Clinical Research

The Thomas E. Starzl Transplantation Institute has developed a strong infrastructure to support clinical research in abdominal solid organ transplantation.

We have teams of clinical research coordinators and laboratory technicians who manage and support both investigator-initiated and industry studies.

Thomas Hartman, Director of Research Administration & Business Operations, oversees the STI Clinical Research Coordinator Team.

Dr. Diana Metes, directs our Human Immunology Program.

Dr. Camila Macedo Both, directs our STI Sample Biorepository.

David McMichael, manages the STI Clinical Data Warehouse.

Human Immunology

The goal of this collaborative program is to dissect the mechanisms of allograft rejection and acceptance in humans using patient blood and tissue samples. The program takes advantage of the large STI Biorepository and samples collected through Clinical Research.

Human Immunology investigators utilize cutting-edge techniques in cellular immunology, flow cytometry, and single cell multiomics.  Assistance in study design and techniques are available (see Services below).

Ongoing Projects

  1. Diversity fo TFH cells and DSA generation after kidney transplantation
    (NIH RO1, PI: D. Metes)
  2. Regulatory Dendritic Cell (DCreg) Therapy in Live Donor Renal Transplant Recipients
    (NIH UO1, PI: A. Thomson)
  3. Regulatory Dendritic Cell (DCreg) Therapy in Live Donor Liver Transplant Recipients
    (UPMC Immune Transplant and Therapy Center, PI: A. Thomson)
  4. Delayed Regulatory Dendritic Cell (DCreg) Therapy in Live Donor Liver Transplant Recipients
    (UPMC Immune Transplant and Therapy Center, PI: A. Thomson)

Past Projects

  1. Contribution of TFH and TREG cells to generation of DSA in sensitized KTx recipients
    NIH R21 (Metes D)
  2. Regulatory Dendritic Cell (DCreg) Therapy in Live Donor Renal Transplant Recipients
    NIH R34 (Thomson AW)
  3. T and B cell Homeostasis After Induction Therapy in Kidney Transplantation
    NIH RO1 (Lakkis FG)

Investigators

  • Diana Metes, MD – Program Director
  • Angus Thomsom, PhD
  • David Rothstein, MD
  • Camila Macedo, MD
  • Aravind Cherukuri, MD, PhD
  • Heth Turnquist, PhD
  • Paul Szabolcs, MD
  • Sawa Ito, MD, PhD
  • Hossam Abdelsamed, PhD
  • Mark Snyder, MD

Services

The Human Immunology Program provides investigators conducting translational and clinical research scientific and technical expertise in the following areas:

  1. Study design consultation
  2. Assay design and development:
    • Cell co-culture and functional cellular assays
    • Spectral Flow cytometry and cell sorting
    • Bulk and single-cell -omic experiments
    • ELISA and MSD (Meso Scale Discovery) immunoassays
  3. Specimen processing and banking: STI Biorepository
  4. Standard Operating Procedure (SOP) development
  5. Pilot experiments for grant applications
  6. Letters of collaboration
Biorepository Lab Staff

Elaine Lander, Deanna Spaw, Michelle Lucas, Wendy Carricato and Dr. Camila Macedo Both.

STI Sample Biorepository

Since its inception in 2012, over 14000 abdominal organ transplant recipients and donors have been enrolled in the STI Sample Biorepository.

Recipients are asked to provide blood samples:

  • pre-transplant
  • post-transplant: 1m, 3m, 6m, 9m, 12m, and yearly thereafter.
  • At the time of indication biopsies

Urine may also be collected.

Living Donors are asked for a single sample, which can be pre- or post-transplant.

When possible, splenocytes are obtained from deceased donors.

Samples are prepared and stored at -80oC or in liquid nitrogen, as appropriate.

Researchers who are interested in obtaining samples for studies should contact Dr. Macedo Both to discuss feasibility and to learn how to submit a request through Basecamp.

