Safety and Efficacy of Immune Therapy for Condyloma

Shenzhen University

Status: Unknown

Conditions: Condylomata Acuminata

Treatments: Biological: DC-CIK immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03158480

20173357201827

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

DC-CIK+interferon Group

Experimental group

Description:

dendritic cell-activated cytokine-induced killer cells (DC-CIK) immunotherapy plus interferon intervention

Treatment:

Biological: DC-CIK immunotherapy

Placebo+interferon Group

Placebo Comparator group

Description:

saline as placebo plus interferon intervention

Treatment:

Biological: DC-CIK immunotherapy