A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination with Belatacept and MPA Compared to Standard of Care Immunosuppression in de novo Renal Transplant Recipients (ASCEND)

Date Added
October 24th, 2023
PRO Number
Pro00128579
Researcher
Prabhakar Baliga

List of Studies


Keywords
Kidney, Transplant
Summary

This is a 12-month, randomized study that involves pre-transplant procedures, a kidney transplant, and post-transplant procedures. After kidney transplantation, every patient, whether in a research study or not, must take immunosuppressive medications to prevent their immune system from rejecting their new kidney. A rejection can harm your new kidney which can lead to lower kidney function. The purpose of this research is to test the safety and effectiveness of siplizumab for kidney transplant patients. Study participants who receive the new study treatment will be compared to participants receiving the most common approved immunosuppressive treatments referred to as "standard of care". You will be randomized into either the study group or the "standard of care" group, like flipping a coin. Because this is a research study, siplizumab will only be given to you during the research study as in infusion treatment. Siplizumab is an investigational medication, which means it has not been approved by the Food and Drug Administration (FDA) and is currently not "on the market" in any country. The potential risks of siplizumab are infusion reactions, inflammatory reactions, immunosuppression, and infections. The benefits of the study treatment are unknown but are suspected to decrease chances of rejection and increase the chance of effective kidney function. An alternative to this study would be to not participate and pursue the standard of care treatment after your kidney transplant.

Institution
MUSC
Recruitment Contact
Kaylie Lively
843-792-1851
lively@musc.edu

Heart Transplant Review

Date Added
October 20th, 2023
PRO Number
Pro00129867
Researcher
Arman Kilic

List of Studies

Keywords
Heart, Transplant
Summary

This study will include all adult (18 years or older) patients who received a heart transplantation at MUSC. This study will conduct a chart review of all adult heart transplant participants to understand how different variables including, donor and recipient comorbidities, donor and recipient medical history, donor and recipient social determinants of health, recipient length of time on transplant waitlist, donor cause of death (morbidity), donor conditions when harvested, recipient presence of mechanical circulatory support (MCS) (temporary or permanent), recipient reason for transplant, recipient use of inotropes and/or vasopressors, recipient pre-transplant lab values, recipient pre-transplant ECHO, recipient pre-transplant right heart catheterization (RHC), donor lab and test values, other donor and recipient imaging studies, recipient surgical time and patient stay data, donor-recipient prediction heart mass (PHM) ratio, recipient medications, donor medications, post-transplant follow-up data, as well as other donor and/or recipient variables, will affect heart transplant outcomes.

Institution
MUSC
Recruitment Contact
Brett Welch
3363174591
welcbret@musc.edu

BEACON: A Phase 1/2 Study Evaluating the Safety and Efficacy of a Single Dose of Autologous CD34+ Base Edited Hematopoietic Stem Cells (BEAM-101) in Patients with Sickle Cell Disease and Severe Vaso-Occlusive Crises

Date Added
June 13th, 2023
PRO Number
Pro00121176
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Transplant
Summary

This is a research study to find out if the study drug called BEAM-101 is safe and effective in the treatment of patients with severe Sickle cell disease (SCD). The study drug, BEAM-101 is a new investigational (experimental) therapy that is the first in human use of this drug.

The study medication uses patients' own stem cells that are harvested through apheresis (process where blood is removed, stem cells collected and blood is returned), changed by genetic modification, and transplanted back into the individual through intravenous infusion to treat severe SCD.

Participation in this study is expected to last approximately 24 months, starting at time of screening, through the collection of cells, transplantation of study drug, and 15-month follow-up period. Study visits during the screen and mobilization period will vary depending on the cell collection process, in other words, the mobilization and collection period could be 3 separate visits to harvest adequate stem cells. Subjects are then hospitalized for the conditioning period, transplantation of study drug and engraftment period (when blood counts return to normal). The follow up visits after discharge from the hospital will be monthly for the first 6 months, then every other month until 24 months post transplant period.

At the end of the 24 months, all participants will be asked to enroll in the long-term extension study for a duration of 13 years making the total follow-up period of 15 years.

