Treatment of hepatitis B carriers by immune cell therapy maturing their own WBC(CD14) cells for treatment

Phase 1

• Conditions: Chronic Hepatitis B Carriers having HBSAg positive status, HBV DNA positive status

• Registration Number: CTRI/2010/091/000234
• Lead Sponsor: Institute of Cellular Therapies Private Limited

Brief Summary

This study is a randomised,single blinded,parallel group,single centeric trial determining safety and efficacy of autologous dendritic cells (about 1 million in number) for 6 months in 10 chronic Hepatitis B carriers.The objective of this study is to see whether administartion of autologous dendritic cells at doses of 1 million cells via interavenous route is: 1. safe. 2. To find out efficacy of theraputic dose. 3. Can clear infection of HBV DNA. Carriers will be evaluated at 7 days for safety, 1 month for safety 3 month for safety and efficacy, 6 month for safety and efficacy parameters.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Inclusion CriteriaAdults Males or females aged above 18 till 60 years of age with diagnosis of chronic hepatitis B infection for past 6 months, proven by elisa and pcr testHBSAg positivity>3000 copies of DNA by PCR (quantitative estimation).

Exclusion Criteria

serum bilirubin >3mg%pregnancyactive tuberculosisHIV seropositivity.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability, assessed by adverse events. The type of AE(S), Number of AE(S) and proportion of Patients with AE(S)	Baseline, 1st day, seventh day, one month,three months and six months

Secondary Outcome Measures

Name	Time	Method
Serum Level of HBSAg(quantitative analysis), HBV DNA estimation by PCR (quantitative status- whether it has reached to less than 300 per ml of serum.	3 motnhs and 6 months

Trial Locations

Locations (1)

Institute of Cellular Therapies Private Limited; 🇮🇳 Sector, India

Institute of Cellular Therapies Private Limited

🇮🇳Sector, India

Dr. Sharmin Yaqin

Principal investigator

01202500195

sharmin@dendriticcellresearch.com