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Safety and Efficacy of Immune Therapy for Condyloma

Not Applicable
Conditions
Condylomata Acuminata
Interventions
Biological: DC-CIK immunotherapy
Registration Number
NCT03158480
Lead Sponsor
Shenzhen Second People's Hospital
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
80
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo+interferon GroupDC-CIK immunotherapysaline as placebo plus interferon intervention
DC-CIK+interferon GroupDC-CIK immunotherapydendritic cell-activated cytokine-induced killer cells (DC-CIK) immunotherapy plus interferon intervention
Primary Outcome Measures
NameTimeMethod
Condylomata Acuminata recurrence rate6 months

Condylomata Acuminata recurrence rate in 6 months after treatment

Secondary Outcome Measures
NameTimeMethod
side effect6 months

evaluate and record side effect of each group

skin tissue HPV gene6 months

use PCR to testify skin tissue HPV gene

Trial Locations

Locations (1)

Shenzhen Second Hospital

🇨🇳

Shenzhen, Guangdong, China

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