Institution
MUSC
Recruitment Contact
Brandi Day
843-792.3379
dayb@musc.edu

Multifaceted Intervention To Improve Graft outcome disparities in African American Kidney Transplants

Date Added
April 18th, 2023
PRO Number
Pro00127666
Researcher
David Taber

List of Studies


Keywords
Transplant
Summary

This is a randomized study to test a smartphone app that a pharmacist will use to help kidney transplant patients track their medications, blood pressures, and blood sugars if they have diabetes. The goal of this study is to improve care and outcomes in kidney transplant patients and, in particular, help African American patients have better outcomes after transplant.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

Date Added
January 24th, 2023
PRO Number
Pro00125967
Researcher
David Taber

List of Studies


Keywords
Drug Studies, Transplant
Summary

The purpose of this study is to find out if there is a difference in how well the standard MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in preventing CMV infections in kidney transplant recipients who are at risk for this type of infection, while also assessing the tolerability of these two regimens. The two medication regimens being compared are valganciclovir (FDA approved to prevent and treat CMV infection) vs maribavir (FDA approved to treat CMV infection) plus acyclovir (FDA approved to prevent HSV infection).

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies.

Date Added
August 16th, 2022
PRO Number
Pro00118834
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Pediatrics, Transplant
Summary

This study is for patients that have had hematopoietic stem cell transplants and/or have been donors. The purpose of this study is to see how well transplant works in adults with a MMUD using stem cells from a donor's blood, and in children with a MMUD using stem cells from a donor's bone marrow.This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for transplant. Participants can expect to be on this study for approximately 1 year.

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

A trial of transplanting Hepatitis C-viremic kidneys into Hepatitis C-Negative kidney recipients (THINKER-NEXT)

Date Added
July 3rd, 2022
PRO Number
Pro00119881
Researcher
John McGillicuddy

List of Studies

Keywords
Infectious Diseases, Kidney, Transplant
Summary

This research study is being done to determine whether it is safe to give a kidney transplant from a donor with hepatitis C to a patient without hepatitis C. This study is looking for participants in need of a kidney transplant who are willing to accept a kidney from a patient with hepatitis C.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

A Phase 1/2 Study to Evaluate the Safety and Efficacy of a Single Dose of Autologous Clustered Regularly Interspaced Short Palindromic Repeats Gene-edited CD34+ Human Hematopoietic Stem and Progenitor Cells (EDIT-301) in Subjects with Severe Sickle Cell Disease

Date Added
February 8th, 2022
PRO Number
Pro00106939
Researcher
Jennifer Jaroscak

List of Studies


Keywords
Transplant
Summary

This is a research study to find out if a study drug called EDIT-301 is safe and effective in treatment of patients with severe Sickle Cell Disease (SCD). The EDIT-301 study medicine is a new investigational therapy, which in this case means this is first-in-human use of this study drug. This study medication uses patients' own stem cells, modifies the cells with genetic modification, and transplants them back to the patient (by infusion) to treat SCD.
Participation in this study is expected to last approximately 30 months, including time for screening, collection of cells, transplant, and a 24 month follow-up period after transplant. At the end of that 24 month follow-up, the participant will be asked to participate in an additional long-term follow-up study, totaling 15 years of post-transplant follow-up.

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

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu

Molecular Assessment and Profiling of Liver transplant rEcipients: The MAPLE Study

Date Added
December 23rd, 2021
PRO Number
Pro00115748
Researcher
Jared White

List of Studies


Keywords
Liver, Transplant
Summary

The primary purpose of this registry is to evaluate the feasibility and clinical validation of LiverCare in liver transplant recipients, as part of post-transplant surveillance. LiverCare is an investigational panel test that includes 6 components: 1. AlloSure Liver 2. AlloMap Liver 3. AlloHeme Liver 4. iBox Liver 5. HistoMap Liver 6. AlloID. AlloSure Liver is a research test used to measure donor-derived cell free DNA in Liver transplant recipients. AlloMap Liver is a research gene expression profile test using peripheral blood to establish immune activity and is currently undergoing clinical evaluation and development. iBox Liver is an analytic platform that predicts organ outcomes after transplant using a software algorithm based on information from your medical records and is currently undergoing clinical evaluation and development. AlloHeme Liver is a diagnostic test to measure donor and recipient DNA in the blood. HistoMap Liver is a tissue-based gene expression test using tissue collected from standard of care biopsies to establish immune profiles within the organ and is currently undergoing clinical evaluation and development. AlloID is a blood test that will quantify the presence of more than 100 pathogens including standard post-transplant infectious disease screening such as Cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus, Human Herpesvirus 6 (HHV-6) and viral hepatitis.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Deanna DeHoff
843-792-8522
dehoff@musc.edu



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