A PHASE I, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SUBCUTANEOUS ADMINISTRATION OF UMBILICAL CORD DERIVED - MESENCHYMAL STROMAL CELL THERAPY IN ADDITION TO STANDARD OF CARE AS A TREATMENT FOR ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS

Date Added
August 27th, 2024
PRO Number
Pro00136482
Researcher
Kathleen Maksimowicz-McKinnon

List of Studies

Keywords
Autoimmune disease, Drug Studies, Lupus
Summary

The goal of this study is to determine if an investigational product (a substance not approved by the US Food and Drug Administration) made from mesenchymal stromal cells (MSC) and taken as a single subcutaneous injection, is safe and well tolerated in individuals with active lupus while also receiving standard of care treatment for their lupus.

The MSCs used in this trial are cells that were obtained from the umbilical cords of healthy donors having an elective Caesarean section and who have been screened to be sure that they are free of any infectious diseases.

Participation in the study will take about 13 visits and 2 telephone calls over a period of approximately 80 weeks or 1.5 years. With participation, compensation is available.

At study visits you will have blood and urine labs collected, physical exam/lupus specific assessments, and be asked to complete a questionnaire. These procedures are much like those completed at your routine standard of care visits with your rheumatologist.

The risks to study participation are that only a few hundred people worldwide have been treated with MSCs. So far, there have been no serious side effects when MSCs have been used. Potential risks could however include an allergic reaction to the cells, development of infection, or MSCs changing into cancer cells.

Prior to any use of the MSC injection, participants will have a thorough review of the study and given an opportunity to consider their options and have all questions/concerns answered. A screening visit will be completed to ensure that participation is appropriate - participant safety is a priority of the study.

Institution
MUSC
Recruitment Contact
Stephanie Dezzutti
843-792-8997
brays@musc.edu

A Randomized Phase 3 Trial of Continuous vs. Intermittent Maintenance Therapy with Zanubrutinib as Upfront Treatment in Older Patients with Mantle Cell Lymphoma (INTERCON)

Date Added
August 26th, 2024
PRO Number
Pro00136417
Researcher
Katherine Antel

List of Studies

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

This study is for subjects that have been diagnosed with mantle cell lymphoma. The purpose of this study is to compare continuous treatment with zanubrutinib to treatment with zanubrutinib that is stopped after the initial six 28-day cycles of chemotherapy and restarted at the first time your disease gets worse following the initial six 28-day cycles of chemotherapy. The subject may remain in the study for up to 10 years.

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

Situation Awareness incorporating Multidisciplinary Teams Reduce Arrests In the Pediatric ICU in the Pediatric Resuscitation Quality Collaborative

Date Added
August 21st, 2024
PRO Number
Pro00136396
Researcher
Allison Whalen

List of Studies


Keywords
Pediatrics
Summary

Each day in the United States, approximately 41 children experience in-hospital cardiac arrest (IHCA) requiring cardiopulmonary resuscitation (CPR). A lack of situation awareness was cited as the most common contributing factor to serious safety events within children's hospitals. Situation awareness is the ability to monitor what is happening, integrate information to develop a comprehensive picture, and extrapolate forward to project the future. The primary objective of this study is to implement unit based interventions (SAMURAI PICU bundle) to reduce the incidence of IHCA in pediatric intensive care units using quality improvement methodology.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@musc.edu

A Novel Harm Reduction Approach for Oncology Outpatients who Smoke and Refuse Traditional Tobacco Treatment

Date Added
August 20th, 2024
PRO Number
Pro00138162
Researcher
Alana Rojewski

List of Studies


Keywords
Cancer, Smoking
Summary

For patients in cancer care, quitting smoking is critical, but a significant portion of patients in cancer care refuse all components of tobacco treatment, even when offered proactively and free of charge. The proposed clinical trial will assess one harm reduction intervention, switching completely from cigarettes to e-cigarettes, among oncology outpatients who smoke and refuse traditional tobacco treatment.

Institution
MUSC
Recruitment Contact
Rachel Bracci
843-737-1516
chrisrac@musc.edu

A Phase 3, Multicenter, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging of Men with Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy with Pelvic Lymph Node Dissection (Pathfinder)

Date Added
August 16th, 2024
PRO Number
Pro00135932
Researcher
Robert Grubb

List of Studies


Keywords
Bladder, Cancer, Cancer/Genitourinary
Summary

The purpose of this research study is to see how effective the use of copper Cu 64 PSMA I&T Injection is in imaging prostate cancer tumors for staging of men with newly diagnosed intermediate or high risk prostate cancer who are planned to have radical prostatectomy with pelvic lymph node dissection. Three hundred twenty-three (323) patients are planned for enrollment in this Phase 3 study, at approximately 60 sites in the U.S. and Europe. Copper Cu 64 PSMA I&T Injection is an investigational imaging agent, given to you via IV injection, that may make tumors from prostate cancer show up better during a nuclear medicine imaging scan. The imaging scan is a type of nuclear medicine imaging test, which means it uses a radioactive drug and a special camera to create pictures of your tumor(s). Copper Cu 64 PSMA I&T Injection is investigational in the United States which means that the U.S. Food and Drug Administration (FDA) has not yet approved it.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

