Evidence map›Paper›PMID 37443822›Full record

ArticleCells2023

Drug Regulatory-Compliant Validation of a qPCR Assay for Bioanalysis Studies of a Cell Therapy Product with a Special Focus on Matrix Interferences in a Wide Range of Organ Tissues.

Hannes M Schröder, Elke Niebergall-Roth, Alexandra Norrick, Jasmina Esterlechner, Christoph Ganss, Markus H Frank, Mark A Kluth

Open access · goldAbstract readValidation Study
In one paragraph

Article in Cells, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 37% 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

4 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
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

7 authors at 2 institutions in 3 countries.

Hannes M SchröderRHEACELL GmbH & Co. KG, 69120 Heidelberg, Germany.
Elke Niebergall-RothRHEACELL GmbH & Co. KG, 69120 Heidelberg, Germany.ORCID 0000-0001-7846-3388
Alexandra NorrickRHEACELL GmbH & Co. KG, 69120 Heidelberg, Germany.
Jasmina EsterlechnerRHEACELL GmbH & Co. KG, 69120 Heidelberg, Germany.
Christoph GanssRHEACELL GmbH & Co. KG, 69120 Heidelberg, Germany.
Markus H FrankDepartment of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.ORCID 0000-0002-1312-0488
Mark A KluthRHEACELL GmbH & Co. KG, 69120 Heidelberg, Germany.
Rheacell (Germany) · DEEdith Cowan University · AU

Funding

Stem Cell Integral Membrane Transporter ABCB5 and Dermal RegenerationP01AG071463 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI Markus H. Frank · 2022 to 2026
$13.6M
ABCB5-positive stem cells for LSCD therapyR01EY025794 · NEI · BOSTON CHILDREN'S HOSPITAL · PI NATASHA Y FRANK, Markus H. Frank · 2016 to 2026
$6.1M
Multipotent ABCB5-positive cell therapeutics for corneal diseaseR24EY028767 · NEI · BRIGHAM AND WOMEN'S HOSPITAL · PI FRANK, MARKUS H., FRANK, NATASHA Y · 2018 to 2022
$5.9M
Skin-Intrinsic Immunosuppressive Mesenchymal Stem Cells and aGVHDR01HL161087 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI FRANK, MARKUS H., FRANK, NATASHA Y · 2022 to 2025
$1.7M
NEI NIH HHS R01 EY025794NEI NIH HHS R01EY025794NEI NIH HHS R24 EY028767NEI NIH HHS R24EY028767NHLBI NIH HHS R01 HL161087NIA NIH HHS 1P01AG071463NIA NIH HHS P01 AG071463
6 · The paper itself

Abstract

Quantitative polymerase chain reaction (qPCR) has emerged as an important bioanalytical method for assessing the pharmacokinetics of human-cell-based medicinal products after xenotransplantation into immunodeficient mice. A particular challenge in bioanalytical qPCR studies is that the different tissues of the host organism can affect amplification efficiency and amplicon detection to varying degrees, and ignoring these matrix effects can easily cause a significant underestimation of the true number of target cells in a sample. Here, we describe the development and drug regulatory-compliant validation of a TaqMan

Indexed as

Mesenchymal Stem CellsPolymerase Chain ReactionAnimalsHumansMiceTransplantation, HeterologousABCB5biodistributioncell therapyHSSATA17 sequencemesenchymal stromal cellsquantitative polymerase chain reactionspike recoverytissue matrix effects

Identifiers

PMID37443822
PMCPMC10340683
OpenAlexW4383368660

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.