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Overview of Scleroderma Clinical Trials and Treatments
Systemic Scleroderma Symptoms. At present, there are no proven treatments or cure for any forms of scleroderma. However, there are effective therapies for many of the symptoms as well as clinical trials for specific scleroderma related symptoms. ISN. (Also see: What is Scleroderma and Types of Scleroderma)
Treatment of complications associated with systemic sclerosis. Systemic sclerosis is characterized by various circulatory, dermatological, gastrointestinal, musculoskeletal, pulmonary, and renal complications. Although there is no cure for systemic sclerosis, management of its associated complications can help improve patients' quality of life. (PubMed) Am J Health Syst Pharm. 2008 Feb 15; 65(4):315-21.
AIMSPRO for Systemic Sclerosis
AIMSPRO in Established Diffuse Cutaneous Systemic Sclerosis. To study the safety and tolerability of a hyperimmune goat serum product (AIMSPRO) in the treatment of systemic sclerosis (SSc) through a period of 26 weeks of study participation. The secondary objective of the study is to assess the efficacy of AIMSPRO as a therapeutic agent for SSc using inter alia the SSc-HAQ questionnaire and the modified Rodnan skin score. ClinicalTrials.gov.
Sypharma - Press Release. Australia’s Sypharma, a privately owned company will be supplying an aseptically manufactured biological (AIMSPRO) for clinical trials in Europe. AIMSPRO is an injectable hyperimmune caprine serum derivative. Two clinical trials with AIMSPRO address late stage Scleroderma (Diffuse Sclerosis) and Bladder Dysfunction in Secondary Progressive Multiple Sclerosis. BioInternational Corporation. 6/11/08.
Allogeneic Hematopoietic Stem Cell Transplantation (NST) for Patients With Systemic Sclerosis
ASTIS Study: High Dose Immunoablation and Hematopoietic Stem cell Transplantation versus Monthly Intravenous Pulse Therapy Cyclophosphomide in Severe Systemic Sclerosis. ISN.
Bosentan, Tracleer
Bosentan (Tracleer) appears to be beneficial for a variety of scleroderma symptoms, such as digital ulcers, pulmonary fibrosis, pulmonary hypertension, and skin fibrosis. ISN.
Cyclophosphamide and rATG with Hematopoietic Stem Cell Support
Cyclophosphamide and rATG With Hematopoietic Stem Cell Support Clinical Trial. To evaluate the efficacy (phase II) of two treatment modalities: pulse cyclophosphamide versus high dose cyclophosphamide and rATG (rabbit antithymocyte globulins) rescued with autologous peripheral blood stem cell transplant (PBSCT). Currently recruiting. Northwestern University. ClinicalTrials.gov. Contact information: d-spahovic@northwestern.edu and tel 1-312-908-0059.
Recruiting is taking place for a multi-center placebo controlled research study for pulmonary fibrosis with systemic sclerosis sponsored by Novartis Pharmaceuticals. Male and female patients, 18 to 65 years of age may be eligible for participation.
Interested patients can contact the Medical College of Wisconsin (414-456-7019), University of Houston (713-500-7118), UCLA (310-825-4744), Boston University (617-638-4344) or at John Hopkins University (410-550-8582) in Baltimore, Maryland. Novartis Pharmaceuticals. Posted 01-04-08. (Also see: Pulmonary Fibrosis and What is Scleroderma?)
SCOT Trial
Open Enrollment, 2005-2008
SCOT Clinical Trial, which stands for "Scleroderma Cyclophosphamide Or Transplantation", will compare two potential therapies: autologous stem cell transplantation versus high-dose monthly cyclophosphamide. Study dates 2005-2008. (Also see: Cyclophosphamide, Cytoxan and Stem Cell Transfusion)
Scleroderma Patient Experiences: SCOT Trial on You Tube. A short film documenting the experiences of several patients undergoing experimental treatment for scleroderma. It also includes physician interviews which provide information on the SCOT study and advances in research. Duke Clinical Research, 11-17-08.
Sildenafil Citrate (Viagra) for Pulmonary Hypertension
Continuing Studies, Positive Results
Surface Logix Commences Phase 2a Clinical Trial of SLx-2101 in Raynaud's Disease. SLx-2101 is a novel, long-acting PDE-5 inhibitor being developed for the management of diseases associated with vascular dysfunction such as Raynaud's. The company has also completed four Phase 2a clinical studies in hypertension, Raynaud's disease and erectile dysfunction, all of which further demonstrated the efficacy of the compound. Surface Logix Inc. 2008. (Also see: Raynaud's Treatments)
The siblings may or may not be twins, but must be of the same gender and be within a 3-year age difference. Biological parents, or, in some cases, children, will also be included in the study.
Families may enroll at the NIH Clinical Center in Bethesda, Maryland, just 9 miles north of Washington, DC or at their local physician’s office. Transportation assistance may be available and there is no charge for study-related evaluations and medical tests.
For information on the study, call the NIH patient recruiting office toll free at 1-800-411-1222 (For TTY: 1-866-411-1010). National Institutes of Health Clinical Center (NIH). 11/25/05. (Also see: Scleroderma Research Registries and Causes of Scleroderma: Genetics)
Families with Twins or Siblings where one has Systemic Rheumatic Disorders (Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Lupus, Scleroderma, or Myositis) and one does not.