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NCT03158480 Clinical Trial

Safety and Efficacy of Immune Therapy for Condyloma

Condylomata Acuminata Clinical Trial

Official title:
Safety and Efficacy of Immune Therapy for Condyloma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03158480
Other study ID # 20173357201827
Secondary ID
Status Recruiting
Phase N/A
First received May 16, 2017
Last updated June 28, 2017
Start date June 25, 2017
Est. completion date June 30, 2019

Study information
Verified date March 2017
Source Shenzhen Second People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cytokine-induced killer (CIK) cells will be co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to Condylomata Acuminata patients using interferon, whose recurrence rate and total cost will be compared to Condylomata Acuminata patients only use interferon.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date June 30, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:All patients have typical clinical characters of condyloma, positive for HPV-DNA test; All patients have been treated for cryotherapy or laser plus interferon for over half a year without completely recovery. All patients or their family will sign informed consent and approved by Ethics Committee of Shenzhen Second People's Hospital -

Exclusion Criteria:pregnant, blood disease, contraindication for immune therapy, allergic to interferon

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• DC-CIK immunotherapy
Cytokine-induced killer (CIK) cells are co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to condylomata acuminata patients

Locations
Country Name City State
China Shenzhen Second Hospital Shenzhen Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Shenzhen Second People's Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Condylomata Acuminata recurrence rate Condylomata Acuminata recurrence rate in 6 months after treatment 6 months
Secondary skin tissue HPV gene use PCR to testify skin tissue HPV gene 6 months
Secondary side effect evaluate and record side effect of each group 6 months
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