Safety and Biological Activity of InfraDure Biopump Secreting Sustained Interferon in HCV Patients

Medgenics Medical

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Hepatitis C

Treatments

Biological: implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01433133

MG-002-02

Details and patient eligibility

About

This will be a Phase I-II, open-label, single center, uncontrolled, dose-escalation study. The trial will be conducted in Israel at the Tel Aviv Sourasky Medical Center.

All subjects will receive autologous InfraDure Biopump (micro-organ of dermis processed ex vivo transduced with genetic construct containing the gene for interferon)tissue implants intended to provide sustained production and delivery of therapeutic levels of INF for up to twenty four (24) weeks following INFRADURE Biopump implantation. Follow up will continue for a total of two years post INFRADURE Biopump implantation

Full description

Medgenics Inc. and Medgenics Medical Israel Ltd. are developing INFRADURE, an autologous dermal biopump capable of sustained secretion of therapeutic INF in the body, using a small tissue explant from the patient's own skin. The INFRADURE biopump is produced from a micro-organ (MO), typically measuring 30 mm in length and 1.5-2.5 mm diameter, which is harvested directly from the patient's dermis under local anesthesia. The micro-organ can be viably maintained ex-vivo for extended periods of time under standard culture conditions. INFRADURE Biopumps, produced by ex vivo transduction of MOs with Helper Dependent Adenoviral INF vectors (HDAd-INF), express and secrete INF. INFRADURE Biopump is monitored ex vivo prior to re-implantation, to attain true INF dosing. The INFRADURE Biopump is subsequently implanted subcutaneously back to the patient in order to provide continuous delivery of a known amount of INF. Each implanted autologous INFRADURE Biopump remains localized under the skin, and is accessible, so that if necessary, it can be removed or ablated at any time. The entire process from harvest to implantation requires 10-14 days

Enrollment

3 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Signed patient consent form
Genotype 3 chronic HCV with detectable HCV RNA
No previous treatment for HCV infection
Hepatitis B and human immunodeficiency virus negative at screening visit
Able and willing to follow contraception requirements
Screening laboratory values, test, and physical exam within acceptable ranges

Exclusion criteria

Current enrollment in another investigational device or drug study
Anticipated inability to complete all clinic visits and comply with study procedures
History of, or any current medical condition, which could impact the safety of the subject during the study
Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
Alcoholism or substance abuse with <6 documented months of sobriety
Known allergy or sensitivity to interferons or ribavirin
Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study