A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of CC-220 In Subjects With Active Systemic Lupus Erythematosus Save

Date Added
November 14th, 2017
PRO Number
Pro00069388
Researcher
Gary Gilkeson

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Keywords
Lupus
Summary

The purpose of this study is to see if a new drug called CC-220 can be safe and effective to treat patients with Systemic Lupus Erythematosus. CC-220 is an oral medication. The study will last for about one year and will involve 16 study visits. There are two parts to the trial: In the first, patients will be assigned to get either CC-220 at 0.45mg, 0.3mg, 0.15 mg, or placebo (no active study drug). In the second part, all patients who got placebo during the first part will be re-assigned to get CC-220 at either 0.45mg or 0.3mg. The study will be blinded, which means you will not know which medication you are getting during either of the two parts. You will see a Rheumatologist, and give a blood and urine sample at each visit. The data obtained from this study will provide additional information to further assess the benefit and risk profile of CC-220 for the treatment of lupus.

Institution
MUSC
Recruitment Contact
Daniel Melcher
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A Phase I Safety Trial of Allogeneic Mesenchymal Stem Cells for Systemic Lupus Erythematosus Save

Date Added
December 20th, 2016
PRO Number
Pro00061632
Researcher
Gary Gilkeson

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Keywords
Autoimmune disease, Lupus
Summary

The purpose of this study is to evaluate the safety of mesenchymal stem cells (MSCs) obtained from an umbilical cord for the treatment of adults with systemic lupus erythematosus (SLE). The primary goal is to determine if a single MSC infusion is safe and well-tolerated for patients with mild to moderately active SLE.

Institution
MUSC
Recruitment Contact
Angela Robinson
843-792-6043
robia@musc.edu

A Phase II Controlled Trial of Allogeneic Mesenchymal Stem Cells for the Treatment of Refractory Lupus Save

Date Added
June 16th, 2015
PRO Number
Pro00039894
Researcher
Gary Gilkeson

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Keywords
Autoimmune disease, Lupus
Summary

The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC infusion plus standard of care respond better than patients receiving a placebo infusion plus standard of care.

Institution
MUSC
Recruitment Contact
Angela Robinson
843-792-6043
robia@musc.edu

Mesenchymal Stem Cells (MSC) obtained from Healthy Donor Umbilical Cords Save

Date Added
November 18th, 2014
PRO Number
Pro00037760
Researcher
Gary Gilkeson

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Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to obtain viable mesenchymal stem cells (MSCs) from umbilical cords in uncomplicated pregnancies. Potential donors will be screened prior to donation of umbilical cords to confirm no prevalent autoimmune disease or other viruses and/or diseases. The overall goal is to obtain MSCs from healthy donors for eventual transfusion into patients for the treatment of autoimmune disease, specifically systemic lupus erythematosus.

Institution
MUSC
Recruitment Contact
Angela Robinson
843-792-6043
robia@musc.edu

Sex Differences in Gut Permeability: Impact on Autoimmunity Save

Date Added
September 16th, 2014
PRO Number
Pro00037761
Researcher
Gary Gilkeson

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Keywords
Healthy Volunteer Studies
Summary

The Department of Rheumatology is looking for adult volunteers to participate in a research study at the Medical University of South Caroline to help us investigate
the gender differences in immune responses to
bacteria in the stomach and intestines.

Participants will be asked to complete one to three 30 minute visits, answer questions about their medical history, and provide a blood sample at each visit.

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
modzik@musc.edu

A 5-Year Prospective Observational Registry to Assess Adverse Events of Interest and Effectiveness in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Treated with or without BENLYSTA™ (belimumab) Save

Date Added
March 25th, 2014
PRO Number
Pro00031972
Researcher
Gary Gilkeson

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Keywords
Autoimmune disease, Lupus
Summary

This study is designed to evaluate the incidence of adverse events of special interest (AESI), as well as certain effectiveness measures over 5 years in adults with active autoantibody-positive SLE who are treated with or without BenLysta.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-4095
baczko@musc.edu

The Multidisciplinary Clinical Research Center for Rheumatic Diseases in African Americans Save

Date Added
January 15th, 2013
PRO Number
Pro00021985
Researcher
Gary Gilkeson

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Keywords
Autoimmune disease, Environmental Factors, Ethnicity and Disease, Genetics, Healthy Volunteer Studies, Lupus, Minorities, Rare Diseases, Scleroderma
Summary

Systemic lupus erythematosus (lupus; SLE) and Systemic Sclerosis (scleroderma; SSc) are relatively rare rheumatic diseases that disproportionately impact the African American community, and particularly African American women. The causes of lupus and scleroderma are unknown, but thought to include both genetic and environmental factors. We are enrolling lupus and scleroderma patients, and healthy control subjects. This is not a drug study. The purpose of this study is to better understand the factors that predispose people to develop lupus and scleroderma. Information about medical, social and family history, medications, physical exam findings, and laboratory tests will be collected for analysis. This study will involve approximately 910 volunteers.

Institution
MUSC
Recruitment Contact
Stephanie Slan
843-792-8997
slans@musc.edu

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