Jorge M. Mallea, M.D.

Closed for Enrollment

• A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Jacksonville, Fla.

  The purpose of this study is to evaluate the effectiveness and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis.

• A Pilot Study to Evaluate the Safety and Feasibility of Mesenchymal Stem Cells in the Treatment of Subjects with Advanced Chronic Obstructive Pulmonary Disease (COPD) (COPD) Jacksonville, Fla.

  The purpose of this study is to assess the safety and feasibility of mesenchymal stem cells therapy in patients with advanced chronic obstructive pulmonary disease.

• A Prospective, Randomized, Controlled Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Spiration Valve System (SVS) for the Single Lobe Treatment of Severe Emphysema (EMPROVE) Jacksonville, Fla.

  This is a multicenter, prospective, randomized, controlled study designed to evaluate improvement of lung function after treatment with the Spiration Valve System as compared to medical management in the control group. The control group will be evaluated in the same manner as the treatment group.

  The Spiration Valve is a small, umbrella-shaped, one-way valve that is placed inside the airways of one lung. It is used to redirect air from the less healthy to the more healthy parts of the lung. This helps to reduce over-inflation and may improve overall lung function and quality of life for people living with emphysema.

• Pharmacogenetics in Lung Transplant Patients Jacksonville, Fla.

  The purpose of this study is to:

  • Demonstrate pharmacogenetic variability in the Mayo Clinic Florida lung transplant population.
  • Describe patterns in tacrolimus levels in the context of pharmacogenomic profiles
  • Use pharmacogenomic data to establish a need for therapeutic drug monitoring in selected other drugs
  • Use pharmacogenomic data, in combination with knowledge of drug interactions, to establish sensitivity to tacrolimus dose changes
• When Does Oral Intake Change/decline Post Lung Transplant, and is it Modifiable? Jacksonville, Fla.

  The purpose of this study is to monitor patient's oral intake weekly for one month after transplant and to determine the modifiable nutritional risk factors.