Evidence map›Paper›PMID 36058548›Full record

GuidelineTransplantation and cellular therapy2022

Nomenclature for Cellular and Genetic Therapies: A Need for Standardization.

Akshay Sharma, Stephanie Farnia, Folashade Otegbeye, Amy Rinkle, Jugna Shah, Nirali N Shah, Saar Gill, Marcela V Maus

Abstract readPractice Guideline
In one paragraph

Guideline in Transplantation and cellular therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

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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.

Akshay SharmaDepartment of Bone Marrow Transplantation and Cellular Therapy, St. Jude Children's Research Hospital, Memphis, Tennessee. Electronic address: akshay.sharma@stjude.org.
Stephanie FarniaNimitt Consulting, Spicer, Minnesota.
Folashade OtegbeyeBone Marrow Transplantation and Immunotherapy Program, Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, Washington.
Amy RinkleNimitt Consulting, Spicer, Minnesota.
Jugna ShahNimitt Consulting, Spicer, Minnesota.
Nirali N ShahPediatric Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
Saar GillCell Therapy and Transplantation program, Division of Hematology-Oncology, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.
Marcela V MausCellular Immunotherapy Program and Cancer Center, Massachusetts General Hospital, Charlestown, Massachusetts; Harvard Medical School, Boston, Massachusetts.

Funding

Immunotherapeutic approaches to treat pediatric hematologic malignanciesZIABC011823 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SHAH, NIRALI · 2019 to 2025
$6.1M
Intramural NIH HHS ZIA BC011823
6 · The paper itself

Abstract

As the field of cellular and genetic therapies transitions from a scientific concept to a clinical reality, it has become evident that there are several conflicting or imprecise nomenclatures to describe these novel therapeutic products. The lack of uniformity and accuracy in the terminology often creates regulatory, educational, administrative, and billing quagmires. Standardization of the nomenclature for these therapeutic products is essential for creation of a harmonized regulatory and developmental framework, development of training paradigms and educational programs, equitable and rational decisions about accessibility, and consistency in the billing and coding structures used for reimbursement. Here we propose an updated framework as a foundation for categorizing these cell-based and genetically modified therapies.

Indexed as

Genetic TherapyReference StandardsCellular therapyGene therapyImmune effector cell therapy

Identifiers

PMID36058548
PMCPMC9729423

What OpenQuestion holds

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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.