Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans - Randomized, double-blind, placebo-controlled study of AMG0001(HGF plasmid) for patients with arteriosclerosis obliterans

Anges MG, Inc.0 sites120 target enrollmentJune 4, 2007

ConditionsArteriosclerosis obliterans

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Arteriosclerosis obliterans
Sponsor: Anges MG, Inc.
Enrollment: 120
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Analysis of efficacy was performed in 40 patients with critical limb ischemia (CLI). 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). 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. Gene Ther. 2010 Sep;17(9):1152-61. Epub 2010 Apr 15.

Registry

who.int

Start Date

June 4, 2007

End Date

August 1, 2008

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Anges MG, Inc.

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\. Patients with a necrotized ulcer and/or an ulcer with exposed tendon or bone 2\. Patients in whom alcohol or drug dependence had been noted 90 days or less before informed consent was obtained or who had been treated for it 3\. Past history of or complication with cancer 4\. Patients with serious cardiac, hepatic, renal, or hematological disease 5\. Patients with intercurrent hepatitis B or C, AIDS, or ATL 6\. Patients who underwent revascularization or amputation (not necrotomy) 90 days or less before giving informed consent 7\. Patients who underwent sympathectomy or sympathetic block 180 days or less before giving informed consent 8\. Patients with an invasive infectious disease which is difficult to control with antibiotics 9\. Patients with proliferating diabetic retinopathy (untreated or in the middle or late stage of proliferating retinopathy) or neovascularization\-type age\-related macular degeneration 10\. Participation in another clinical trial 90 days or less before giving informed consent 11\. Pregnant or breast\-feeding women, women with suspected pregnancy, and women who desire to become pregnant during the trial 12\. Past history of cell therapy 13\. Past history of gene therapy 14\. Blood sampling (or donation) of 200 ml or more, 30 days or less before giving informed consent, or 400 ml or more, 90 (120 in the case of women) days or less before giving informed consent