Angiogenic Gene Therapy with HGF Gene

JRCT ID: jRCTs053180162

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Peripheral Arterial Disease
• Date of first enrollment: 24/09/2014
• Target sample size: 6
• Study type: Interventional
• Intervention(s): An AMG0001 formulation (2.5 mg/ml, 2.1 ml/vial) will be prepared before use and administered to 8 sites with ischemia in the target limb, 0.5 mg of AMG0001 per site (total dose: 4.0 mg).

Outcome(s)

Primary Outcome

Pain at rest
ulcer

Secondary Outcome

1.Efficacy
1)Pain at rest
2)Ulcer
3) ABI (ankle-brachial systolic pressure index)
4)Fontaine classification
5)Frequency of analgesics-free patients
2.Safety
Adverse events , Adverse reaction , Serious adverse events by referring to vital sings , physical examination , laboratory test , urine test , ECG .

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 85age old
• Gender: Both

Include criteria

1.Patients who personally give informed consent in writing
2.Patients aged 20 or older but younger than 85
3.Patients who have a stenosis or occlusion in superficial femoral artery, popliteal artery, or artery below the popliteal of the treated limb confirmed by MRA or CTA.
4.The mean ankle pressure is less than 70 mmHg or ABI is not more than 0.6 during the observation period. (However, this shall not apply in the case of Buerger's disease.)
5.Those who have the following clinical symptoms due to stenosis or occlusion.
Rest pain (Fontaine III ) VAS is at least 20mm during the observation period
Ulcer (Fontaine IV )
6.Patients in whom revascularization in the treated limb is difficult, or patients who are determined that the adaptation is not impossible but there are some risks in surgery
7.Patients showing no symptom of improvement in the treated limb despite the conduct of conventional medical treatment or intervention for more than two weeks in the observation period after obtaining informed consent. The conventional medical treatment or intervention needs to be continued more than two weeks before obtaining the informed consent.
8.Patients who agree to contraception by a sperm passage blocking method until the end of Week 12 of treatment after obtaining informed consent
9.Inpatient, outpatient allowed

Exclude criteria

1.Patients with a necrotized ulcer and/or an ulcer with exposed tendon or bone in the treated or non-treated limb
2.Patients in whom alcohol or drug dependence had been noted 90 days or less before obtaining informed consent
3.Patient with malignant tumor history or merger. Patients with no recurrence of breast cancer more than 10 years, and with no recurrence of all other tumor types before obtaining informed consent, may be enrolled in the clinical research. Patients must been completed the cancer screening tests as defined in the protocol.
4.Patient with serious cardiac, renal or hematological disease, but excluding plateau chronic maintenance dialysis patients.
5.Patients with HIV antigen or antibody positive
6.Patients who underwent revascularization or amputation in the treated or non-treated limb, excluding small incision, necrotomy or onychectomy etc.
7.Patients who underwent sympathectomy or sympathetic block 90 days or less before obtaining informed consent
8.Patients with an invasive infectious disease which is difficult to control with antibiotics
9.Patients with proliferative diabetic retinopathy of untreated or treatment-resistant, or patients with neovascularization-type age-related macular degeneration
10.Patients with diabetic neuropathy (diffuse symmetrical neuropathy)
11.Participation in another clinical trial 30 days or less before obtaining informed consent
12.Past history of gene therapy excluding AMG0001
13.Pregnant or breast-feeding women, women with suspected pregnancy, and women who desire to become pregnant during the clinical research
14.Patients who were judged to be unsuitable for the clinical research by the attending physician

Related Information

• Primary Sponsor: Rakugi Hiromi
• Source(s) of Monetary Support: AnGes, Inc
• Secondary ID(s): UMIN000014918