Evidence map›Paper›PMID 27091398›Full record

ReviewRegenerative medicine2016

From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU.

Graziella Pellegrini, Alessandro Lambiase, Claudio Macaluso, Augusto Pocobelli, Sophie Deng, Gian Maria Cavallini, Roza Esteki, Paolo Rama

Open access · hybridAbstract readReview
In one paragraph

Review in Regenerative medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
6.8field-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

26 citing papers in PubMed, 67 citations in OpenAlex.

  1. Review
  2. [Limbal diseases].Die Ophthalmologie · 2026
    Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Stairways to Advanced Therapies for Epidermolysis Bullosa.Cold Spring Harbor perspectives in biology · 2023
    Review
  9. The Evolving Landscape of Potency Assays.Advances in experimental medicine and biology · 2023
    Article
  10. Article
  11. The Art of Stem Cell-Based Therapy.Advances in experimental medicine and biology · 2023
    Article
  12. Regenerative therapy for the Cornea.Progress in retinal and eye research · 2022
    Review
  13. Review
  14. Review
  15. The Limbal Niche and Regenerative Strategies.Vision (Basel, Switzerland) · 2021
    Review
  16. Review
  17. [Wound healing following amniotic membrane, limbal stem cell and corneal transplantation].Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft · 2020
    Review
  18. Review
  19. Article
  20. 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

8 authors at 7 institutions in 2 countries.

Graziella PellegriniCentre for Regenerative Medicine "Stefano Ferrari", University of Modena and Reggio Emilia, via G.Gottardi 100, Modena, 41125, Italy; Holostem Terapie Avanzate, Modena, Italy.
Alessandro LambiaseDepartment of Sense Organs, University of Rome "Sapienza", viale Regina Elena, Rome, Italy.
Claudio MacalusoUnit of Ophthalmology, University of Parma, Via Gramsci 14, 43126 Parma, Italy; IMEM - CNR (Italian National Reserach Council), Parco Area delle Scienze 37/A - 43124 Parma, Italy.
Augusto PocobelliOphthalmology Unit-Eye Bank, S. Giovanni Addolorata Hospital, via S. Stefano Rotondo 9, Rome, Italy.
Sophie DengCornea Division Stein Eye Institute, UCLA 100 Stein Plaza Los Angeles, CA 90095, USA.
Gian Maria CavalliniOphthalmology Unit, Policlinico University Hospital, University of Modena & Reggio Emilia, via Del Pozzo 71, Modena, 41125, Italy.
Roza EstekiCentre for Regenerative Medicine "Stefano Ferrari", University of Modena and Reggio Emilia, via G.Gottardi 100, Modena, 41125, Italy; Holostem Terapie Avanzate, Modena, Italy.
Paolo RamaCornea & Ocular Surface Unit San Raffaele Scientific Institute Via Olgettina, 60-20132 Milano, Italy.
Azienda Ospedaliera San Giovanni Addolorata · ITSan Raffaele University of Rome · ITSapienza University of Rome · ITSteinhauser (Czechia) · CZTecnologie Avanzate (Italy) · ITUniversity of Modena and Reggio Emilia · ITUniversity of Parma · IT

Funding

Ex Vivo Expansion of Human Limbal Stem Cells for TransplantationR01EY021797 · NEI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Sophie Deng · 2012 to 2026
$5.1M
NEI NIH HHS R01 EY021797
6 · The paper itself

Abstract

In 1997, the human corneal epithelium was reconstructed in vitro and transplanted on patients. Later, it became a routine treatment, before regulations considered advanced therapy medicinal products and drugs on the same lines. Manufacturing, before and after good manufacturing practice setting, was established in different facilities and the clinical application in several hospitals. Advanced therapy medicinal products, including stem cells, are unique products with different challenges than other drugs: some uncertainties, in addition to benefit, cannot be avoided. This review will focus on all recent developments in the stem cell-based corneal therapy.

Indexed as

Plants, MedicinalStem Cell TransplantationTherapies, InvestigationalAnimalsCorneal DiseasesEpithelium, CornealEuropean UnionHumansTissue Engineeringadult corneal stem cellsartificial organsATMP commercializationcell therapyculture/differentiation of stem cells (niche)ophthalmologyregenerative medicinetissue engineeringtranslational studiestransplantation

Identifiers

PMID27091398
PMCPMC5561870
OpenAlexW2341074650

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.