Evidence map›Paper›PMID 34210363›Full record

ReviewStem cell research & therapy2021

Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions.

Pauline François, Giulio Rusconi, Laurent Arnaud, Luca Mariotta, Laurent Giraudo, Greta Minonzio, Julie Veran, Baptiste Bertrand, Chloé Dumoulin, Fanny Grimaud and 9 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Stem cell research & therapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing 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

13 citing papers in PubMed.

  1. Article
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  5. Ultrasound-Guided PRP and SVF Therapy Shows Sustained Improvement in Severe Knee Osteoarthritis: A 12-Month Retrospective Study.Medical science monitor : international medical journal of experimental and clinical research · 2024
    Article
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  7. Review
  8. Article
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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

19 authors.

Pauline FrançoisCell Therapy Department, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, 147 Bd Baille, 13005, Marseille, France.
Giulio RusconiSwiss Stem Cell Foundation, Gentilino, Lugano, Switzerland.
Laurent ArnaudVascular Biology Department, Hôpital de la Conception, AP-HM, Marseille, France.
Luca MariottaSwiss Stem Cell Foundation, Gentilino, Lugano, Switzerland.
Laurent GiraudoCell Therapy Department, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, 147 Bd Baille, 13005, Marseille, France.
Greta MinonzioSwiss Stem Cell Foundation, Gentilino, Lugano, Switzerland.
Julie VeranCell Therapy Department, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, 147 Bd Baille, 13005, Marseille, France.
Baptiste BertrandPlastic Surgery Department, Hôpital de la Conception, AP-HM, Marseille, France.
Chloé DumoulinCell Therapy Department, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, 147 Bd Baille, 13005, Marseille, France.
Fanny GrimaudCell Therapy Department, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, 147 Bd Baille, 13005, Marseille, France.
Luc LyonnetVascular Biology Department, Hôpital de la Conception, AP-HM, Marseille, France.
Dominique CasanovaPlastic Surgery Department, Hôpital de la Conception, AP-HM, Marseille, France.
Camille GiverneNormandie Univ, UNIROUEN, INSERM, U1234, Rouen University Hospital, Department of Immunology and Biotherapy, Rouen, France.
Audrey CrasAssistance Publique-Hôpitaux de Paris, Saint-Louis Hospital, Cell Therapy Unit, Cord blood Bank and CIC-BT501, Paris, France.
Guy MagalonRemedex, Marseille, France.
Françoise Dignat-GeorgeAix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.
Florence SabatierCell Therapy Department, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, 147 Bd Baille, 13005, Marseille, France.
Jeremy Magalon *Cell Therapy Department, Hôpital de la Conception, AP-HM, INSERM CIC BT 1409, 147 Bd Baille, 13005, Marseille, France. Jeremy.magalon@ap-hm.fr.
Gianni Soldati *Swiss Stem Cell Foundation, Gentilino, Lugano, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEven though the manufacturing processes of the stromal vascular fraction for clinical use are performed in compliance with the good manufacturing practices applying to advanced therapy medicinal products, specifications related to stromal vascular fraction quality remain poorly defined. We analyzed stromal vascular fraction clinical batches from two independent good manufacturing practices-compliant manufacturing facilities, the Swiss Stem Cell Foundation (SSCF) and Marseille University Hospitals (AP-HM), with the goal of defining appropriate and harmonized release acceptance criteria.

methodsThis retrospective analysis reviewed the biological characteristics of 364 batches of clinical-grade stromal vascular fraction. Collected data included cell viability, recovery yield, cell subset distribution of stromal vascular fraction, and microbiological quality.

resultsStromal vascular fraction from SSCF cohort demonstrated a higher viability (89.33% ± 4.30%) and recovery yield (2.54 × 10

conclusionsBoth centers agreed that a good manufacturing practices-compliant stromal vascular fraction batch should exert a viability equal or superior to 80%, a minimum recovery yield of 1.50 × 10

Indexed as

Adipose TissueEndothelial CellsCell SurvivalRetrospective StudiesStromal CellsAdipose tissueAdvanced therapy medicinal productCell subset distributionFlow cytometryGMP productionStromal vascular fraction

Identifiers

PMID34210363
PMCPMC8252207

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Registered trials

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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.