Lower limb ischemic disease
Conditions
Interventions
Arm 1:RGL-2102 for Injection, Multiple Doses
Arm 2:RGL-2102 for Injection, multiple doses
followed by normal saline, multiple doses
Sponsors
Beijing Luhe Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged >=20 and =70%) or occlusion of infrapopliteal arteries, with or without superficial femoral or popliteal artery involvement, confirmed by DSA or CTA within 3 months prior to randomization; 3. NRS score of rest pain in the study limb >=4 before the first dose; 4. Area of a single ulcer in the study limb =80 g/L; 2) Platelet count >=75×10?/L; 3) Neutrophil count >=1.5×10?/L; 4) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <=3×ULN, total bilirubin <=1.5×ULN; 5) Serum creatinine (Cr) <=2×ULN; 6) Glycated hemoglobin A1c (HbA1c) <=12.0%; 7. Subjects who understand the study procedures and methods, volunteer to participate, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. The study of lower limb ischemia meets any of the following conditions: (1) acute lower limb ischemia or acute exacerbation of chronic lower limb ischemia; (2) Ulcers with severe infection (cellulitis, osteomyelitis, etc.) or deep ulcers exposing the tendon or bone; (3) gangrene occurs (except local gangrene of the toes); (4) 70% or more main-iliac artery stenosis; (5) The investigator judged that the study limb was not suitable for receiving multiple intramuscular injections; (6) Revascularization surgery or sympathectomy or major amputation (amputation above ankle) within 4 weeks before signing the informed consent; 2. Have the following medical conditions or treatment history: (1) proliferative diabetic retinopathy or other proliferative retinopathy, or those who cannot be tested for retinopathy; (2) There is a history of malignant tumor, or abnormal results of any of the following tests during screening, and the researcher determines that there is a tumor risk: (a) Chest X-ray or chest CT examination; (b) alpha-fetoprotein (AFP); (c) Carcinoembryonic antigen (CEA); (d) carbohydrate antigen CA19-9 (CA19-9); (e) Carbohydrate antigen CA125 (CA125), limited to female subjects; (f) Prostate-specific antigen (PSA) for male subjects only; (g) Cervical smear test, female subjects only; (h) Mammography/ultrasound, female only; (3) have previously used gene cell therapy (including plasmid DNA, RNA, genetically modified viruses, bacteria or cells, and products based on gene editing technology, etc.) or participated in clinical trials related to gene cell therapy (except those who revealed the use of placebo); (4) Participated in clinical trials of other drug interventions other than gene cell therapy products within 3 months prior to signing the informed consent (except for screening losers), or the screening trend is within 5 half-lives of the drug (whichever is longer); (5) Levels III-IV of heart function as defined by the New York Heart Association (NYHA) (see Annex 2 for grading standards); (6) Severe liver diseases, such as decompensated cirrhosis with jaundice and ascites; (7) Patients who received surgery before signing the informed consent and are still in the postoperative risk period, and are not suitable to participate in clinical trials according to the researchers; (8) Patients with cerebral infarction (except lacunar cerebral infarction), cerebral hemorrhage, myocardial infarction, and unstable angina pectoris within 3 months before signing the informed consent; (9) Refractory hypertension (systolic blood pressure =180mmHg or diastolic blood pressure >=110mmHg after adequate antihypertensive treatment); (10) A history of drug use or drug abuse or alcohol abuse; (11) Suspected allergic history to the experimental drug or any component of the experimental drug; (12) Infectious diseases such as known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or active tuberculosis that have been determined by the investigator to be unsuitable for clinical trials: (a) Active HBV infection: Hepatitis B surface antigen (HbsAg) positive at the time of screening and HBV-DNA viral load greater than the upper limit of the normal reference range in local healthcare facilities; (b) Active HCV infection: Both HCV antibody test results and HCV-RNA test results were positive at screening. (13) Positive pregnancy test; 3. General situation: (1) Can not
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain score from baseline to Day 180;Change in ulcer area from baseline to Day 180; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactYingfeng Wu
Beijing Luhe Hospital Affiliated to Capital Medical University
Outcome results
None listed