Evidence map›Paper›PMID 20795760›Full record

ArticleCytotherapy2011

Shipping of therapeutic somatic cell products.

Theresa L Whiteside, Deborah L Griffin, Joanna Stanson, William Gooding, David McKenna, Darin Sumstad, Diane Kadidlo, Adrian Gee, April Durett, Robert Lindblad and 2 more

Open access · greenAbstract readValidation Study
In one paragraph

Article in Cytotherapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  9. Article
  10. Establishing a stem cell culture laboratory for clinical trials.Revista brasileira de hematologia e hemoterapia · 2012
    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

12 authors at 5 institutions in 1 country.

Theresa L WhitesideUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USA. whitesidetl@upmc.edu
Deborah L Griffin
Joanna Stanson
William Gooding
David McKenna
Darin Sumstad
Diane Kadidlo
Adrian Gee
April Durett
Robert Lindblad
Deborah Wood
David Styers
Emmes (United States) · USUniversity of Minnesota · USUniversity of Pittsburgh · USBaylor College of Medicine · USUPMC Health System · US

Funding

NHLBI NIH HHS N01 HB037163NHLBI NIH HHS N01 HB037164NHLBI NIH HHS N01 HB037165NHLBI NIH HHS N01 HB037166NHLBI NIH HHS N01-HB-37163NHLBI NIH HHS N01-HB-37164NHLBI NIH HHS N01-HB-37165NHLBI NIH HHS N01-HB-37166
6 · The paper itself

Abstract

BACKGROUND

aimsShipment of therapeutic somatic cells between a current good manufacturing practice (cGMP) facility and a clinic or between different cGMP facilities requires validated standard operating procedures (SOP). Under National Heart Lung & Blood Institute (NHLBI) sponsorship, the Production Assistance for Cellular Therapies (PACT) group conducted a validation study for the shipping SOP it has created, including shipments of cryopreserved somatic cells, fresh peripheral blood specimens and apheresis products.

methodsComparisons of pre- and post-shipped cells and cell products at the three participating facilities included measurements of viability, phenotypic profiles and cellular functions. The data were analyzed at the University of Pittsburgh Biostatistics Facility.

resultsNo consistent shipping effects on cell viability, phenotype or functions were detected for cryopreserved and shipped peripheral blood mononuclear cells (PBMC), monocytes, immature dendritic cells (iDC), NK-92 or cytotoxic T cells (CTL). Cryopreserved mesenchymal stromal cells (MSC) had a significantly decreased viability after shipment, but this effect was in part because of inter-laboratory variability in the viable cell counts. Shipments of fresh peripheral blood and apheresis products for the generation of CTL and dendritic cells (DC), respectively, had no significant effects on cell product quality. MSC were successfully generated from fresh bone marrow samples shipped overnight.

conclusionsThis validation study provides a useful set of data for guiding shipments of therapeutic somatic cells in multi-institutional clinical trials.

Indexed as

Biological ProductsCell SurvivalCryopreservationBlood Specimen CollectionCommerceHealth FacilitiesHumansQuality ControlBiological Products

Identifiers

PMID20795760
PMCPMC7982143
OpenAlexW2149710269

What OpenQuestion holds

Textmetadata
LicenceTDM
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.