The trial will be conducted as The purpose of this study is to evaluate the safety and effectiveness of iloprost on the frequency of and relief from symptomatic digital ischemic episodes in subjects with systemic sclerosis.
This is a mechanistic research study to evaluate the relationship between cough, reflux, and aspiration in patients with systemic sclerosis scleroderma. The purpose of this study is to evaluate the safety and tolerability of ixazomib in patients with scleroderma. The purpose of this study is to retrospectively review the charts of patients for whom overnight oximetry data, pulmonary function tests, as well as echocardiographic data have been obtained as part of routine clinical assessment.
In so doing, the hope is to assess the risk of sleep disorder breathing, as evidenced by the oxygen desaturation index ODI on overnight oximetry assessment. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below.
Mayo Clinic is a nonprofit organization and proceeds from Web advertising help support our mission. Mayo Clinic does not endorse any of the third party products and services advertised. The study participation is 14 months. The study will be double-blinded for the first 28 weeks followed by an open-label extension of 24 weeks.
AVID is a new drug that interferes with proteins that are thought to play a major role in the development of fibrosis in scleroderma patients. This trial seeks to assess safety and tolerability of AVID in those with diffuse cutaneous systemic sclerosis dcSSc.
The drug will be administered by intravenous IV infusion once every 2 weeks. Patients will receive a total of 3 infusions, and there will be additional follow-up safety visits for a total of 9 visits over the week study.
All participants will receive AVID This study will utilize intermediate doses of radiation and chemotherapy, paired with intense immunoablative serotherapy, in preparation for an autologous stem cell transplant. Here, CD34 selection will remove potentially autoreactive lymphocytes. The hypothesis is that after T and B-cell depleted autologous graft infusion a normal immune system will reconstitute without regeneration of autoimmunity.
In addition, we propose this conditioning regimen is a safer strategy from a cardiopulmonary, urinary, and bone marrow perspective compared to the published work of other centers, nevertheless, leads to improved SSc symptoms with possible delay of disease recurrence or progression.
Our Physicians and Researchers. Ongoing Clinical Trials. Finding a Cure - Basic Translational Research. Make an Appointment. Systemic Sclerosis Center of Research Translation. Ongoing Research and Clinical Trials.
Currently Enrolling Patients:. Contact Us. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Severe systemic sclerosis SSc is a serious autoimmune disorder in which a person's own immune cells attack organs in the body. SSc affects the skin, joints, lungs, heart, intestinal tract, and kidneys, and half of the patients with the most severe organ involvement die within 5 years. Treatment for SSc usually includes supportive care or immunosuppressive drugs drugs to suppress the immune system.
As the immune cells are believed to be causing the disease, researchers are looking for new therapies that either slow down or stop this process, while not being too toxic. The main purpose of this study is to determine the safety and effectiveness of high-dose immunosuppressive therapy followed by reinfusion transplantation of the participant's own autologous self peripheral blood stem cells PBSCs compared to treatment with monthly for 12 months intravenous doses of cyclophosphamide Cytoxan therapy for the treatment of severe systemic sclerosis SSc.
These treatments are being given in order to determine if they will slow down or stop SSc from becoming more severe, and if they can reverse the effects of the disease. The researchers are evaluating the effects of the two treatments on serious organ damage and survival related to SSc, while also looking at the side effects of the two treatments.
This trial also includes three optional mechanistic sub-studies open to a subset of participants enrolled in the SCOT trial:. They then will receive high doses of chemotherapy and radiation to eliminate their developed and presumably abnormal immune system, followed by autologous stem cell transplantation to reintroduce the purified stem cells to re-establish their immune system.
PubMed ID: citation. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Any active uncontrolled infection that would interfere with high-dose therapy or pulse cyclophosphamide regimens:. Try the modernized ClinicalTrials. Learn more about the modernization effort. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Scleroderma: Cyclophosphamide or Transplantation SCOT The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. Results First Posted : July 14, Last Update Posted : June 2, Study Description. SCOT is a clinical research study designed for people with severe forms of scleroderma. The SCOT study will compare the potential benefits of stem cell transplant and high-dose monthly cyclophosphamide Cytoxan in the treatment of scleroderma.
Detailed Description:. The purpose of this study is to determine the plasma concentration and exposure time required for cyclophosphamide to produce optimal immunosuppressive activity with minimal toxicity in participants with severe systemic sclerosis.
The purpose of this study is to measure and characterize the circulating endothelial progenitor cells from the blood of 30 participants and also to determine the extent of vascular cell apoptosis and proliferation in cutaneous microvasculature in these participants before and after the receipt of the two SCOT treatment regimens. The purpose of this study is [1] to describe the condition of peripheral T cell reactivity and repertoire diversity in SSc patients and evaluate evidence for potential defects prior to randomization, [2] to gain a better understanding of the impact of cyclophosphamide Cytoxan and high-dose immunosuppressive therapy with autologous stem cell transplantation on thymopoiesis, and [3] to describe the kinetics and breadth of T cell immune recovery in SSc patients treated with these interventions.
MedlinePlus related topics: Scleroderma. Drug Information available for: Cyclophosphamide. FDA Resources. Arms and Interventions.
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