Contact:

Dr. Camila Macedo Both
macecp@upmc.edu
Michelle Lucas
mcmeansmm2@upmc.edu

STI Clinical Research Coordinator Team

The clinical research coordinator team supports studies from the pre-initiation phase to study close-out.  For more information and assistance with clinical research IRB submissions (human subjects), contact Lois Knipling at kniplingle@upmc.edu 

  • Feasibility Assessment – formal or informal
  • Non-disclosure agreements
  • Budget consultation
  • Grant/funding advice
  • Protocol assistance
    • Logistical consultation
  • Preparation of supporting documents
    • Consent forms
    • Manuals – e.g. lab manual, operations manual
    • Components required by NIH – e.g. study timeline, DSMP, recruitment and retention plans
    • Case report forms/Electronic data capture systems
  • Budget preparation in consultation with STI Research Finance
  • IRB Submissions (local or central)
    • Regulatory documents preparation (e.g., financial disclosures, 1572, sponsor-specific forms, etc.)
    • Fiscal forms
    • Subcommittee review documents
  • MTAs
  • IND/IDE preparation and guidance
  • Study start-up
    • Team training
    • Team delegation log
    • RISE audit, if applicable
    • STI Scientific Review or Risk Management Review (as applicable)
    • Clinicaltrials.gov registration preparation for applicable studies
  • Participant recruitment and management
  • Continuing regulatory review submissions
  • Budget monitoring
  • Safety reporting
  • Study close-out

Elaine Lander, Michelle Lucas, Lois Knipling, Rita Johnson, Mary Kruth and Beth Elinoff, Starzl Nurse Coordinators

STI Clinical Research Coordinator Team

  • Beth Elinoff – Nurse Coordinator
  • Rita Johnson– Nurse Coordinator
  • Lois Knipling – Regulatory Coordinator
  • Mary Kruth – Nurse Coordinator
  • Elaine Lander – Nurse Coordinator
  • Michelle Lucas – Biorepository Coordinator

We handle both investigator initiated and industry sponsored trials as well as non-interventional studies.

Highlighted studies:

The Vertex Trial:
Researchers at the University of Pittsburgh Medical Center are working with Vertex Pharmaceuticals to study if an investigational islet cell infusion is safe and effective for providing replacement cells for the ones that have been lost or do not work properly in people with type I diabetes.
The procedure will consist of human stem cell derived pancreas islets called VX-880. These islets are made up of cells that replace those lost as a result of type 1 diabetes.

DCREG Renal study:
After kidney transplant, recipients take drugs called anti-rejection (immunosuppressives) to prevent their body from rejecting the new kidney. At present it is not possible to have a successful transplant without these drugs. Anti-rejection medications must be taken every day, and like other medicines, they may cause side effects. Taking these drugs long term can increase the risk of infections, cancer, or damage to the transplanted kidney. Even with these medications, it is possible for the body to reject the transplanted kidney. Researchers are looking for new ways to prevent rejection and possibly allow transplant recipients to take lower doses of anti-rejection medications over time.

The DCREG renal study is a research study is for people who will be receiving a kidney transplant for the first time and have a living donor. Researchers will be taking white blood cells from the kidney donor by a procedure called leukapheresis. Once they collect these white blood cells, they will select a certain type of white blood cell called monocytes. These monocytes will be used to make cells called, donor-derived regulatory dendritic cells. These donor DCregs will be given through an IV catheter to the recipient one week before transplant. This research study is testing the idea that the donor DCregs might help the body accept the new organ with a lower chance of transplant rejection.

STI Clinical Data Warehouse

The STI Clinical Data Warehouse (CDW) was developed to provide a comprehensive platform for clinical and basic science data.  The CDW unites the clinical and research data thus providing the researcher with a complete picture without having to manage data from separate data sources.  The Clinical Data Warehouse also provides STI with the ability to abstract and store data that otherwise would be difficult to obtain using Natural Language Parsing (NLP).  This enhances the data available from the EMR and provides the researchers with a central place to request and store their data.

For more information or to request data from the STI Clinical Data Warehouse please submit a request through Basecamp or contact David McMichael, mcmichaeld2@upmc.edu