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| Name | Class |
|---|---|
| Jingchu University of Technology | OTHER |
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This is an open-label and triple cohort study of the safety and efficacy of TALEN and CRISPR/Cas9 to possibly treat HPV Persistency and human cervical intraepithelial neoplasiaâ… without invasion.
HPV persistent infection is the major causal factor of cervical intraepithelial neoplasia (CIN) and cervical cancer. The important roles of E6 and E7 playing in HPV-driven carcinogenesis make them attractive targets for therapeutic interventions. Previous evidences showed that using designated TALEN and CRISPR/Cas9 as genome editing tool could produce disruption of HPV16 and HPV18 E6/E7 DNA, significantly decreasing the expression of E6/E7, inducing cell apoptosis and inhibiting cell lines growth.
This study will evaluate the safety and efficacy of TALEN-HPV E6/E7 and CRISPR/Cas9-HPV E6/E7 in treating HPV Persistency and HPV-related Cervical Intraepithelial Neoplasiaâ…
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TALEN | Experimental | TALEN (TALEN-HPV16 E6/E7 or TALEN-HPV18 E6/E7) plasmid in gel, administered twice one week for 4 weeks. |
|
| CRISPR/Cas9 | Experimental | CRISPR/Cas9 (CRISPR/Cas9-HPV16 E6/E7T1 or CRISPR/Cas9-HPV18 E6/E7T2 ）plasmid in gel, administered twice one week for 4 weeks. |
|
| Control group | No Intervention | Observation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TALEN | Biological | TALEN gel consists of TALEN plasmid, C32-447, Poloxmer 407 and distilled water as solvent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | The primary objective of this Study is to evaluate the safety of therapeutic doses and the dosing regimen of TALEN and CRISPR/Cas9 plasmid. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of HPV16 or 18 DNA titers | Blood samples will be taken at the baseline, months 3 and 6 on each subject. | Baseline, 3 and 6 months |
| Change of cervical cytological results. | ThinPrep Pap Test will be conducted at the baseline, months 3 and 6 on each subject. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Hu, M.D. | Contact | 0086+18627803527 | 18627803527@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zheng Hu, M.D. | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25136604 | Background | Hu Z, Yu L, Zhu D, Ding W, Wang X, Zhang C, Wang L, Jiang X, Shen H, He D, Li K, Xi L, Ma D, Wang H. Disruption of HPV16-E7 by CRISPR/Cas system induces apoptosis and growth inhibition in HPV16 positive human cervical cancer cells. Biomed Res Int. 2014;2014:612823. doi: 10.1155/2014/612823. Epub 2014 Jul 20. | |
| 25500889 | Background |
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open label
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| CRISPR/Cas9 | Biological | CRISPR/Cas9 gel consists of CRISPR/Cas9 plasmid, C32-447, Poloxmer 407 and distilled water as solvent. |
|
|
| Baseline, 3 and 6 months |
| Change of cervical histological results. | Colposcopy Biopsy will be conducted at the baseline and month 6 on each subject. | Baseline and 6 months. |
| Hu Z, Ding W, Zhu D, Yu L, Jiang X, Wang X, Zhang C, Wang L, Ji T, Liu D, He D, Xia X, Zhu T, Wei J, Wu P, Wang C, Xi L, Gao Q, Chen G, Liu R, Li K, Li S, Wang S, Zhou J, Ma D, Wang H. TALEN-mediated targeting of HPV oncogenes ameliorates HPV-related cervical malignancy. J Clin Invest. 2015 Jan;125(1):425-36. doi: 10.1172/JCI78206. Epub 2014 Dec 15. |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D000069896 | Transcription Activator-Like Effector Nucleases |
| D000076987 | CRISPR-Associated Protein 9 |
| ID | Term |
|---|---|
| D004706 | Endodeoxyribonucleases |
| D003851 | Deoxyribonucleases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D011993 | Recombinant Fusion Proteins |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004720 | Endonucleases |
| D001426 | Bacterial Proteins |
| D064130 | CRISPR-Associated Proteins |
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