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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01433133
Recruitment Status : Terminated (Company strategic decision)
First Posted : September 13, 2011
Last Update Posted : September 13, 2016
Information provided by (Responsible Party):
Medgenics Medical Israel Ltd.

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Hepatitis C Biological: implantation Phase 1 Phase 2

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I-II, Open Label, Uncontrolled, Dose Escalation Study of the Safety, Tolerability and Biologic Activity of the INFRADURE Biopump Secreting Sustained Interferon Alpha-2b (IFNα), in Combination With Oral Ribavirin for Genotype 3 Newly Diagnosed Hepatitis C Patients
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
• Genotype 3 chronic HCV with detectable serum HCV RNA
Biological: implantation
subcutaneous implantation of autologous dermis implant treated ex vivo with genetic vector carrying the gene for interferon alfa 2b

Primary Outcome Measures :
  1. Viral Load: incidence of sustained virologic response (SVR) [ Time Frame: 24 weeks ]
    Viral load to be measured along the study expecting notable decrease in the viral load by week 24 post intervention

Secondary Outcome Measures :
  1. Rapid virologic response (RVR) [ Time Frame: Time Frame-Study Week 4 ]
  2. Early virologic response (EVR) [ Time Frame: Time Frame-Study week 12 ]
  3. End-of-treatment response (EOT) [ Time Frame: Time Frame-Study week 48, 104 ]
  4. Rapid virologic response (RVR) [ Time Frame: Evaluation after 4 weeks from treatment day 0 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Responsible Party: Medgenics Medical Israel Ltd. Identifier: NCT01433133     History of Changes
Other Study ID Numbers: MG-002-02
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs