Basic Research and Clinical Trials

Research in the Miami Transplant Institute includes basic laboratory and clinical research within our three main divisions: Kidney and Pancreas, Liver and Gastrointestinal and Heart and Lungs transplant.

The overall mission of our research is to study novel immunosuppressive treatments in order for our transplanted patients to attain a better quality of live after transplantation: reducing the side effects of medications, as well as reducing the incidence of transplant rejection after cadaveric or living-related donor transplants.

Our research is organized in two main groups: Basic laboratory and Clinical Trials research.

Basic research is organized at the Heart and Lungs transplant program under the direction of Dr. Si Pham as well as at the Liver and GI transplant program under the direction of Dr. Andreas Tzakis.

Clinical trials are organized within the other two groups under the direction of Dr. George Burke for the Kidney and Pancreas Program and Dr. Andreas Tzakis for the Liver and GI program.

Our research is funded under different sources; institutional, government/agency and Industry.

BASIC RESEARCH
Our current research includes the following projects:

Effects of Aging and Bone Marrow Stem Cells on Neointimal Formation
Sponsor: American Heart Association
Sponsor Group: Agency
P.I: Si Pham, M.D.
Cellular Therapeutics and Mechanisms of Vascular Dysfunction in Heart and Kidney Disease. Project leader of Project #3: Mechanisms Responsible for Exacerbated Neointimal Formation by Nicotine
Sponsor: Florida Department of Health
Sponsor Group: Agency
P.I: Si Pham, M.D.
The Role of Nicotine in Smoking-Related Vascular Diseases
Sponsor: Florida Department of Health
Sponsor Group: Agency
P.I: Roberto Vazquez-Padron, Ph.D.
The Effect of PIF (Pre-Implantation Factor) in Heterotopic Heart Transplant in Mice
Sponsor: Institution
Sponsor Group: Institutional
P.I: Andreas Tzakis, M.D.
In Vivo Assessment of Intraportal T regulatory Cell Infusion in a Mouse Model.
Sponsor: Institution
Sponsor Group: Institutional
P.I: Andreas Tzakis, M.D.

CLINICAL RESEARCH
Our Clinical Research is divided into the following areas:

Heart and Lung Transplant

Kidney and Pancreas Transplant

Assessment of Allograft Recipient Bone Marrow and Blood Cell Chimerism, Immune Reactivity and Regulatory Properties Following Transplantation and Bone Marrow Infusion.
Protocol: 19950548
Sponsor: Institution
P.I.: George Burke, M.D
Assessment of Simultaneous Pancreas/Kidney (SPK) Allografts Recipient Bone Marrow, Skin, and Blood Cell Chimerism, Immune Reactivity and Regulatory Properties Following Transplantation With of Without Donor Bone Marrow Infusion
Protocol: 19960130
Sponsor: Institution
P.I.: George Burke, M.D
Tacrolimus and Mycophenolate Mofetil vs Tacrolimus and Sirolimus in SPK, Pancreas after Kidney or Pancreas Transplant Alone.
Protocol: 20000176
Sponsor: Institution
P.I.: George Burke, M.D
Pilot Study Using Donor Stem Cells and Campath-1H to Induce Renal Transplant Tolerance
Protocol: Subcontract 3270 - N01-A1-15416 / 20030235
Sponsor: Immune Tolerance Network (NIH)
Sponsor Group: Government
P.I.: George Burke, M.D.
Recurrence of T1D in Pancreas Transplantation
Protocol: 5R01DK070011-04 / 20050510
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIH)
Sponsor Group: Government
P.I.: George Burke, M.D.
Solid Organ Transplant in HIV: Multi-Site Study
Protocol: 20051311
Sponsor: University of California San Francisco (NIH)
Sponsor Group: Government
P.I.: Jorge Diego, M.D.
A Phase II, Open-Label, Multicenter Study to Assess the Pharmacokinetics, Long-Term Safety and Tolerability of Tacrolimus in Stable Kidney Transplant Patients Converted from a Prograf Based Immunosuppression Regimen to a Modified Release (MR) Tacrolimus Based Immunosuppression Regimen
Protocol: 20020507
Sponsor: Astellas Pharma US, Inc.
Sponsor Group: Industry
P.I.: George Burke, M.D.
Randomized Trial of 2 Antibody Induction Steroid Avoidance Protocols Accompanied by Maintenance Therapy with Prograf and Myfortic
Protocol: 20060047
Sponsor: Novartis Pharmaceutical Corporation
Sponsor Group: Industry
P.I.: George Burke, M.D.
A Randomized, Placebo Controlled, Double-Blind Comparative Study Evaluating the Effect of Ramipril on Urinary Protein Excretion in Maintenance Renal Transplant Patients Converted to Sirolimus
Protocol: 20070779
Sponsor: Wyeth Pharmaceuticals
Sponsor Group: Industry
P.I.: George Burke, M.D.
Evaluation of Recipients with and without Proteinuria, Pre and Post Kidney
Transplantation - FSGS
Protocol: 20070206
Sponsor: Institutional
P.I.: George Burke, M.D

