Evidence map›Paper›PMID 25925838›Full record

ArticleStem cells translational medicine2015

First-in-Human Case Study: Pregnancy in Women With Crohn's Perianal Fistula Treated With Adipose-Derived Stem Cells: A Safety Study.

Raquel Sanz-Baro, Mariano García-Arranz, Hector Guadalajara, Paloma de la Quintana, Maria Dolores Herreros, Damián García-Olmo

2 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Stem cells translational medicine, 2015. 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 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
4.6field-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.

NCT04466007 phase2completednot on this mapstarted 2021, after this paper: background citation

Multicenter, Randomized, Dose-search, Parallel, Double-blind, and Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Intramuscular Administration of Allogeneic Adipose Tissue Adult Mesenchymal Stem Cells in Diabetic Patients With Critical Limb Ischemia Without Possibility of Revascularization

TypeinterventionalSponsorInstituto de Investigación Sanitaria de la Fundación Jiménez DíazRan2021 to 2024Enrolled90ConditionsLimb Ischemia, Diabetic FootArmsHigh dose allogeneic mesenchymal stromal cells, Low dose allogeneic mesenchymal stromal cells, Placebos
NCT04519697 phase1 / phase2terminatednot on this mapstarted 2020, after this paper: background citation

A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.

TypeinterventionalSponsorAnthony LemboRan2020 to 2023Enrolled20ConditionsRectovaginal Fistula, Crohn Disease, Crohn Disease of Vulva, RectolabialArmsMesenchymal Stem Cells, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. TRANSPLANTATION OF ADIPOSE-DERIVED MESENCHYMAL STEM CELLS IN REFRACTORY CROHN'S DISEASE: SYSTEMATIC REVIEW.Arquivos brasileiros de cirurgia digestiva : ABCD = Brazilian archives of digestive surgery · 2019
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  14. Therapeutic Use of Adipose-Derived Stromal Cells in a Murine Model of Acute Pancreatitis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020
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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

6 authors at 2 institutions in 1 country.

Raquel Sanz-BaroDepartment of Obstetrics and Gynecology, Cell Therapy Laboratory, Health Research Institute, and Department of Surgery, IIS-FJD Fundación Jiménez Díaz University Hospital, Madrid, Spain; Surgery Department, Autónoma University of Madrid, Madrid, Spain; Department of Colorectal Surgery, La Paz University Hospital, Madrid, Spain r.sanz.baro@gmail.com.
Mariano García-ArranzDepartment of Obstetrics and Gynecology, Cell Therapy Laboratory, Health Research Institute, and Department of Surgery, IIS-FJD Fundación Jiménez Díaz University Hospital, Madrid, Spain; Surgery Department, Autónoma University of Madrid, Madrid, Spain; Department of Colorectal Surgery, La Paz University Hospital, Madrid, Spain.
Hector GuadalajaraDepartment of Obstetrics and Gynecology, Cell Therapy Laboratory, Health Research Institute, and Department of Surgery, IIS-FJD Fundación Jiménez Díaz University Hospital, Madrid, Spain; Surgery Department, Autónoma University of Madrid, Madrid, Spain; Department of Colorectal Surgery, La Paz University Hospital, Madrid, Spain.
Paloma de la QuintanaDepartment of Obstetrics and Gynecology, Cell Therapy Laboratory, Health Research Institute, and Department of Surgery, IIS-FJD Fundación Jiménez Díaz University Hospital, Madrid, Spain; Surgery Department, Autónoma University of Madrid, Madrid, Spain; Department of Colorectal Surgery, La Paz University Hospital, Madrid, Spain.
Maria Dolores HerrerosDepartment of Obstetrics and Gynecology, Cell Therapy Laboratory, Health Research Institute, and Department of Surgery, IIS-FJD Fundación Jiménez Díaz University Hospital, Madrid, Spain; Surgery Department, Autónoma University of Madrid, Madrid, Spain; Department of Colorectal Surgery, La Paz University Hospital, Madrid, Spain.
Damián García-OlmoDepartment of Obstetrics and Gynecology, Cell Therapy Laboratory, Health Research Institute, and Department of Surgery, IIS-FJD Fundación Jiménez Díaz University Hospital, Madrid, Spain; Surgery Department, Autónoma University of Madrid, Madrid, Spain; Department of Colorectal Surgery, La Paz University Hospital, Madrid, Spain.
Hospital Universitario Fundación Jiménez Díaz · ESHospital Universitario La Paz · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledThe aim of this study was to determine whether treatment with adipose-derived stem cells (ASCs) had any influence on fertility, course of pregnancy, newborn weight, or physical condition of newborns. We performed a retrospective study of patients with a desire to become pregnant after having received intralesional injection of autologous ASCs for the treatment of perianal or rectovaginal fistula associated with Crohn's disease. We collected data on the resulting pregnancies, deliveries, and newborns of these patients. ASCs were expanded in vitro and characterized according to the international guidelines for cell surface markers (clusters of differentiation) and differentiated to adipocytes, chondrocytes, and osteocytes prior to implantation (except first implant in 2002). We analyzed five young women with Crohn's disease treated with ASCs: one for rectovaginal and perianal fistula, two for rectovaginal fistula only, and two for perianal fistula only. All patients received 2 doses of 20 million and 40 million cells at an interval of 3-4 months. Another patient received 2 doses of 6.6 million and 20 million ASCs with 9 months between each dose. Fertility and pregnancy outcomes were not affected by cell therapy treatment. No signs of treatment-related malformations were observed in the neonates by their respective pediatricians. In the patients studied, cell therapy with ASCs did not affect the course of pregnancy or newborn development. SIGNIFICANCE: Local treatment with mesenchymal stem cells derived from adipose tissue seems not to affect the ability to conceive, the course of pregnancy, pregnancy outcomes, or newborns' health in female patients. This is the first publication about pregnancy outcome in women with perianal fistula and Crohn's disease treated with stem cell therapy, and could be of interest for doctors working in cell therapy. This is a very important question for patients, and there was no answer for them until now.

Indexed as

Adipose TissueLive BirthStem CellsStem Cell TransplantationAdultAutograftsCrohn DiseaseFemaleHumansPregnancyPregnancy ComplicationsRectal FistulaVaginal FistulaAdipose-derived stem cellsCrohn’s diseasePregnancy

Identifiers

PMID25925838
PMCPMC4449097
OpenAlexW2021339649

What OpenQuestion holds

Textmetadata
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.