Long-term Follow-up of Subjects With Sickle Cell Disease Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector

Date Added
October 15th, 2020
PRO Number
Pro00096640
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Transplant
Summary

This is a multi-center, longterm safety and efficacy follow-up study for
subjects who have been treated with the LentiGlobin BB305 drug product
on HGB-206 sickle cell gene therapy parent study. This study is
observational only, and no investigational treatment will be given on this
follow-up study. Participants for this study are requested to follow-up
every six months for the first three years and then once every year for the
remaining Year 4 through Year 13, totaling thirteen years in this longterm
study. Study assessments will include exams, laboratory studies,
imaging, ECG, surveys, and record review.

Institution
MUSC
Recruitment Contact
Brandi Day
843-792-3379
dayb@musc.edu

TruGraf® Long-term Clinical Outcomes Study

Date Added
September 11th, 2020
PRO Number
Pro00102741
Researcher
Vinaya Rao

List of Studies


Keywords
Transplant
Summary

This study will enroll kidney transplant patients to evaluate the TruGraf and TRAC blood tests which can help monitor for transplant kidney rejection. Participants will have blood draws every 3 months for 2 years and the study team will collect information on long term health outcomes.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

Cell mediated immunity in COVID19 infection

Date Added
August 13th, 2020
PRO Number
Pro00101915
Researcher
Satish Nadig

List of Studies


Keywords
Infectious Diseases, Transplant
Summary

This study will examine immunity to COVID-19 infection in healthy individuals, healthy transplant patients, and patients diagnosed with COVID-19. Blood samples will be collected from participants over a period of 3 years that will be tested for immunity.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@musc.edu

A 12-month, open-label, multicenter, randomized, safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) study of two regimens of anti-CD40 monoclonal antibody, CFZ533 vs. standard of care control, in adult de novo liver transplant recipients with a 12-month additional follow-up (CONTRAIL I)

Date Added
February 25th, 2020
PRO Number
Pro00089195
Researcher
Derek DuBay

List of Studies


Keywords
Liver, Transplant
Summary

This study is testing an investigational (not yet FDA approved) drug called CFZ533 compared to standard of care anti-rejection medications in patients who are having a Liver transplant. This study drug is being tested because it may have fewer long-term side effects than current standard therapy. This study is for first time liver transplant patients. Study drug will be administered every 2 weeks and participation will last for 2 years after transplant surgery.

Institution
MUSC
Recruitment Contact
Tamara Jenkins
843-792-1851
saundert@musc.edu

Reducing Disparities in Living Donation Among African Americans

Date Added
January 2nd, 2020
PRO Number
Pro00092908
Researcher
Derek DuBay

List of Studies


Keywords
Diabetes, Hypertension/ High Blood Pressure, Kidney, Transplant
Summary

Kidney donation from a living donor provides the kidney recipient with the best chance of a longterm survival of the transplanted kidney. White End Stage Renal Disease (ESRD) patients are 4 times more likely to recieve a living donor kidney than are African American (AA) ESRD patients. There are many reasons for this disparity in obtaining the benefits of living donation for AAs, including lack of knowledge regarding the living donation process. This study will provide a web-based educational intervention to overcome this knowledge deficiency with the hope that there will be an increase in patient interest in living donation which will result in more living donation kidney transplant inquiries by patients' family or friends.

Institution
MUSC
Recruitment Contact
Thomas Morinelli
843-792-5405
morinelt@musc.edu

EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR)

Date Added
December 18th, 2019
PRO Number
Pro00093140
Researcher
Vinaya Rao

List of Studies


Keywords
Transplant
Summary

This study will monitor for kidney rejection using the Allosure and AlloMap test. Subjects will be followed for 3 years post transplant.

Institution
MUSC
Recruitment Contact
Kandace Taylor
843-792-7082
taylokan@musc.edu

Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Cyclophosphamide-based Conditioning for Allogeneic Hematopoietic Stem Cell Transplant

Date Added
November 5th, 2019
PRO Number
Pro00091874
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Transplant
Summary

This study is for subjects that are about to receive high dose cyclophosphamide before a blood or bone marrow transplant (BMT). The investigational drug in this study is Olanzapine. This research is being done to find out whether adding olanzapine to standard medications will be helpful in controlling chemotherapy induced nausea in children. The total length of participation in this study will depend on how many days you are scheduled to receive chemotherapy, but can be up to a maximum of 2 weeks. We will review your chart for 100 days after transplant. There will be no extra visits to MUSC due to participating in the research study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation

Date Added
August 7th, 2019
PRO Number
Pro00089654
Researcher
Amarendra Neppalli

List of Studies


Keywords
Cancer, Transplant
Summary

This study is for participants that require an allogenic peripheral blood stem cell transplant. The purpose of this study is to compare 2 combinations of drugs to prevent graft-versus-host disease (GVHD), a serious complication of a stem cell transplant. These combinations are either Tacrolimus/methotrexate or Tacrolimus/mycophenolate mofetil/cyclophosphamide. Doctors want to know which combination is better or if they give the same results. The study will help doctors decide which treatment is best at preventing GVHD for future transplant patients. Participants can expect to be in this study for up to 2 years after transplant.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES) PBMTC SUP1701

Date Added
May 7th, 2019
PRO Number
Pro00084735
Researcher
Michelle Hudspeth

List of Studies


Keywords
Cancer, Pediatrics, Transplant
Summary

This study is for patients that have had a Hematopoietic Stem Cell Transplant (HSCT) and still have persistent Cytomegalovirus (CMV), adenovirus and/or Epstein-Barr Virus (EBV) infection; or have a Primary Immunodeficiency Disorder (PID) with one or more viral infections that persist. The primary purpose of the study is to evaluate whether most closely HLA-matched multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell lines (VSTs) have antiviral activity against three viruses: EBV, CMV and adenovirus. Participants can expect to be on this study for about 12 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

The effect of conversion to once-daily Envarsus on the neurologic toxicity burden in liver transplant recipients

Date Added
April 9th, 2019
PRO Number
Pro00083855
Researcher
Derek DuBay

List of Studies


Keywords
Liver, Transplant
Summary

The aim of this study is to determine if a long-acting tacrolimus product can reduce the severity and incidence of several neurotoxicities commonly seen after liver transplant. The medications being used in this study are extended release tacrolimus (Envarsus) and immediate release tacrolimus (Prograf). Participants will receive SOC treatment for up to 15 days and no longer than 12 months post-transplant, and then randomized to either Envarsus or Prograf for the 6 month duration of the study. There are 9 study visits that will involve tests, exams and procedures that are both standard of care and study purposes.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-7082
rowle@musc.edu



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