Evidence map›Paper›PMID 28602891›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2017

Manufacture of Autologous CD34

Carolyn A Keever-Taylor, Shelly Heimfeld, Kaitlyn C Steinmiller, Richard A Nash, Keith M Sullivan, Christine W Czarniecki, Tomeka C Granderson, Julia S Goldstein, Linda M Griffith

2 registry-linked trialsAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this 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.

NCT00114530 phase2 / phase3completednot on this map

A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2005 to 2016Enrolled75ConditionsScleroderma, Systemic, Sclerosis, Autoimmune DiseaseArmsmHSCT, cyclophosphamide
NCT00288626 phase2completednot on this map

A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2006 to 2015Enrolled25ConditionsRelapsing-Remitting Multiple SclerosisArmsGranulocyte-colony stimulating factor (G-CSF) and prednisone, Carmustine, etoposide, cytarabine, and melphalan (BEAM), Autologous hematopoietic stem cell transplant
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Systemic Sclerosis as an Indication for Autologous Hematopoietic Cell Transplantation: Position Statement from the American Society for Blood and Marrow Transplantation.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2018
    Review
  7. 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

9 authors.

Carolyn A Keever-TaylorDepartments of Medicine, Microbiology and Molecular Genetics, Medical College of Wisconsin, Milwaukee, Wisconsin.
Shelly HeimfeldClinical Research Division, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center, Seattle, Washington; Nohla Therapeutics, Seattle, Washington.
Kaitlyn C SteinmillerRho Federal Systems, Inc., Chapel Hill, North Carolina.
Richard A NashColorado Blood Cancer Institute, Denver, Colorado.
Keith M SullivanDepartment of Medicine, Duke University, Durham, North Carolina.
Christine W CzarnieckiDivision of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Tomeka C GrandersonDivision of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Julia S GoldsteinDivision of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.
Linda M GriffithDivision of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland. Electronic address: LGriffith@niaid.nih.gov.

Funding

Immune Tolerance Network UM1 2023 SupplementUM1AI109565 · NIAID · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI Mark S Anderson, Jane Hoyt Buckner · 2014 to 2026
$451.6M
Transplantation GroupUM2AI117870 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI DAVID, GLORIA · 2015 to 2023
$208.1M
Stem Cell and Transplantation BiologyU54DK106829 · NIDDK · FRED HUTCHINSON CANCER RESEARCH CENTER · PI DEREK L STIREWALT · 2015 to 2026
$9.1M
STEM CELL TRANSPLANTATION FOR TX OF AUTOIMMUNE DISEASES-N01AI5419N01AI005419 · NIAID · DUKE UNIVERSITY · PI SULLIVAN, KEITH M · 2000 to 2006
$6.2M
Intramural NIH HHS Z99 AI999999NIAID NIH HHS HHSN272200900057CNIAID NIH HHS HHSN272201100025CNIAID NIH HHS N01 AI005419NIAID NIH HHS N01 AI025481NIAID NIH HHS UM1 AI109565NIAID NIH HHS UM2 AI117870NIDDK NIH HHS U54 DK106829
6 · The paper itself

Abstract

To ensure comparable grafts for autologous hematopoietic cell transplantation (HCT) in the National Institute of Allergy and Infectious Diseases-sponsored Investigational New Drug protocols for multiple sclerosis (HALT-MS) and systemic sclerosis (SCOT), a Drug Master File approach to control manufacture was implemented, including a common Master Production Batch Record and site-specific standard operating procedures with "Critical Elements." We assessed comparability of flow cytometry and controlled rate cryopreservation among sites and stability of cryopreserved grafts using hematopoietic progenitor cells (HPCs) from healthy donors. Hematopoietic Progenitor Cells, Apheresis-CD34+ Enriched, for Autologous Use (Auto-CD34

Indexed as

AdultAntigens, CD34BiomarkersBlood Component RemovalBlood PlateletsCell CountCell SurvivalCryopreservationFemaleGranulocytesHematopoietic Stem CellsHematopoietic Stem Cell TransplantationHumansMiddle AgedMultiple SclerosisNational Institute of Allergy and Infectious Diseases (U.S.)Antigens, CD34BiomarkersAutologous hematopoietic cell transplantationCD34 selectionClinical trialDrug master fileGraft processingMultiple sclerosisSystemic sclerosis (scleroderma)

Identifiers

PMID28602891
PMCPMC5761325

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Registered trials

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.