Expertise

Biologic products present special scientific, manufacturing and regulatory challenges. TheraGenesis’ staff experience in the management of the clinical and regulatory development of biologic products, include a variety of recombinant, cellular implant and vaccine products:

Dependent upon the nature and claims sought for nutritional products, products are regulated through food legislation or drug legislation. TheraGenesis staff have provided consultancy and operational support, including clinical evaluation, to clients for the following types of nutritional products:

An Observational Study of the Performance and Safety of a Left Atrial Appendage Exclusion System.

A Pilot Randomised Controlled Trial of the Use of an Autologous Cell Harvesting Device for Venous Leg Ulcers.

A randomized, double-blind, placebo-controlled trial of an iron-chelation drug in patients with pantothenate kinase-associated neurodegeneration (PKAN).

Evaluation of a Cold Plasma Technology as a Method for Surgical Incision Closure following Caesarian Section.

Gelatin Sponge Application in Venous Insufficiency Treatment Study.

Evaluation of a Second Generation High Definition and Narrow Band Imaging Colonoscopy System for the Detection and Characterization of Colorectal Adenomas – A European Multi-Center Study.

A Prospective Randomized Study of Endovascular Treatment (Liberation Procedure) of Chronic Cerebrospinal Venous Insufficiency in Patients with Multiple Sclerosis.

In-Tunnel European PFO Trial: A Prospective, Multi-Center Study to Evaluate the Safety and Performance of a PFO Closure System.

ASA Plavix Feasibility Study with a Left Atrial Appendage Closure Technology.

Continued Access PROTECT AF Registry – CAP Registry – US IDE PIVOTAL Clinical Study.

Pilot Study to Evaluate the Safety and Performance of an Orbital Atherectomy System in Treating De Novo Coronary Lesions.

A Study of the Effect of a Percutaneous ArterioVenous Fistula System (System A) on Excercise Capacity and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease (COPD).

A Study of the Effect of a Percutaneous ArterioVenous Fistula System (System B) on Excercise Capacity and Quality of Life in Patients with Chronic Obstructive Pulmonary Disease (COPD).

A Feasibility Study of Temporary Bronchial Epicardial Stimulation for Cardiac Pacing Application.

Evaluation of Safety and Feasibility of a Cryotherapy Device for office-based Ultrasound-guided Treatment of Breast Fibroadenoma.

APOLO – Accessing Peripheral Occluded LessiOns – Prospective, Feasibility, Non-Randomized Clinical Study.

A Prospective, Unmasked, Cross-Over Evaluation of an Intraocular Stent in Patients with Primary Open-Angle Glaucoma.

A Prospective, Unmasked, Randomized Evaluation of an Intraocular Stent Versus Two Ocular Hypotensive Agents in Patients with Primary Open-Angle Glaucoma.

A Multi-Center Study of a Urethral Sling for the Treatment of Male Urinary Incontinence.

Study of a Trabecular Microstent in Subjects with Open Angle Glaucoma.

Multicenter European Study to Evaluate the Performance and Safety of an Anterior Chamber Implant in Glaucoma Patients.

Phase IV Clinical Experience Study to Evaluate a Biotech Product in the Treatment of Recalcitrant Wounds

Post-Marketing, Multicenter Study to evaluate a Single Dose of a Wound-Healing Product Every Other Day in the Treatment of Venous and Arterio-Venous Wounds.

Multicenter European Study to Evaluate the Performance and Safety of a Hypothermia Induction System in The Minimization of Neurological Deficit in Patients following Cardiac Arrest and Resusitation.

Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation (PROTECT AF) – A US IDE Pivotal Clinical Study.

Evaluation of The Safety and Performance of a Left Ventricular Assist Device In Patients Requiring Hemodynamic Support.

A Clinical Study to Evaluate the Safety and Efficacy of a Cardiac Cryoablation System for the Treatment of Paroxysmal Atrial Fibrillation.

A Multi-Center Study of a Urethral Sling for the Treatment of Female Urinary Incontinence.

A Multi-Center Study of an Ultrasound Catheter System and Pharmacologic Lysis in Thrombotic Stroke.

Online Localization of the Position of the Prostate and Possible Repositioning in Intensity Modulated Radiotherapy Supported by Pictures (IGRT) of the Prostate using an Implanted Radio Transmitter.

A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase 2 Study to Evaluate the Efficacy and Safety of a Pharmaceutical Administered for 12 Weeks in HIV‑infected Patients With HIV‑associated Visceral Obesity.

A Multi-Center Study of an Implantable Left Atrial Appendage Filter System for the Prevention of Ischemic Stroke.

A Multicenter, Randomised, Controlled Therapy Study to Evaluate Heroin Administration and Psychotherapeutic Support in Opiate Addicted Patients.

Multicenter, Non-Randomised, Prospective, Feasibility and Safety Clinical Study of an Embolic Protection Device During Transluminal Intervention in the Coronary Vessels.

An Open-Label Study to Evaluate the Performance and Safety of Device for the Continuous Monitoring of Intrapartum Fetal Oxygen Saturation and Fetal Heart Rate.

Extracorporeal Whole Body Hyperthermia in the Treatment of AIDS, Hepatis C and in Oncology.

A Prospective Evaluation of a Mechanical Anastomosis Device for Aortic Autologous Vein Grafts.

Cardiac Implant to Induce Ventricular Shape Change to Improve Myocardial Contraction Efficiency in Severe Congestive Heart Failure.