Liver and Gastrointestinal Transplant

A Phase II Multicenter Trial to Assess the Safety and Efficacy of Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation
Protocol: 3676SC N01-AI-15416 / 20043108
Sponsor: Immune Tolerance Network (NIAID)
Sponsor Group: Government
P.I.: Andreas Tzakis, M.D.
A Retrospective Review of Patients and Graft Survival for Liver Transplant Recipients using Campath-1H as Induction Therapy
Protocol: 20043395
Sponsor: Institutional
P.I.: Andreas Tzakis, M.D.
A Pilot Study of Pharmacokinetics of Myfortic (Mycophenolic Acid) in Liver and Intestinal Transplant Recipients
Protocol: 20043153
Sponsor: Novartis Pharmaceuticals Corporation
Sponsor Group: Industry
P.I.: Andreas Tzakis, M.D.
Functional Outcomes in Pediatric Liver Transplantation
Protocol: R01 HD045694 - CMH Agreement - 20053200
Sponsor: Children's Memorial Hospital (NICHHD)
Sponsor Group: Government
P.I.: Andreas Tzakis, M.D.
Randomized Evaluation of Fibrosis Due to Hepatitis C after de Novo Liver Transplant
Protocol: 20057419
Sponsor: Novartis Pharmaceutical Corporation
Sponsor Group: Industry
P.I.: Andreas Tzakis, M.D.
A Humanitarian Device Exemption Use Protocol of TheraSphere® For Treatment of Unresectable Hepatocellular Carcinoma
Protocol: 20057624
Sponsor: Nordion
Sponsor Group: Industry
P.I.: Andreas Tzakis, M.D.
Prospective Study to Evaluate the Utility of Serum Citrulline Concentration and Citrulline from Dried Blood Spots Simultaneously for the Detection of Acute Cellular Rejection in Small Bowel Transplantation.
Protocol: 20043158
Sponsor: NIH
Sponsor Group: Government
P.I.: Andreas Tzakis, M.D.
SPLIT, Studies of Pediatric Liver Transplantation, is a multi-center, prospective study to collect scientific data in pediatric liver transplantation
Protocol: 19980264
Sponsor: NIH
Sponsor Group: Government
P.I.: Andreas Tzakis, M.D.
Solid Organ Transplant in HIV: Multi-Site Study
Protocol: 20057647
Sponsor: University of California San Francisco (NIH)
Sponsor Group: government
P.I.: Andreas Tzakis, M.D.
A Prospective, Open-Label, Multi-Center, Randomized Trial of the Efficacy and Safety of a Long Term Calcineurin Inhibitor Free Maintenance Regimen with Mycophenolate Mofetil and Sirolimus in Recipients of an Orthotopic Liver Transplant
Protocol: 20050274
Sponsor: Roche Laboratories, Inc.
Sponsor Group: Industry
P.I.: Andreas Tzakis, M.D.
A Clinical Trial to Collect Long Term Follow-Up Data for Orthotopic Liver Transplantation Subjects Previously Enrolled in the Nabi-4204 Study
Protocol: 20070887
Sponsor: Biotest Pharmaceuticals Corporation
Sponsor Group: Industry
P.I.: Jang Moon, M.D.
A Phase II, Open-Label, Multi-Center Prospective, Conversion Study in Stable Liver Transplant Patients to Compare the Pharmacokinetics of LCP-Tacro Tablets Once-A-Day to Prograf Capsules Twice-a-Day
