Evidence map›Paper›PMID 35769340›Full record

ArticleStem cells international2022

GMP Compliant Production of a Cryopreserved Adipose-Derived Stromal Cell Product for Feasible and Allogeneic Clinical Use.

Mandana Haack-Sørensen, Ellen Mønsted Johansen, Lisbeth Drozd Højgaard, Jens Kastrup, Annette Ekblond

Abstract read
In one paragraph

Article in Stem cells international, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 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

5 authors.

Mandana Haack-SørensenCardiology Stem Cell Centre, The Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Rigshospitalet Copenhagen University Hospital, 2100 Copenhagen, Denmark.ORCID https://orcid.org/0000-0001-9037-8012
Ellen Mønsted JohansenCardiology Stem Cell Centre, The Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Rigshospitalet Copenhagen University Hospital, 2100 Copenhagen, Denmark.
Lisbeth Drozd HøjgaardCardiology Stem Cell Centre, The Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Rigshospitalet Copenhagen University Hospital, 2100 Copenhagen, Denmark.
Jens KastrupCardiology Stem Cell Centre, The Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Rigshospitalet Copenhagen University Hospital, 2100 Copenhagen, Denmark.
Annette EkblondCardiology Stem Cell Centre, The Centre for Cardiac, Vascular, Pulmonary and Infectious Diseases, Rigshospitalet Copenhagen University Hospital, 2100 Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The emerging field of advanced therapy medicinal products (ATMP) holds promise of treating a variety of diseases. Adipose-derived stromal cells (ASCs) are currently being marketed or tested as cell-based therapies in numerous clinical trials. To ensure safety and efficacy of treatments, high-quality products must be manufactured. A good manufacturing practice (GMP) compliant and consistent manufacturing process including validated quality control methods is critical. Product design and formulation are equally important to ensure clinical feasibility. Here, we present a GMP-compliant, xeno-free, and semiautomated manufacturing process and quality controls, used for large-scale production of a cryopreserved off-the-shelf ASC product and tested in several phase I and II allogeneic clinical applications.

Identifiers

PMID35769340
PMCPMC9236818

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.