Safety & Biological Activity of InfraDure Biopump Secreting Sustained

Status Terminated

Clinical Trial 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

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01433133
Study type	Interventional
Source	Medgenics Medical Israel Ltd.
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	October 2012
Completion date	March 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03686722` - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin	Phase 1
Recruiting	`NCT04510246` - Link Hepatitis C Notifications to Treatment in Tasmania	N/A
Completed	`NCT03413696` - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed	`NCT03109457` - Hepatitis C Virus Detection in Oral Squamous Cell Carcinoma
Completed	`NCT03118674` - Harvoni Treatment Porphyria Cutanea Tarda	Phase 2
Completed	`NCT01458054` - Effect of Omeprazole and Ritonavir on GSK2336805 Pharmacokinetics in Healthy Adults	Phase 1
Completed	`NCT03740230` - An Observational Study of Maviret (Glecaprevir/Pibrentasvir) for Korean Chronic Hepatitis C Genotypes 1 to 6 Patients According to the Standard for Re-examination of New Drugs
Completed	`NCT03426787` - Helping Empower Liver and Kidney Patients	N/A
Completed	`NCT03627299` - Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors	Phase 4
Completed	`NCT00006301` - Immune Response to Hepatitis C Virus
Active, not recruiting	`NCT03949764` - The Kentucky Viral Hepatitis Treatment Study	Phase 4
Completed	`NCT03365635` - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C	Phase 4
Recruiting	`NCT04405024` - Pilot Study on the Feasibility of Systematic Hepatitis C Screening of Hospitalized Patients	N/A
Completed	`NCT04525690` - Improving Inpatient Screening for Hepatitis C	N/A
Completed	`NCT04033887` - Evaluation Study of RDTs Detecting Antibodies Against HCV
Withdrawn	`NCT04546802` - HepATocellular Cancer Hcv Therapy Study	Phase 3
Active, not recruiting	`NCT02961426` - Strategic Transformation of the Market of HCV Treatments	Phase 2/Phase 3
Completed	`NCT03186313` - A Study to Evaluate the Safety and Efficacy of the Combined Single Dose of Dactavira Plus Or Dactavira in Egyptian Adults With Chronic Genotype 4 HCV Infection	Phase 3
Completed	`NCT02705534` - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1	Phase 3
Completed	`NCT02869776` - Integrating HCV and HIV Screening During the Era of HIV Antigen Testing	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms