Evidence map›Paper›PMID 30378681›Full record

SynthesisThe Cochrane database of systematic reviews2018

Stem cell therapy for treatment of thromboangiitis obliterans (Buerger's disease).

Daniel G Cacione, Frederico do Carmo Novaes, Daniel H Moreno

Registry-linked trialOpen access · bronzeAbstract readSystematic Review
In one paragraph

Synthesis in The Cochrane database of systematic reviews, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04661644 (A Phase 1/2a Clinical Trial to Evaluate the Efficacy and Safety of Allogenic Adipose Tissue-derived Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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.

NCT04661644 phase1 / phase2completednot on this mapstarted 2020, after this paper: background citation

A Phase 1/2a Clinical Trial to Evaluate the Efficacy and Safety of Allogenic Adipose Tissue-derived Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia

TypeinterventionalSponsorS.Biomedics Co., Ltd.Ran2020 to 2024Enrolled20ConditionsCritical Limb IschemiaArmsClusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial), Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Review
  12. Cellular therapies in no-option critical limb ischemia: present status and future directions.Postepy w kardiologii interwencyjnej = Advances in interventional cardiology · 2022
    Review
  13. Article
  14. Stem cell therapy in pain medicine.The Korean journal of pain · 2019
    Review
  15. Review
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

3 authors at 1 institution in 1 country.

Daniel G CacioneDivision of Vascular and Endovascular Surgery, Department of Surgery, UNIFESP - Escola Paulista de Medicina, Rua Borges Lagoa, 564 cj 124, Vila Clementino, São Paulo, Brazil, 04038000.
Frederico do Carmo Novaes
Daniel H Moreno
Universidade Federal de São Paulo · BR

Funding

Chief Scientist Office ETM/442
6 · The paper itself

Abstract

backgroundThromboangiitis obliterans, also known as Buerger's disease, is a non-atherosclerotic, segmental inflammatory pathology that most commonly affects the small- and medium-sized arteries, veins, and nerves in the upper and lower extremities. The etiology is unknown, but involves hereditary susceptibility, tobacco exposure, immune and coagulation responses. In many cases, there is no possibility of revascularization to improve the condition. Stem cell therapy is an option for patients with severe complications, such as ischemic ulcers or rest pain.

objectivesTo assess the effectiveness and safety of stem cell therapy in individuals with thromboangiitis obliterans (Buerger's disease). SEARCH

methodsThe Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 17 October 2017. The review authors searched the European grey literature OpenGrey Database, screened reference lists of relevant studies and contacted study authors. SELECTION CRITERIA: Randomized controlled trials (RCTs) or quasi-RCTs of stem cell therapy in thromboangiitis obliterans (Buerger's disease). DATA COLLECTION AND ANALYSIS: The review authors (DC, DM, FN) independently assessed the studies, extracted data and performed data analysis. MAIN

resultsWe only included one RCT (18 participants with thromboangiitis obliterans) comparing the implantation of stem cell derived from bone marrow with placebo and standard wound dressing care in this review. We identified no studies that compared stem cell therapy (bone marrow source) versus stem cell therapy (umbilical cord source), stem cell therapy (any source) versus pharmacological treatment and stem cell therapy (any source) versus sympathectomy. Ulcer healing was assessed in the form of ulcer size. The mean ulcer area decreased more in the stem cell implantation group: from 5.04 cm AUTHORS'

conclusionsVery low-quality evidence suggests there may be an effect of the use of bone marrow-derived stem cells in the healing of ulcers and improvement in the pain-free walking distance in patients with Buerger's disease. High-quality trials assessing the effectiveness of stem cell therapy for treatment of patients with thromboangiitis obliterans (Buerger's disease) are needed.

Indexed as

BandagesBone Marrow TransplantationHumansThromboangiitis ObliteransWalk TestWound Healing

Identifiers

PMID30378681
PMCPMC6516882
OpenAlexW2756381464

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.