Regulation of IL-10 and SLAMF5 in different genetic contexts in Multiple Sclerosis

Date Added
October 10th, 2023
PRO Number
Pro00130192
Researcher
Andrew Keegan

List of Studies

Keywords
Multiple Sclerosis
Summary

The purpose of this study is to better understand how certain parts of the immune system may explain differences seen in the severity of Multiple Sclerosis. This will require one visit, typically less than an hour. We will collect some information about the subject's past medical history including the severity of their multiple sclerosis, and their medications as well as collect a sample of blood. This will also include a measure of genetics related to the immune system. Blood will also be stored for future research.

Institution
MUSC
Recruitment Contact
Alison Line
843-792-2845
line@musc.edu

A multi-site, open-label, Phase II, randomized, controlled Trial to compare the Efficacy of RO7198457 Versus Watchful Waiting in resected, Stage II (high risk) and Stage III Colorectal Cancer patients who are ctDNA positive following resection

Date Added
October 10th, 2023
PRO Number
Pro00129948
Researcher
Toros Dincman

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to learn about the effects of an experimental treatment called RO7198457. This study is for patients with Stage II or III colon or rectal cancer, which has been treated surgically and with chemotherapy, and your blood has been found to have ctDNA (circulating tumor DNA) during a ctDNA screening test. RO7198457 (autogene cevumeran) is an immunotherapy that is individualized to a tumor and designed to mount an immune response against it. Treatment includes RO7198457 being injected in the vein, physical exams, blood sample collections, and CT scans for up to a year. Risks include fatigue, fever, and headache. Patients may or may not receive direct benefit while on the study, however, information collected during this study will help people with colon and rectal cancer in the future. RO7198457 is considered "experimental" because it has not been approved by the U.S. Food & Drug Administration (FDA) for the treatment of any disease.

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

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients with Moderate-to-Severe ARDS: A Phase III Clinical Trial

Date Added
October 19th, 2023
PRO Number
Pro00132554
Researcher
Andrew Goodwin

List of Studies


Keywords
Critical Care
Summary

This study is a multicenter, randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of ExoFlo for the treatment of moderate-to-severe ARDS (Acute Respiratory Distress Syndrome). The purpose of this study is to research and evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles, ExoFlo, as treatment for Moderate-to-Severe ARDS. Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles is an investigational drug created from human bone marrow being studied for the treatment of moderate-to-severe ARDS. This is a research study that will involve monitoring oxygen and inflammation levels after taking the investigational product and assessing the safety of the investigational product. The experimental treatment is a biologic product called Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles Allograft Product ExoFlo, which is purified from the bone marrow of a healthy well-screened individual. Participants will receive either 15mL of the investigational product with 85 mL of normal saline or 100 mL of normal saline only (placebo). The expected duration of participation in the study is a maximum of 61 days, which includes 1-day screening prior to treatment and 60 days following the first treatment.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@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

Alpha-1 Foundation Therapeutic Development Network

Date Added
October 23rd, 2023
PRO Number
Pro00132722
Researcher
Charlie Strange

List of Studies


Keywords
Liver, Lung, Non-interventional, Pulmonary, Rare Diseases
Summary

The Alpha-1 Foundation Therapeutic Development Network (TDN) aims to make it easier to design and carry out clinical trials that enhance the treatment of patients with Alpha-1 Antitrypsin Deficiency (AATD). To achieve this, the TDN will establish a network of clinical trial centers that have enough patients to gather a comprehensive database of clinical and genetic information. This data will be crucial in determining the criteria for including or excluding participants in the trials and in recruiting suitable subjects.

Specifically, this study will enroll participants by in person or remote consent who will allow collection of medical records to be entered into an Alpha-1 TDN database. Participants will then be invited to future clinical trials.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Adults Diagnosed With Epilepsy

Date Added
October 24th, 2023
PRO Number
Pro00131557
Researcher
Jonathan Halford

List of Studies


Keywords
Epilepsy
Summary

The main purpose of this study is to determine if XEN1101 can reduce the seizure frequency and if it is safe to use. Subjects who successfully completed and did not terminate early from one of the antecedent studies (X-TOLE2, X-TOLE3, or X-ACKT) are eligible to participate in X-TOLE4. Following enrollment into X-TOLE4, subjects will undergo a treatment period of up to 3 years, during which there will be a visit at 2-, 4-, and 13-weeks post-entry, with subsequent visits occurring at 13-week intervals during the first year, and then at 26-week intervals (with a telephone call in between) until dosing is completed. All subjects will be initially assigned to receive 25 mg QD of XEN1101. Study drug is to be taken with the evening meal. Subjects will be expected to keep a daily seizure eDiary with a minimum of 80% compliance for the duration of the extension study (reporting on ≥80% of days between visits).
Upon completion of dosing at the end of the treatment period, there will be an 8-week follow-up period.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

Abbott Ventricular Tachycardia Post Approval Study

Date Added
October 24th, 2023
PRO Number
Pro00132390
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular
Summary

This study is enrolling subjects who are scheduled for a ventricular tachycardia (VT) ablation. Ventricular tachycardia is a fast heartbeat that starts with an abnormal signal in the lower chambers of the heart, which are the ventricles. An ablation is a procedure where a catheter (thin, flexible tube) with a tip that can deliver energy is used to burn the heart tissue where those abnormal signals are coming from. The catheter being used in this study is called the FlexAbilityTM Ablation Catheter and was recently approved for commercial use by the Food and Drug Administration. (FDA) Since it is newly approved, the FDA wants to continue collecting more information about the catheter and its use, so this study is called a post approval study. Participation in this study will take about 1 year. During this year, data will be collected including your medical history, cardiac medication use, ablation procedure, and any medical events that may occur. You will be seen or contacted 4 times. There is a risk of loss of confidentiality and there may be risks that are not yet known. There may be no direct benefit to you but it is hoped the information learned may contribute to knowledge in this field.

Institution
MUSC
Recruitment Contact
Chandler Schwede
843-792-5998
schwede@musc.edu

A Phase III, Single-Arm Study to Evaluate the Efficacy and Safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) Administered Intravesically to Patients with BCG-unresponsive Carcinoma in Situ of the Bladder with or without Ta-T1 Papillary Disease

Date Added
October 24th, 2023
PRO Number
Pro00128893
Researcher
Stephen Savage

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Men's Health, Women's Health
Summary

The study is for patients that have been diagnosed with carcinoma in situ of the bladder (localized bladder cancer, also called "non-muscle invasive bladder cancer") with or without Ta-T1 papillary disease (Ta means that the cancer is only in the innermost layer of the bladder lining, T1 means that the cancer has started to grow into the connective tissue beneath the bladder lining). The investigational drug used in this study is ONCOFID-P-B. The main purpose of this study is to understand if the study medicine ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from the standard BCG treatment and are not candidates for radical cystectomy. Participants can expect to be in this study for up to 4 years and will include a screening period of up to 4 weeks followed by up to 33 study visits to the study site.

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

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

Product Surveillance Registry (PSR) Aortic, Peripheral, and Venous (APV) Protocol Synopsis

Date Added
October 24th, 2023
PRO Number
Pro00126447
Researcher
Mathew Wooster

List of Studies


Keywords
Vascular
Summary

The purpose of this registry is to collect safety data in patients undergoing aortic aneurysm repair, peripheral vascular intervention, hemodialysis access intervention or peripheral embolization with an eligible Medtronic market-released product(s), including but not limited to balloon catheters, peripheral or carotid stents, stet grafts, and coils, in a real-world setting.

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



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