This is an single arm clinical study of the safety and efficacy of T512 to possibly treat cervical intraepithelial neoplasia(CIN).
Persistent infection with high-risk human papillomavirus (HPVs),especially types 16 and 18,may lead to cervical intraepithelial neoplasia(CIN).HPVs expresses the oncoproteins E6 and E7, both of which play key roles in maintaining viral infection and promoting carcinogenesis. Previous studies showed that using designated TALENs (T27 and T512) targeted HPV16 E6 and E7 produced disruption of HPV16 E6 and E7 DNA, decreased the expression of E6 and E7 proteins, and induced cell apoptosis. This study will evaluate the safety and efficacy of and T512 in treating HPV Persistency and HPV16-positive CIN.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
T512 suppository contain 500 µg of T512 and suppocire.
Tongji Hospital
Wuhan, Hubei, China
RECRUITINGSafety-Number of participants with Adverse Events
Number of participants who report adverse events as a measure of safety
Time frame: 6 months
Change of HPV16 DNA titers
Blood samples will be taken at the indicated times
Time frame: Baseline, 3 and 6 months
Number of dysplastic cells mearsured by ThinPrep Pap Test
From high-grade squamous intraepithelial lesion (HSIL) to Low-grade Squamous Intraepithelial Lesion (LSIL), or from LSIL to negative
Time frame: Baseline, 3 and 6 months
Change of cervical histological results
Colposcopy Biopsy will be conducted at the baseline and month 6 on each subject
Time frame: Baseline and 6 months
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