Evidence map›Paper›PMID 21680720›Full record

Trial reportDiabetes care2011

Phase I (safety) study of autologous tolerogenic dendritic cells in type 1 diabetic patients.

Nick Giannoukakis, Brett Phillips, David Finegold, Jo Harnaha, Massimo Trucco

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02903537 (Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients), which is not on this map. Cited by 239 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
239citing papers in PubMed, 1 pooled it
11.0field-weighted citation impact, top 1% 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.

NCT02903537 phase1unknown statusnot on this mapstarted 2017, after this paper: background citation

Tolerance-Induction With Dendritic Cells Treated With Vitamin-D3 and Loaded With Myelin Peptides, in Multiple Sclerosis Patients (TOLERVIT-MS)

TypeinterventionalSponsorFundació Institut Germans Trias i PujolRan2017 to 2023Enrolled16ConditionsMultiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Chronic ProgressiveArmsAutologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3), Interferon-beta
3 · Its place in the literature

Who cites it

239 citing papers in PubMed, 1 synthesis or guideline pooled it, 397 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Cell Therapy for Type 1 Diabetes Mellitus: a Review of Clinical Trials.Bulletin of experimental biology and medicine · 2025
    Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. The Biology of Dendritic Cells: In Health and Disease.Advances in experimental medicine and biology · 2025
    Review
  20. Review

179 more citing papers are in PubMed but not listed here.

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 at 1 institution in 1 country.

Nick GiannoukakisDepartment of Pediatrics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Brett Phillips
David Finegold
Jo Harnaha
Massimo Trucco
University of Pittsburgh · US

Funding

Gene-engineered dendritic cell therapy for diabeticsR33DK063499 · NIDDK · CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS · PI TRUCCO, MASSIMO M. · 2005 to 2006
$1.0M
NIDDK NIH HHS R33 DK063499NIDDK NIH HHS R33-DK-63499-03
6 · The paper itself

Abstract

objectiveThe safety of dendritic cells to selectively suppress autoimmunity, especially in type 1 diabetes, has never been ascertained. We investigated the safety of autologous dendritic cells, stabilized into an immunosuppressive state, in established adult type 1 diabetic patients. RESEARCH DESIGN AND

methodsA randomized, double-blind, phase I study was conducted. A total of 10, otherwise generally healthy, insulin-requiring type 1 diabetic patients between 18 and 60 years of age, without any other known or suspected health conditions, received autologous dendritic cells, unmanipulated or engineered ex vivo toward an immunosuppressive state. Ten million cells were administered intradermally in the abdomen once every 2 weeks for a total of four administrations. The primary end point determined the proportion of patients with adverse events on the basis of the physician's global assessment, hematology, biochemistry, and immune monitoring for a period of 12 months.

resultsThe dendritic cells were safely tolerated. There were no discernible adverse events in any patient throughout the study. Other than a significant increase in the frequency of peripheral B220+ CD11c- B cells, mainly seen in the recipients of engineered dendritic cells during the dendritic cell administration period, there were no statistically relevant differences in other immune populations or biochemical, hematological, and immune biomarkers compared with baseline.

conclusionsTreatment with autologous dendritic cells, in a native state or directed ex vivo toward a tolerogenic immunosuppressive state, is safe and well tolerated. Dendritic cells upregulated the frequency of a potentially beneficial B220+ CD11c- B-cell population, at least in type 1 diabetes autoimmunity.

Indexed as

AdolescentAdultDendritic CellsDiabetes Mellitus, Type 1Double-Blind MethodFemaleHumansImmunosuppression TherapyInsulinMaleMiddle AgedTransplantation, AutologousYoung AdultInsulin

Identifiers

PMID21680720
PMCPMC3161299
OpenAlexW2117477752

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.