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

Phase I treatment, single centric, randomized, intervention study on chronic HBV infected patients by autologous dendritic cell therapy in lowering serum viral load.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000234

Enrollment

Registered

2010-04-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ex vivo cultured CD14 cells: Monthly doses for six months each dose comprising of about 1 million matured dendritic cells Control Intervention1: Normal Saline: 10 ml given by iv infusio

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria Adults 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 test HBSAg positivity >3000 copies of DNA by PCR (quantitative estimation)

Exclusion criteria

Exclusion criteria: serum bilirubin >3mg% pregnancy active tuberculosis HIV seropositivity

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.Timepoint: 3 motnhs and 6 months	—

Countries

India

Contacts

Public ContactMs. Kirti Singh

Director, Institute of Cellular Therapies Private Limited

sharmin@dendriticcellresearch.com01202500195

Outcome results