Evidence map›Paper›PMID 34209541›Full record

ArticleJournal of clinical medicine2021

Arguments against the Requirement of a Biological License Application for Human Pancreatic Islets: The Position Statement of the Islets for US Collaborative Presented during the FDA Advisory Committee Meeting.

Piotr Witkowski, Jon Odorico, Jordan Pyda, Roi Anteby, Robert J Stratta, Beth A Schrope, Mark A Hardy, John Buse, Joseph R Leventhal, Wanxing Cui and 21 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

31 authors.

Piotr WitkowskiTransplantation Institute, Department of Surgery, University of Chicago, Chicago, IL 60637, USA.
Jon OdoricoDivision of Transplantation, Department of Surgery, University of Wisconsin, School of Medicine and Public Health, Madison, WI 53792, USA.
Jordan PydaBeth Israel Deaconess Medical Center, Department of Surgery, Harvard Medical School, Boston, MA 02115, USA.ORCID 0000-0002-2833-3953
Roi AntebyHarvard T.H. Chan School of Public Health, Boston, MA 02115, USA.
Robert J StrattaSection of Transplantation, Department of Surgery, Wake Forest School of Medicine, Winston-Salem, NC 27101, USA.
Beth A SchropeDepartment of Surgery, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA.
Mark A HardyDepartment of Surgery, Columbia University College of Physicians and Surgeons, New York, NY 10032, USA.
John BuseDivision of Endocrinology, Department of Medicine, University of NC, Chapel Hill, NC 27516, USA.
Joseph R LeventhalDepartment of Surgery, Northwestern University School of Medicine, Chicago, IL 60611, USA.
Wanxing CuiCell Therapy Manufacturing Facility, Georgetown University Hospital, Washington, DC 20007, USA.
Shakir HusseinDetroit Medical Center, Department of Surgery, Wayne State School of Medicine, Detroit, MI 48201, USA.
Silke NiederhausDepartment of Surgery, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
Jason GagliaJoslin Diabetes Center, Harvard Medical School, Boston, MA 02215, USA.
Chirag S DesaiDepartment of Surgery, Section of Transplantation, University of NC, Chapel Hill, NC 27516, USA.ORCID 0000-0002-3784-0973
Martin WijkstromDepartment of Surgery, University of Pittsburgh, Pittsburgh, PA 15260, USA.
Fouad KandeelDepartment of Translational Research and Cellular Therapeutics, Diabetes and Metabolism Research Institute, Beckman Research Institute of City of Hope, Duarte, CA 91010, USA.
Piotr J BachulTransplantation Institute, Department of Surgery, University of Chicago, Chicago, IL 60637, USA.ORCID 0000-0002-7694-1793
Yolanda Tai BeckerTransplantation Institute, Department of Surgery, University of Chicago, Chicago, IL 60637, USA.
Ling-Jia WangTransplantation Institute, Department of Surgery, University of Chicago, Chicago, IL 60637, USA.
R Paul RobertsonDivision of Endocrinology and Metabolism, Department of Internal Medicine, University of Washington, Seattle, WA 98133, USA.
Oyedolamu K OlaitanDepartment of Surgery, Rush University Medical Center, Chicago, IL 60612, USA.
Tomasz KozlowskiDivision of Transplantation, Department of Surgery, The University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.
Peter L AbramsMedStar Georgetown Transplant Institute, Washington, DC 20007, USA.
Michelle A JosephsonDepartment of Medicine, University of Chicago, Chicago, IL 60637, USA.
Kenneth A AndreoniDepartment of Surgery, University of Florida, College of Medicine, Gainesville, FL 32610-0118, USA.ORCID 0000-0002-3143-5010
Robert C HarlandDepartment of Surgery, University of Arizona, Tucson, AZ 85711, USA.
Raja KandaswamyDepartment of Surgery, University of Minnesota, Minneapolis, MN 55455, USA.
Andrew M PosseltDivision of Transplantation, Department of Surgery, University of California San Francisco, San Francisco, CA 94143, USA.
Gregory L SzotDivision of Transplantation, Department of Surgery, University of California San Francisco, San Francisco, CA 94143, USA.
Camillo RicordiDiabetes Research Institute and Cell Transplant Center, University of Miami, Miami, FL 33136, USA.
On Behalf Of The Islets For Us Collaborative

Funding

Pilot & Feasibility ProgramP30DK124723 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI P Darrell Neufer · 2020 to 2026
$11.0M
NIDDK NIH HHS P30 DK124723
6 · The paper itself

Abstract

The Food and Drug Administration (FDA) has been regulating human islets for allotransplantation as a biologic drug in the US. Consequently, the requirement of a biological license application (BLA) approval before clinical use of islet transplantation as a standard of care procedure has stalled the development of the field for the last 20 years. Herein, we provide our commentary to the multiple FDA's position papers and guidance for industry arguing that BLA requirement has been inappropriately applied to allogeneic islets, which was delivered to the FDA Cellular, Tissue and Gene Therapies Advisory Committee on 15 April 2021. We provided evidence that BLA requirement and drug related regulations are inadequate in reassuring islet product quality and potency as well as patient safety and clinical outcomes. As leaders in the field of transplantation and endocrinology under the "Islets for US Collaborative" designation, we examined the current regulatory status of islet transplantation in the US and identified several anticipated negative consequences of the BLA approval. In our commentary we also offer an alternative pathway for islet transplantation under the regulatory framework for organ transplantation, which would address deficiencies of in current system.

Indexed as

allogenic islet cell transplantationFood and Drug Administrationpancreas

Identifiers

PMID34209541
PMCPMC8269003

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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.