Evidence map›Paper›PMID 20393508›Full record

Trial reportGene therapy2010

Randomized, double-blind, placebo-controlled clinical trial of hepatocyte growth factor plasmid for critical limb ischemia.

H Shigematsu, K Yasuda, T Iwai, T Sasajima, S Ishimaru, Y Ohashi, T Yamaguchi, T Ogihara, R Morishita

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Gene therapy, 2010. 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 69 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 4 pooled it
7.4field-weighted citation impact, top 2% 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

69 citing papers in PubMed, 4 syntheses or guidelines pooled it, 211 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Gene therapy for peripheral arterial disease.The Cochrane database of systematic reviews · 2018
    Pooled it
  4. Growth factors for angiogenesis in peripheral arterial disease.The Cochrane database of systematic reviews · 2017
    Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Postoperative Intimal Hyperplasia: Review from My Research.The International journal of angiology : official publication of the International College of Angiology, Inc · 2024
    Review
  19. Article
  20. Review

9 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

9 authors at 8 institutions in 1 country.

H ShigematsuDepartment of Vascular Surgery, Tokyo Medical University, Tokyo, Japan. hshige@tokyo-med.ac.jp
K Yasuda
T Iwai
T Sasajima
S Ishimaru
Y Ohashi
T Yamaguchi
T Ogihara
R Morishita
The University of Tokyo · JPAsahikawa Medical University · JPChubu Rosai Hospital · JPkeiyu Hospital · JPOsaka Prefectural Medical Center · JPOsaka University · JPSocial Insurance Saitama Chuo Hospital · JPTokyo Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hepatocyte growth factor (HGF) is a potent angiogenic factor. The efficacy and safety of intramuscular injection of a naked plasmid encoding human HGF gene (beperminogene perplasmid, Collategene) was investigated in patients with critical limb ischemia (CLI) in a multicenter, randomized, double-blind, placebo-controlled trial. The randomization ratio for plasmid to placebo was 2:1. Injection sites were selected in each patient limb based on angiographic findings. Placebo or plasmid was injected on days 0 and 28. Evaluation of efficacy was carried out after 12 weeks. The primary end point was the improvement of rest pain in patients without ulcers (Rutherford 4) or the reduction of ulcer size in patients with ulcer(s) (Rutherford 5). Secondary end points were ankle-brachial pressure index, amputation, and quality of life (QOL). Forty-four patients were treated, and we performed interim analysis of efficacy in 40 patients. The overall improvement rate of the primary end point was 70.4% (19/27) in HGF group and 30.8% (4/13) in placebo group, showing a significant difference (P=0.014). In Rutherford 5 patients, HGF achieved a significantly higher improvement rate (100% [11/11]) than placebo (40% [2/5]; P=0.018). HGF plasmid also improved QOL. There were no major safety problems. HGF gene therapy is safe and effective for CLI.

Indexed as

Genetic TherapyAdultDouble-Blind MethodFemaleHepatocyte Growth FactorHumansIschemiaMaleNeovascularization, PathologicPlasmidsTreatment OutcomeHepatocyte Growth FactorHGF protein, human

Identifiers

PMID20393508
OpenAlexW2010132579

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.