Evidence map›Paper›PMID 34613357›Full record

Trial reportTranslational vision science & technology2021

One-Year Follow-Up in a Phase 1/2a Clinical Trial of an Allogeneic RPE Cell Bioengineered Implant for Advanced Dry Age-Related Macular Degeneration.

Amir H Kashani, Jane S Lebkowski, Firas M Rahhal, Robert L Avery, Hani Salehi-Had, Sanford Chen, Clement Chan, Neal Palejwala, April Ingram, Wei Dang and 12 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Translational vision science & technology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 2 pooled it
4.9field-weighted citation impact, top 3% 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

46 citing papers in PubMed, 2 syntheses or guidelines pooled it, 83 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Cell therapy for age-related macular degeneration.Mammalian genome : official journal of the International Mammalian Genome Society · 2026
    Review
  5. Review
  6. Review
  7. Review
  8. Utilization of Stem Cells in Medicine: A Narrative Review.International journal of molecular sciences · 2025
    Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Atrophic Macular Degeneration and Stem Cell Therapy: A Clinical Review.Advances in experimental medicine and biology · 2025
    Review
  17. Article
  18. Article
  19. Review
  20. 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

22 authors at 11 institutions in 1 country.

Amir H KashaniWilmer Eye Institute, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
Jane S LebkowskiRegenerative Patch Technologies, Menlo Park, CA, USA.
Firas M RahhalRetina-Vitreous Associates Medical Group, Beverly Hills, CA, USA.
Robert L AveryCalifornia Retina Consultants, Santa Barbara, CA, USA.
Hani Salehi-HadAtlantis Eye Care, Huntington Beach, CA, USA.
Sanford ChenOrange County Retina Medical Group, Santa Ana, CA, USA.
Clement ChanSouthern California Desert Retina Consultants, Palm Desert, CA, USA.
Neal PalejwalaRetinal Consultants of Arizona, Retinal Research Institute LLC, Phoenix, AZ, USA.
April IngramRegenerative Patch Technologies, Menlo Park, CA, USA.
Wei DangCenter for Biomedicine and Genetics, Beckman Research Institute of City of Hope, Duarte, CA, USA.
Chih-Min LinCenter for Biomedicine and Genetics, Beckman Research Institute of City of Hope, Duarte, CA, USA.
Debbie MitraUSC Roski Eye Institute, USC Ginsburg Institute for Biomedical Therapeutics and Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Britney O PenningtonRegenerative Patch Technologies, Menlo Park, CA, USA.
Cassidy HinmanRegenerative Patch Technologies, Menlo Park, CA, USA.
Mohamed A FaynusRegenerative Patch Technologies, Menlo Park, CA, USA.
Jeffrey K BaileyRegenerative Patch Technologies, Menlo Park, CA, USA.
Sukriti MohanUSC Roski Eye Institute, USC Ginsburg Institute for Biomedical Therapeutics and Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Narsing RaoDepartment of Pathology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Lincoln V JohnsonRegenerative Patch Technologies, Menlo Park, CA, USA.
Dennis O CleggCenter for Stem Cell Biology and Engineering, Neuroscience Research Institute, University of California, Santa Barbara, CA, USA.
David R HintonUSC Roski Eye Institute, USC Ginsburg Institute for Biomedical Therapeutics and Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Mark S HumayunUSC Roski Eye Institute, USC Ginsburg Institute for Biomedical Therapeutics and Department of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
Menlo School · USUniversity of California, Santa Barbara · USUniversity of Southern California · USCity of Hope · USSouthern California Eye Institute · USCalifornia Retina Consultants · USEye Care Associates · USJohns Hopkins Medicine · USRetinal Consultants of Arizona · USRetina Vitreous Associates Medical Group · USSouthern California Desert Retina Consultants · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: To report 1-year follow-up of a phase 1/2a clinical trial testing a composite subretinal implant having polarized human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells on an ultrathin parylene substrate in subjects with advanced non-neovascular age-related macular degeneration (NNAMD). Methods: The phase 1/2a clinical trial included 16 subjects in two cohorts. The main endpoint was safety assessed at 365 days using ophthalmic and systemic exams. Pseudophakic subjects with geographic atrophy (GA) and severe vision loss were eligible. Low-dose tacrolimus immunosuppression was utilized for 68 days in the peri-implantation period. The implant was delivered to the worst seeing eye with a custom subretinal insertion device in an outpatient setting. A data safety monitoring committee reviewed all results. Results: The treated eyes of all subjects were legally blind with a baseline best-corrected visual acuity (BCVA) of ≤ 20/200. There were no unexpected serious adverse events. Four subjects in cohort 1 had serious ocular adverse events, including retinal hemorrhage, edema, focal retinal detachment, or RPE detachment, which was mitigated in cohort 2 using improved hemostasis during surgery. Although this study was not powered to assess efficacy, treated eyes from four subjects showed an increased BCVA of >5 letters (6-13 letters). A larger proportion of treated eyes experienced a >5-letter gain when compared with the untreated eye (27% vs. 7%; P = not significant) and a larger proportion of nonimplanted eyes demonstrated a >5-letter loss (47% vs. 33%; P = not significant). Conclusions: Outpatient delivery of the implant can be performed routinely. At 1 year, the implant is safe and well tolerated in subjects with advanced dry AMD. Translational Relevance: This work describes the first clinical trial, to our knowledge, of a novel implant for advanced dry AMD.

Indexed as

Geographic AtrophyHematopoietic Stem Cell TransplantationMacular DegenerationFollow-Up StudiesHumansVisual Acuity

Identifiers

PMID34613357
PMCPMC8496407
OpenAlexW3202005642

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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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.