Status:
COMPLETED
Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)
Lead Sponsor:
BioLeaders Corporation
Conditions:
Cervical Intraepithelial Neoplasia
Eligibility:
FEMALE
20-50 years
Phase:
PHASE1
PHASE2
Brief 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).
Detailed Description
This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte. The First treatment group will be administered with BLS-ILB-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02195089
Start Date
March 1 2014
End Date
April 1 2016
Last Update
April 19 2016
Active Locations (5)
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1
Korea University Guro Hospital
Seoul, Seoul, South Korea, 152-703
2
The Dongsan Medical Center of Keimyung University
Daegu, South Korea, 700-712
3
Kwandong University College of Medicine Cheil Hospital
Seoul, South Korea, 100-380
4
The Catholic University, Korea Seoul St Mary's Hospital
Seoul, South Korea, 137-701