNIADECKI, NATHAN JOHN · 2019 to 2022
$3.5M
Perfusable 3D human cardiac constructs for heart regenerationR01HL141570 · NHLBI · UNIVERSITY OF WASHINGTON · PI MURRY, CHARLES E, ZHENG, YING · 2018 to 2021
$3.3M
Metabolic and Transcriptional Reprogramming of Cardiac MaturationR01HL148081 · NHLBI · UNIVERSITY OF WASHINGTON · PI MURRY, CHARLES E · 2021 to 2024
$2.5M
Molecular Determinants for WDR5-Driven Transcriptional Regulation at Lineage-Specifying Genes During RetinogenesisR01EY030989 · NEI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI RAO, RAJESH C. · 2020 to 2024
$2.2M
Medical Research Council MC_PC_17230NEI NIH HHS R01 EY030989NHLBI NIH HHS R01 HL128368NHLBI NIH HHS R01 HL141570NHLBI NIH HHS R01 HL146868NHLBI NIH HHS R01 HL148081Wellcome Trust 203151/Z/16/Z
6 · The paper itself

Abstract

Developing cellular therapies is not straightforward. This Perspective summarizes the experience of a group of academic stem cell investigators working in different clinical areas and aims to share insight into what we wished we knew before starting. These include (1) choosing the stem cell line and assessing the genome of both the starting and final product, (2) familiarity with GMP manufacturing, reagent validation, and supply chain management, (3) product delivery issues and the additional regulatory challenges, (4) the relationship between clinical trial design and preclinical studies, and (5) the market approval requirements, pathways, and partnerships needed.

Indexed as

Cell- and Tissue-Based TherapyStem CellsCell LineHumansstem cellsstem cell therapytranslation

Identifiers

PMID36563687
PMCPMC10444539

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.