Evidence map›Paper›PMID 39469665›Full record

ReviewTransplant international : official journal of the European Society for Organ Transplantation2024

ESOT Roadmap for Advanced Therapy Medicinal Products in Transplantation: Navigating Regulatory Challenges to Enhance Access and Care.

Ekaterine Berishvili, Lorenzo Piemonti, Eelco J P de Koning, Sandra Lindstedt, Hanne Scholz, William E Scott, Celine Auxenfans, Paul Johnson, Dominique E Martin, Penilla Gunther and 3 more

Abstract readReview
In one paragraph

Review in Transplant international : official journal of the European Society for Organ Transplantation, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–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

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Organoids for transplant research.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Article
  6. Can european law keep pace with biomedical innovation? The reinvention of transplantation regulation.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Article
  7. Regulatory approach to manipulated organs in Europe: preserving human organs as non-commercial goods.Transplant international : official journal of the European Society for Organ Transplantation · 2026
    Review
  8. Article
  9. Advances in Cell and Gene Therapy for Rare Disease Treatment.International journal of stem cells · 2025
    Review
  10. Allogeneic Islet Transplantation: Chronicle of a Death Foretold?Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Article
  11. The Last Mile in Beta-Cell Replacement Therapy for Type 1 Diabetes: Time to Grow Up.Transplant international : official journal of the European Society for Organ Transplantation · 2025
    Review
  12. Article
  13. 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

13 authors.

Ekaterine BerishviliCell Isolation and Transplantation Centre, Department of Surgery, Geneva University Hospitals, Laboratory of Tissue Engineering and Organ Regeneration, Department of Surgery, University of Geneva, Geneva, Switzerland.
Lorenzo PiemontiDiabetes Research Institute, IVita-Salute San Raffaele University, Milan, Italy.
Eelco J P de KoningDepartment of Internal Medicine, Leiden University Medical Center, Leiden, Netherlands.
Sandra LindstedtDepartment of Clinical Sciences, Lund University, Lund, Sweden.
Hanne ScholzHybrid Technology Hub Centre of Excellence, Institute of Basic Medical Science, University of Oslo, Oslo, Norway.
William E ScottRegenerative Medicine, Stem Cells, and Transplantation Theme, Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom.
Celine AuxenfansBanque de Tissus et de Cellules des Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon, France.
Paul JohnsonOxford Consortium for Islet Transplantation, Oxford Centre for Diabetes, Endocrinology, and Metabolism (OCDEM), Churchill Hospital, University of Oxford, Oxford, United Kingdom.
Dominique E MartinSchool of Medicine, Faculty of Health, Deakin University, Waurn Ponds, VIC, Australia.
Penilla GuntherThe Swedish Parliament, Stockholm, Sweden.
Devi MeyThe European Society for Organ Transplantation, Amsterdam, Netherlands.
Luciano PotenaIstituto di Ricovero e Cura a Carattere Scientifico (Scientific Institute for Research, Hospitalization, and Healthcare) (IRCCS) University Hospital of Bologna Sant Orsola Polyclinic, Bologna, Italy.
Olivier ThaunatCentre International de Recherche en Infectiologie (CIRI), Université de Lyon, Inserm, U1111, Université Claude Bernard Lyon 1, CNRS, UMR5308, ENS de Lyon, Lyon, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The field of organ transplantation is experiencing a transformative shift with the rise of Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic cell therapies, and tissue-engineered products. These therapies offer new, potentially curative treatments for longstanding medical challenges, impacting numerous patients. However, their adoption is hindered by complex regulatory frameworks, high production costs, and inconsistent access across Europe. The ESOT ATMP Task Force's position paper analyzes these challenges from research to clinical application, advocating for a coordinated strategy to position Europe as a leader in ATMP development. It proposes specific actions such as streamlining regulatory pathways to accelerate approvals, boosting funding for ATMP research, and creating specialized facilities for development and implementation. The paper also highlights the critical roles of patient engagement and real-world evidence in optimizing clinical and regulatory practices.

Indexed as

Cell- and Tissue-Based TherapyGenetic TherapyHealth Services AccessibilityOrgan TransplantationTissue EngineeringEuropeHumansadvanced therapy medicinal products (ATMPs)cell transplantationorgan transplantationpatient accessregulatory challenges

Identifiers

PMID39469665
PMCPMC11513584

What OpenQuestion holds

Textmetadata
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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.