Evidence map›Paper›PMID 37487631›Full record

ReviewCold Spring Harbor perspectives in medicine2024

Considerations for Developing an Autologous Induced Pluripotent Stem Cell (iPSC)-Derived Retinal Pigment Epithelium (RPE) Replacement Therapy.

Devika Bose, Davide Ortolan, Mitra Farnoodian, Ruchi Sharma, Kapil Bharti

Open access · bronzeAbstract readReview
In one paragraph

Review in Cold Spring Harbor perspectives in medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
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

5 authors at 1 institution in 1 country.

Devika BoseOcular and Stem Cell Translational Research, National Eye Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.
Davide OrtolanOcular and Stem Cell Translational Research, National Eye Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.
Mitra FarnoodianOcular and Stem Cell Translational Research, National Eye Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.
Ruchi SharmaOcular and Stem Cell Translational Research, National Eye Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.
Kapil BhartiOcular and Stem Cell Translational Research, National Eye Institute, National Institutes of Health, Bethesda, Maryland 20892, USA Kapil.bharti@nih.gov.
National Institutes of Health · US

Funding

Developing autologous iPSC-RPE based IND for AMD patientsZIAEY000542 · NEI · NATIONAL EYE INSTITUTE · PI BHARTI, KAPIL · 2014 to 2025
$24.2M
Flow Cytometry COREZICEY000457 · NEI · NATIONAL EYE INSTITUTE · PI CASPI, RACHEL R. · 2009 to 2025
$5.9M
6 · The paper itself

Abstract

Cell-replacement therapies are a new class of treatments, which include induced pluripotent stem cell (iPSC)-derived tissues that aim to replace degenerated cells. iPSCs can potentially be used to generate any cell type of the body, making them a powerful tool for treating degenerative diseases. Cell replacement for retinal degenerative diseases is at the forefront of cell therapies, given the accessibility of the eye for surgical procedures and a huge unmet medical need for retinal degenerative diseases with no current treatment options. Clinical trials are ongoing in different parts of the world using stem cell-derived retinal pigment epithelium (RPE). This review focuses on scientific and regulatory considerations when developing an iPSC-derived RPE cell therapy from the development of a robust and efficient differentiation protocol to critical quality control assays for cell validation, the choice of an appropriate animal model for preclinical testing, and the regulatory aspects that dictate the final approval for proceeding to a first-in-human clinical trial.

Indexed as

Induced Pluripotent Stem CellsAnimalsCell DifferentiationHumansModels, AnimalRetinal Pigment Epithelium

Identifiers

PMID37487631
PMCPMC10910357
OpenAlexW4385197805

What OpenQuestion holds

Textmetadata
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.