Evidence map›Paper›PMID 32864818›Full record

Trial reportStem cells translational medicine2020

Two phase I/II clinical trials for the treatment of urinary incontinence with autologous mesenchymal stem cells.

Mariano Garcia-Arranz, Sergio Alonso-Gregorio, Pamela Fontana-Portella, Elena Bravo, Jesus Diez Sebastian, María Eugenia Fernandez-Santos, Damian Garcia-Olmo

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Stem cells translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07104981 (Retrospective Evaluation of the Efficacy and Safety of Micronized Adipose Tissue Obtained With the Matrigen Device in the Treatment of Patients With Interstitial Cystitis), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT07104981 completednot on this mapstarted 2024, after this paper: background citation

Retrospective Evaluation of the Efficacy and Safety of Micronized Adipose Tissue Obtained With the Matrigen Device in the Treatment of Patients With Interstitial Cystitis

Typeobservational_patient_registrySponsorUniversity of Roma La SapienzaRan2024 to 2025Enrolled20ConditionsInterstitial Cystitis/Painful Bladder SyndromeArmsMesenchymal Stem Cell Transplantation
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it, 37 citations in OpenAlex.

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  10. Improved Sphincter Muscle Regeneration by Myoblasts fromMedical sciences (Basel, Switzerland) · 2026
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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

7 authors at 4 institutions in 1 country.

Mariano Garcia-ArranzNew Therapies Laboratory, Health Research Institute-Fundación Jiménez Díaz University Hospital (IIS-FJD), Madrid, Spain.ORCID 0000-0002-6266-9055
Sergio Alonso-GregorioDepartment of Urology, Hospital De la Cruz Roja San José y Santa Adela, Madrid, Spain.
Pamela Fontana-PortellaDepartment of Urology, La Paz University Hospital, Madrid, Spain.
Elena BravoDepartment of Plastic Surgery, La Paz University Hospital, Madrid, Spain.
Jesus Diez SebastianStatistics Department, La Paz University Hospital, Madrid, Spain.
María Eugenia Fernandez-SantosGMP-Cell Production Unit, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), Madrid, Spain.
Damian Garcia-OlmoNew Therapies Laboratory, Health Research Institute-Fundación Jiménez Díaz University Hospital (IIS-FJD), Madrid, Spain.
Hospital Universitario La Paz · ESHospital Universitario Fundación Jiménez Díaz · ESHospital Central de la Cruz Roja San José y Santa Adela · ESHospital General Universitario Gregorio Marañón · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We evaluated the safety and feasibility of adipose-derived mesenchymal stem cells to treat endoscopically urinary incontinence after radical prostatectomy in men or female stress urinary. We designed two prospective, nonrandomized phase I-IIa clinical trials of urinary incontinence involving 9 men (8 treated) and 10 women to test the feasibility and safety of autologous mesenchymal stem cells for this use. Cells were obtained from liposuction containing 150 to 200 g of fat performed on every patient. After 4 to 6 weeks and under sedation, endoscopic intraurethral injection of the cells was performed. On each visit (baseline, 1, 3, 6, and 12 months), clinical parameters were measured, and blood samples, urine culture, and uroflowmetry were performed. Every patient underwent an urethrocystoscopy and urodynamic studies on the first and last visit. Data from pad test, quality-of-life and incontinence questionnaires, and pads used per day were collected at every visit. Statistical analysis was done by Wilcoxon signed-rank test. No adverse effects were observed. Three men (37.5%) and five women (50%) showed an objective improvement of >50% (P < .05) and a subjective improvement of 70% to 80% from baseline. In conclusion, intraurethral application of stem cells derived from adipose tissue is a safe and feasible procedure to treat urinary incontinence after radical prostatectomy or in female stress urinary incontinence. A statistically significant difference was obtained for pad-test improvement in 3/8 men and 5/10 women. Our results encourage studies to confirm safety and to analyze efficacy.

Indexed as

AgedFemaleHumansMaleMesenchymal Stem CellsMesenchymal Stem Cell TransplantationMiddle AgedUrinary Incontinenceadipose-derived stem cellscellular therapymale/female urinary incontinencephase IIa clinical trial

Identifiers

PMID32864818
PMCPMC7695632
OpenAlexW3082814429

What OpenQuestion holds

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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.