Evidence map›Paper›PMID 23429460›Full record

ArticleInflammatory bowel diseases

Safety and tolerability of human placenta-derived cells (PDA001) in treatment-resistant crohn's disease: a phase 1 study.

Lloyd Mayer, William M Pandak, Gil Y Melmed, Stephen B Hanauer, Kristine Johnson, Denise Payne, Herbert Faleck, Robert J Hariri, Steven A Fischkoff

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Inflammatory bowel diseases. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 7% 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

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Trial
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  7. Article
  8. The Impact of Cellular Therapies on Gastrointestinal Diseases: Applications and Challenges.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2023
    Review
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  13. Basic and Preclinical Research for Personalized Medicine.Journal of personalized medicine · 2021
    Review
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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

9 authors at 4 institutions in 1 country.

Lloyd MayerMount Sinai School of Medicine, New York, NY 10029, USA. lloyd.mayer@mssm.edu
William M Pandak
Gil Y Melmed
Stephen B Hanauer
Kristine Johnson
Denise Payne
Herbert Faleck
Robert J Hariri
Steven A Fischkoff
Cedars-Sinai Medical Center · USMount Sinai Hospital · USUniversity of Chicago Medical Center · USVirginia Commonwealth University · US

Funding

THE ROLE OF ICSBP IN MUCOSAL IMMUNE RESPONSEP01DK072201 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HARPAZ, NOAM · 2006 to 2015
$14.6M
BLRD VA I01 BX000197NIDDK NIH HHS P01 DK072201
6 · The paper itself

Abstract

backgroundThe clinical utility of cellular therapies is being investigated in a broad range of therapeutic areas. This phase 1 study represents the first exploration of PDA001, a preparation of cells cultured from human placental tissue, in subjects with Crohn's disease.

methodsTwelve subjects with active, moderate-to-severe Crohn's disease unresponsive to previous therapy were given 2 intravenous infusions of PDA001 1 week apart, monitored weekly for 5 weeks, and assessed at 6 months, 1 year, and 2 years after infusion. Six subjects received 2 infusions of 2 × 10 cells (low dose), and 6 subjects received 2 infusions of 8 × 10 cells (high dose).

resultsMean baseline Crohn's Disease Activity Index in the low-dose and high-dose groups was 305 and 364, respectively, and mean C-reactive protein was 8 mg/L and 49 mg/L, respectively. All subjects in the low-dose group achieved a clinical response (a Crohn's Disease Activity Index decrease of ≥70 points versus baseline), and 3 achieved remission (a Crohn's Disease Activity Index decrease of ≥100 to <150 points). Two subjects in the high-dose group achieved response, and none met remission criteria. Most adverse events were mild to moderate in severity and included headache, nausea, fever, and infusion site reactions.

conclusionsPDA001 infusions appear safe and well-tolerated in subjects with treatment-resistant Crohn's disease. A response was seen in all subjects in the low-dose group. The high-dose group, with a higher baseline disease activity, had only 2 responders, suggesting a more treatment-resistant population. A phase 2 study in this patient population is ongoing.

Indexed as

Cell- and Tissue-Based TherapyAdolescentAdultAgedAged, 80 and overCells, CulturedCrohn DiseaseFemaleHumansMaleMaximum Tolerated DoseMiddle AgedPlacentaPregnancyRemission InductionSalvage Therapy

Identifiers

PMID23429460
PMCPMC4272923
OpenAlexW2315028478

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.