Evidence map›Paper›PMID 39346761›Full record

ArticleBio-protocol2024

A Full Good Manufacturing Practice-Compliant Protocol for Corneal Stromal Stem Cell Cultivation.

Mithun Santra, Yen-Michael S Hsu, Shaheen Khadem, Sydney Radencic, Martha L Funderburgh, Onkar B Sawant, Deepinder K Dhaliwal, Vishal Jhanji, Gary H F Yam

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Bio-protocol, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Mithun SantraCorneal Regeneration Laboratory, Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.
Yen-Michael S HsuImmunologic Monitoring and Cellular Products Laboratory, Hillman Cancer Centre, University of Pittsburgh, Pittsburgh, PA, USA.
Shaheen KhademImmunologic Monitoring and Cellular Products Laboratory, Hillman Cancer Centre, University of Pittsburgh, Pittsburgh, PA, USA.
Sydney RadencicImmunologic Monitoring and Cellular Products Laboratory, Hillman Cancer Centre, University of Pittsburgh, Pittsburgh, PA, USA.
Martha L FunderburghCorneal Regeneration Laboratory, Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.
Onkar B SawantCenter for Vision and Eye Banking Research, Eversight, Cleveland, OH, USA.
Deepinder K DhaliwalCorneal Regeneration Laboratory, Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.
Vishal JhanjiCorneal Regeneration Laboratory, Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.
Gary H F YamCorneal Regeneration Laboratory, Department of Ophthalmology, University of Pittsburgh, Pittsburgh, PA, USA.

Funding

Virus Production and Manipulation of Protein/Gene Expression ModuleP30EY008098 · NEI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Yuanyuan Chen · 1989 to 2026
$17.8M
Stem Cells for Corneal EngineeringR01EY016415 · NEI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI DU, YIQIN · 2006 to 2018
$4.5M
Cell Therapy Program with Scale-up cGMP Manufacturing of Human Corneal Stromal Stem CellsU01EY035252 · NEI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI SIKDER, DEVANJAN, YAM, HIN FAI · 2023 to 2024
$1.0M
NEI NIH HHS P30 EY008098NEI NIH HHS R01 EY016415NEI NIH HHS U01 EY035252
6 · The paper itself

Abstract

Corneal scarring, a significant cause of global blindness, results from various insults, including trauma, infections, and genetic disorders. The conventional treatment to replace scarred corneal tissues includes partial or full-thickness corneal transplantation using healthy donor corneas. However, only 1 in 70 individuals with treatable corneal scarring can undergo surgery, due to the limited supply of transplantable donor tissue. Our research focuses on cell-based strategies, specifically ex vivo-expanded corneal stromal stem cells (CSSCs), to address corneal scarring. Preclinical studies have demonstrated the efficacy of CSSC treatment in reducing corneal inflammation and fibrosis, inhibiting scar formation, and regenerating native stromal tissue. Mechanisms include CSSC differentiation into stromal keratocytes and the expression of regenerative cytokines. Here, we present a good manufacturing practice (GMP)-compliant protocol to isolate and expand human CSSCs. This method paves the way to produce clinical-grade CSSCs for transplantation and clinical trials. Key features • This protocol utilizes surgical skills to dissect human corneal tissues for CSSC isolation. • The yield and features of CSSCs rely on donor tissue quality (freshness) and have donor-to-donor variability. • Up to 0.5 billion CSSCs can be generated from a single cornea specimen, and cells at passage 3 are suitable for treatment uses.

Indexed as

Anterior limbal stromaCorneal opacitiesCorneal stromal stem cellsGood manufacturing practicesStandard operating protocol

Identifiers

PMID39346761
PMCPMC11427334

What OpenQuestion holds

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LicenceCC BY
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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.