A First-in-Human, Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose-Optimization, and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of PARP1 Selective Inhibitor, IMP1734, in Patients with Advanced Solid Tumors

Date Added
August 14th, 2024
PRO Number
Pro00136726
Researcher
Brian Orr

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to test IMP1734 in humans for the first time and to assess the safety, tolerability, PK, PD, and anti-tumor activity of IMP1734 in patients with advanced solid tumors. The study will be conducted in 3 parts. Part 1 (dose escalation): Dose-escalation phase where the MTD (or MAD) will be
determined and safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMP1734. Part 2 (dose optimization): Further evaluation of the safety, tolerability, PK, PD, and preliminary anti-tumor activity of selected dose levels of IMP1734. Part 3 (dose expansion): Efficacy, safety, and PK of IMP1734 with the dose(s) selected based on accumulated data will be assessed in either patients who have not received prior therapy with a PARPi containing treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

The Global Paradise® System US Post Approval Study (US GPS)

Date Added
August 13th, 2024
PRO Number
Pro00138696
Researcher
Thomas Todoran

List of Studies


Keywords
Hypertension/ High Blood Pressure
Summary

This study will enroll two groups of participants. The first group are those who participated in the RADIANCE CAP study, so have already undergone the renal denervation procedure. Those participants can enroll in this post approval study which will entail yearly follow up visits or telephone calls, blood pressure monitoring and questionnaires. The second group of participants are those scheduled to undergo a procedure called renal denervation for the treatment of high blood pressure that has not responded adequately to medications and lifestyle changes. Renal denervation is a procedure which uses a catheter (thin hollow tube) placed in the renal arteries (blood vessels that go to the kidneys) to deliver ultrasound energy. This energy will heat up a small area of tissue around the renal arteries to disable nerves that are surrounding the blood vessels as a way to help reduce blood pressure. Study visits include screening, procedure, discharge, months 1, 3, 6 and 12 then yearly for up to 5 years. Study procedures for this group includes blood work and urine studies, blood pressure monitoring, questionnaires, a follow up ultrasound of your kidneys and the blood vessels around the kidneys. Study related risks include loss of confidentiality, blood draw risks and unknown risks.

Institution
MUSC
Recruitment Contact
Anthony Awkar
843-876-5009
awkar@musc.edu

Health Outcomes of Parents with Cystic Fibrosis (HOPe:CF) Aim 2

Date Added
August 13th, 2024
PRO Number
Pro00136818
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis
Summary

We will follow 146 new parents of children <5 years of age at 18 participating US
adult CF centers to assess the primary outcome of ppFEV1 up to 5 years after
becoming a parent. A prospective approach will capture the immediate and longterm impact of the use of the highly effective CFTR modulator ETI by ~90% of US
adults with CF. By combining objective health measures and participant surveys,
we can comprehensively assess the psychosocial impacts of parenthood and
explore the interplay between the parenting role and physical and mental health.
We anticipate identifying modifiable factors that may ameliorate negative health
impacts of parenthood.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

Date Added
August 9th, 2024
PRO Number
Pro00133370
Researcher
Brian Hess

List of Studies


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

This study is for subjects that have been diagnosed with Follicular Lymphoma.
This study is testing an investigational drug(s) called Epcoritamab that is not approved by the FDA (Food and Drug Administration). The purpose of this study is to see if the combination of the study drug epcoritamab with rituximab and lenalidomide has a better response rate than standard of care chemoimmunotherapy in the treatment of follicular lymphoma. The total study treatment duration is up to 2.5 years. You may stop the study treatment early if you do not respond after 6 months, your disease worsens, you no longer tolerate the study drug(s), or you withdraw from the study.

Once you finish the study treatment or discontinued study treatment early, you will continue to the Post-Study Treatment Follow Up Period, you will come back to the study clinic every 6 months for the first 3 years and then yearly to have imaging scans and blood work to check if your disease is in remission or worsen.

If your disease worsens or if you start a new FL treatment, you will enter the Long-term Follow Up Period, you will be called by telephone or your health record will be reviewed to check on your well-being and to see what your next treatment plan will be. This follow-up may last up to 15 years.

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

A Phase II Study of Naxitamab Added to Induction Therapy for Subjects With Newly Diagnosed High-Risk Neuroblastoma

Date Added
August 8th, 2024
PRO Number
Pro00134887
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Drug Studies, Men's Health, Pediatrics, Women's Health
Summary

This study is for patient that have been diagnosed with High Risk Neuroblastoma. The investigational drug in this study is naxitamab. The purpose of this study is to test the safety of adding an Anti-GD2 Immunotherapy agent (naxitamab) to your standard therapy during the induction phase of care. Read the sections on risks and benefits carefully and be sure you understand them. This study will also look at the effectiveness of this treatment.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinicaltrials@musc.edu



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