Evidence map›Paper›PMID 40253438›Full record

ArticleNPJ Regenerative medicine2025

Allogeneic RPE cell suspension manufactured at scale demonstrating preclinical safety and efficacy led to IND approval.

Lalitha Soundararajan, Harshini Surendran, Niharika Patlolla, Rajani Battu, Jonathan Stoddard, Sebastian Arrizabalaga, Zengping Liu, Gopal Lingam, Xinyi Su, Renee C Ryals and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ Regenerative medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06394232 (A Phase 1/2a Multi-Center, Dose-Escalation Study to Evaluate the Safety & Efficacy of Eyecyte-RPE™ When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT06394232 phase1 / phase2recruitingnot on this map

A Phase 1/2a Multi-Center, Dose-Escalation Study to Evaluate the Safety & Efficacy of Eyecyte-RPE™ When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration

TypeinterventionalSponsorEyestem Research Pvt. Ltd.Ran2024 to 2030Enrolled54ConditionsRetinal Disease, Macular Degeneration, Age-Related Macular Degeneration, Geographic AtrophyArmsEyecyte-RPE™
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
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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

11 authors.

Lalitha Soundararajan *Eyestem Research, Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru, India.
Harshini Surendran *Eyestem Research, Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru, India.ORCID http://orcid.org/0009-0007-8114-4987
Niharika PatlollaEyestem Research, Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru, India.
Rajani BattuEyestem Research, Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru, India.
Jonathan StoddardCasey Eye Institute, Oregon Health and Science University (OHSU), Portland, Oregon, USA.
Sebastian ArrizabalagaCasey Eye Institute, Oregon Health and Science University (OHSU), Portland, Oregon, USA.
Zengping LiuDepartment of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Gopal LingamDepartment of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
Xinyi SuDepartment of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.ORCID http://orcid.org/0000-0002-1480-6713
Renee C RyalsCasey Eye Institute, Oregon Health and Science University (OHSU), Portland, Oregon, USA.
Rajarshi PalEyestem Research, Centre for Cellular and Molecular Platforms (C-CAMP), Bengaluru, India. rajarshi.pal@eyestem.com.ORCID http://orcid.org/0000-0001-6334-4562

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Cell replacement therapy is a promising therapeutic option for dry age-related macular degeneration (AMD). In this study, we outline our design for scalable manufacture with appropriate quality gates and present in vivo data for establishing preclinical safety and efficacy of an induced pluripotent stem cell (iPSC)-derived retinal pigment epithelium (RPE) product, thus laying the foundation for Phase 1/2a trial approval in India (ClinicalTrials.gov ID: NCT06394232; date of registration: 23

Identifiers

PMID40253438
PMCPMC12009284

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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.