Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioLeaders Corporation
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Pre-menopausal patients between age of 20 and 50.

• Patients with cervical intraepithelial neoplasia 3(CIN3).

• Only infection with HPV type 16.

• Patients with Capable of observation of all of lesions by Colposcopy biopsy.

• Be informed of the nature of the study and will give written informed consent.

• Be agree with contraception during study

• White Blood Cell Count(WBC) over 4thous/ul, Hemoglobin above over 9.0g/dL Platelet over 150thous/uL and ANC(Absolute Neutrophil Count) over 1,500 /mm^3

• Normal for EKG(Electrocardiography)

• AST/ALT : 2.5 times less than normal range

Exclusion Criteria:

• Autoimmune Disease or Prohibited drug(Therapy) bring about immunosuppressive.

• Patient that has medical history of hypersensitivity about Food containing Lactic acid bacteria or Lactic acid bacteria medication.

• Patient with Acute illness(ex. Acute Appendicitis, Myocardial infarction, Hemorrhage, meningitis etc.)

• Investigational product within three months before the start of the drug administration to patients treated with other test drug.

• Patient with Chronic pancreatitis currently or Patients diagnosed with acute pancreatitis.

• Organopathy Patient with Inflammatory intestine·bowel disease, gastrointestinal tumors, ulcers, bleeding, perforation etc.

• Pregnant or lactating women

• Patient with HBV or HCV infection (except for Asymptomatic)

• Patient that Investigator judge

• Deemed inappropriate for researchers to judge the patient