Evidence map›Paper›PMID 23611977›Full record

Trial reportBiology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation2013

Autologous umbilical cord blood infusion followed by oral docosahexaenoic acid and vitamin D supplementation for C-peptide preservation in children with Type 1 diabetes.

Michael J Haller, Clive H Wasserfall, Maigan A Hulme, Miriam Cintron, Todd M Brusko, Keiran M McGrail, John R Wingard, Douglas W Theriaque, Jonathan J Shuster, Ronald J Ferguson and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 6 pooled it
4.4field-weighted citation impact, top 5% 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

26 citing papers in PubMed, 6 syntheses or guidelines pooled it, 59 citations in OpenAlex.

  1. Pooled it
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  16. The Future State of Newborn Stem Cell Banking.Journal of clinical medicine · 2019
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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

14 authors at 1 institution in 1 country.

Michael J HallerDepartment of Pediatrics, the University of Florida, Gainesville, FL 32610, USA. hallemj@peds.ufl.edu
Clive H Wasserfall
Maigan A Hulme
Miriam Cintron
Todd M Brusko
Keiran M McGrail
John R Wingard
Douglas W Theriaque
Jonathan J Shuster
Ronald J Ferguson
Marianne Kozuch
Michael Clare-Salzler
Mark A Atkinson
Desmond A Schatz
University of Florida · US

Funding

WHITE MATTER AND COGNITION IN PARKINSON'S DISEASEM01RR000082 · NCRR · UNIVERSITY OF FLORIDA · PI BYRNE, BARRY J · 1985 to 2009
$29.7M
UF Clinical and Translational Science AwardUL1TR000064 · NCATS · UNIVERSITY OF FLORIDA · PI NELSON, DAVID R · 2012 to 2014
$12.2M
Cord Blood Immunoregulation of Type 1 DiabetesR21DK077580 · NIDDK · UNIVERSITY OF FLORIDA · PI ATKINSON, MARK A. · 2006 to 2007
$388k
NCATS NIH HHS UL1 TR000064NCATS NIH HHS UL1TR000064NCRR NIH HHS M01 RR000082NCRR NIH HHS M01RR00082NIDDK NIH HHS 1R21DK077580-01NIDDK NIH HHS R21 DK077580
6 · The paper itself

Abstract

We sought to determine if autologous umbilical cord blood (UCB) infusion followed by 1 year of supplementation with vitamin D and docosahexaenoic acid (DHA) can preserve C-peptide in children with type 1 diabetes. We conducted an open-label, 2:1 randomized study in which 15 type 1 diabetes subjects with stimulated C-peptide > .2 pmol/mL received either (1) autologous UCB infusion, 1 year of daily oral vitamin D (2000 IU), and DHA (38 mg/kg) and intensive diabetes management or (2) intensive diabetes management alone. Primary analyses were performed 1 year after UCB infusion. Treated (N = 10) and control (N = 5) subjects had median ages of 7.2 and 6.6 years, respectively. No severe adverse events were observed. Although the absolute rate of C-peptide decline was slower in treated versus control subjects, intergroup comparisons failed to reach significance (P = .29). Area under the curve C-peptide declined and insulin use increased in both groups (P < .01). Vitamin D levels remained stable in treated subjects but declined in control subjects (P = .01). DHA levels rose in treated subjects versus control subjects (P = .003). CD4/CD8 ratio remained stable in treated subjects but declined in control subjects (P = .03). No changes were seen in regulatory T cell frequency, total CD4 counts, or autoantibody titers. Autologous UCB infusion followed by daily supplementation with vitamin D and DHA was safe but failed to preserve C-peptide. Lack of significance may reflect small sample size. Future efforts will require expansion of specific immunoregulatory cell subsets, optimization of combined immunoregulatory and anti-inflammatory agents, and larger study cohorts.

Indexed as

Cord Blood Stem Cell TransplantationAdministration, OralArea Under CurveCase-Control StudiesCD4 Lymphocyte CountChildChild, PreschoolC-PeptideDiabetes Mellitus, Type 1Docosahexaenoic AcidsFemaleHumansInfantInfusions, IntravenousMaleT-Lymphocyte SubsetsC-PeptideDocosahexaenoic AcidsVitamin D

Identifiers

PMID23611977
PMCPMC3852705
OpenAlexW2158020943

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.