An Open-Label, Single Cross-Over Design Study to Determine the Clastogenic Potential of Two Iron Chelation Medications in Iron-Overloaded, Transfusion Dependent Thalasemia Patients.

Evaluation of a Transcatheter Atrial Septal Defect Occluder in the Treatment of Atrial Septal Defect and Persistent Foramen Ovalis: An International Closure Trial.

Treatment of Severe Ischemic Heart Disease with Transmyocardial Laser Revascularization: A Multinational Evaluation.

Treatment of Severe Ischemic Heart Disease with Percutaneous Transmyocardial Laser Revascularization: A Multinational Evaluation.

Safety and Efficacy of Two Therapy Regimens of Iron Chelation in the Treatment of Iron Overload in Thalassemia Patients.

Internal Mammary Artery Mobilisation Study using Robotic Endoscopic Technology.

European Trial Study for the Treatment of Stress Urinary Incontinence and Retention with a Urethral Insertable Valve.

Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of an Oral Iron-Chelating Agent in the Treatment of Thalassemia.

A Randomized, Multicenter, Investigator-Blind Trial Comparing Oral Therapy with a new Antibiotic Drug and Augmentin for the Treatment of Complicated Infections of the Skin and Skin Structure.

A Randomized, Multicenter, Double-Blind, Multicenter Trial Comparing Oral Therapy with a new Antibiotic Drug and Oral Fluxclocacillin for the Treatment of  Uncomplicated Infections of the Skin and Skin Structure.

A Prospective Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Group Sequential-Design, Multi-Center Study to Determine the Safety and Efficacy of Intravenously Administered Experimental Medication in Hospitalized Patients with Severe Traumatic Brain Injury.

A Study of the Patient-Activated Reservoir in the Intrathecal Delivery of Morphine Sulfate as Management of Pain due to Cancer and its Therapies.

A Double-Blind, Placebo-Controlled, Dose-Selection Study of a Controlled Release Muscarinic M3-Receptor Antagonist in Patients with Detrusor Instability or Hyperreflexia and Urge Incontinence.

Evaluation of the Efficacy and Tolerability of a Centrally Acting Agent Monotherapy in Epileptic Patients with Complex Partial Onset Seizures, Having Experienced Improved Seizure Control under Add-On Treatment; a 60-Week, Double-Blind, Multicentre, Responder-Selected Trial.

Multicenter, Placebo-Controlled, Randomized, Double-Blind Study of the Efficacy of an Antidepressive Agent in Hospitalized Patients with Major Depressive Episode Melancholic Type.

A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Osteoporosis Active Medication on the Prevention of Vertrebal Fractures and the Effect on Bone Mineral Density in Women with Postmenopausal Osteoporosis.

A Randomized, Double-Blind, Multinational Phase III Study Comparing the Safety and Efficacy of 2 Neuroleptics in the Treatment of Schizophrenia.

A Multinational, Controlled Phase II Study Comparing the Safety and Efficacy of  Two Different Antibiotics in the Treatment of Acute Community Acquired Pneumococcal Pneumonia.

A Randomized Phase III Study of an Immunosupressive Agent Compared to Placebo on Time to Relapse after Autologous Bone Marrow Transplantation (ABMT) in Patients with Acute Myeloid Leukemia (AML).

A Placebo-Controlled, Parallel-Group, Dose-Ranging Pilot Study of Oral Phentolamine in Patients with Recent-Onset Impotence.

Clinical Study of the Efficacy and Safety of Biosynthetic Human Growth Hormone in Children with Marked Short Stature without Growth Hormone Deficiency.

A Double-Blind, Phase III, Multinational Clinical Study to Evaluate the Safety and Efficacy of a Human Recombinant Cytokine Antagonist in the Treatment of Sepsis Syndrome.

A Randomized, Double-Blind, Phase III, Multinational Clinical Study to Evaluate the Safety and Efficacy of a Dopamine-Agonist Versus Placebo as Adjunctive Early Therapy of Levodopa in Parkinson’s Disease.

A Phase III, Multicenter Single Blind Evaluation of the Efficacy of Low Dose Topical Retinoic Acid in an Optimised Delivery System Compared to Control Formualtions, in Patients with Acne Vulgaris.

Interstitial Chemotherapy for Malignant Glioma:  A Randomized Clinical Trail of the Safety and Effectiveness of a Chemotherapeutic Device Placed at the Time of First Surgery.

Multicenter Evaluation of Safety and Effectiveness of a Urological Nerve Stimulation System for Treatment of Urinary Incontinence or Dysfunctional Voiding Patterns.

Multicenter Evaluation of Safety and Efficacy of a Bladder Stimulation System for Treatment of Neurogenic Bladder Secondary to Spinal Cord Injury with Paraplegia or Quadriplegia.

A Double-Blind, Multicenter Comparison of the Influence of a Combination of a Calcium Channel Blocking Agent and a Hypolipidaemic Agent As Well As of a Calcium Channel Blocking Agent Monotherapy or Respectively, an Hypolipidaemic agent Monotherapy, on Blood Pressure and Lipid Metabolism in Patients with Idiopathic Hypertension and Congenital, Primary Hypercholesterolemia.

Evaluation of the Effects on Growth, Acceptance and Tolerance of a Partially Hydrolyzed Iron-Enriched Cow’s Milk Protein Formula and an Iron Enriched Cow’s Milk Formula Fed to Term Infants from 14 – 120 Days of Life.

A Glucose Study in Insulin Independent (Noninsulin Dependent-Type II) Diabetes Mellitus. A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center Clinical Trial.

Use of an Ointment for Symptoms of Hemorrhoids.