Protocol: 20071052
Sponsor: LifeCycle Pharma A/S
Sponsor Group: Industry
P.I.: Andreas Tzakis, M.D.
Evaluation of Belatacept as First-Line Immunosuppression in de Novo Liver Transplant Recipients
Protocol: 20071111
Sponsor: Bristol-Myers Squibb Co
Sponsor Group: Industry
P.I.: Andreas Tzakis, M.D.
A Multicenter, Open-Label, Randomized, Phase 1B Study Evaluating the Safety and Tolerability of Intravenous Recombinant Human Mannose-Bindin Lectin (rhMBL) in Liver Transplant Recipients
Protocol: 20071195
Sponsor: Enzon Pharmaceuticals Inc.
Sponsor Group: Industry
P.I.: Andreas Tzakis, M.D.
Identification and Mechanistic Investigations of Tolerant Transplant Recipients
Protocol: 20071031
Sponsor: Institution
Sponsor Group: Institutional
P.I.: Andreas Tzakis, M.D.
An analysis of factors associated with acute rejection in patients that have received an isolate or composite intestinal graft.
Protocol: 20070275
Sponsor: Institution
Sponsor Group: Institutional
P.I.: Andreas Tzakis, M.D.
A study to investigate the immunological profile of liver and intestinal transplant recipients
Protocol: 20071079
Sponsor: Institution
Sponsor Group: Institutional
P.I.: Andreas Tzakis, M.D.
Retrospective study of effect of liver transplant on portal hypertension and hypersplenism
Protocol: 20070545
Sponsor: Institution
Sponsor Group: Institutional
P.I.: Andreas Tzakis, M.D.
A study to investigate the immunological profile of liver and intestinal transplant recipients
Protocol: 20071079
Sponsor: Institution
Sponsor Group: Institutional
P.I.: Andreas Tzakis, M.D.
Retrospective study of effect of liver transplant on portal hypertension and hypersplenism
Protocol: 20070545
Sponsor: Institution
Sponsor Group: Institutional
P.I.: Seigo Nishida, M.D.
A study to investigate the immunological profile of liver and intestinal transplant recipients
Protocol: 20071079
Sponsor: Institution
Sponsor Group: Institutional
P.I.: Andreas Tzakis, M.D.
Mobilization of Stem Cells with G-CSF in Patients With End Stage Liver Disease
Protocol: 20080091
Sponsor: Institution
Sponsor Group: Institutional
P.I.: Andreas Tzakis, M.D.
A Retrospective Outcomes Analysis of Cytomegalovirus (CMV) Hyperimmune Gammaglobulin (CytoGam) Use in Liver and Small Bowel Transplant Recipients from 2002-2005 at the University of Miami
Protocol: 20080229
Sponsor: CSL Behring
Sponsor Group: Industry
P.I.: Andreas Tzakis, M.D.
A screening study for markers of tolerance for liver transplant patients that have received Campath-1H induction immunosuppression at the time of the transplant.
Protocol: 20080378
Sponsor: Immune Tolerance Network
Sponsor Group: Government
P.I.: Andreas Tzakis, M.D.