Scleroderma Clinical Trials (MAIN MENU)
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Current Trials, Open Enrollment
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Scleroderma Clinical Trials: Current Studies, Open Enrollments
Overview
AIMSPRO
Allogenic Stem Cell Transplant
ASTIS Study

Bosentan, Tracleer
Cyclophosphamide, Cytoxan
Cyclophosphamide and rATG With Hematopoietic Stem Cell Support
Imatinib mesylate (Gleevec)
Pulmonary Fibrosis with SSc

SCOT Trial (Cytoxan vs. SCT)
Sildenafil Citrate (Viagra)
Stem Cell Transplants
Twins and Siblings Study
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)
Associated Conditions
Brain
Dental/Mouth
Eyes
Fatigue
Gastrointestinal
Heart (Cardiac)
Kidney (Renal)
Liver
Lung (Pulmonary)
Photos of Symptoms
Pregnancy
Raynaud's
Similar Skin Diseases
Sjogren's Syndrome
Skeletal (Bones, Joints Muscles)
Skin and Hair
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
Open Enrollments
Stem Cell Transplantation Centers
Research Studies
Transplant Funding
Media Stories
Patient Stories
ASTIS Study
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.
Overview of Bosentan
Bosentan for Digital Ulcers
Bosentan for Heart Involvement in SSc
Bosentan for Pulmonary Fibrosis
Bosentan for Pulmonary Hypertension
Bosentan for Raynaud's
Bosentan for Skin Fibrosis
Media Stories about Bosentan
Also See
Cyclophosphamide (Cytoxan ®) and Revimmune
Current Studies, Initial Results Positive
Cyclophosphamide (Cytoxan) and Revimmune for Scleroderma Lung Disease. Clinical trial and research information on cyclophosphamide for pulmonary alveolitis. 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.
Journal Publications by Richard K. Burt, M.D. Division of Immunotherapy. Northwestern University, Chicago, Illinois.
Imatinib Mesylate (Gleevec)
Current Studies, Open Enrollment, Initial Results Positive, 2008
Imatinib Mesylate (Gleevec) Clinical Trials for Systemic Scleroderma. Imatinib mesylate (Gleevec) is currently used for certain forms of leukemia, and is now in the following clinical trials for safety and efficacy for systemic scleroderma. ISN.
Pulmonary Fibrosis with Systemic Sclerosis
Open Enrollment, 2008
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.
High Dose Cyclophosphamide (CYC) Without Stem Cell Transplantation in Systemic Sclerosis. High dose CYC without stem cell transplantation leads to rapid improvement of the modified Rodnan skin, HAQ, and PGA scores in the severe early diffuse SSc. Christopher V. Tehlirian. 689 ACR 2006. (Also see: Cytoxan, ASTIS Clinical Trial, and Skin Fibrosis)
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)
(Also see: Pulmonary Hypertension)
Stem Cell Transplants for Scleroderma
Continuing Studies, Open Entrollment
Stem Cell Transplants (Bone Marrow Transplants) for Early Diffuse Scleroderma. ISN.
Open Enrollments
Stem Cell Transplantation Centers
Research Studies
Transplant Funding
Media Stories
Patient Stories
Twins and Siblings With and Without Autoimmune Diseases
Open Enrollment (A 5-year study)

NIH Autoimmune Twins and Siblings StudyFamilies with Twins or Siblings where one has Systemic Rheumatic Disorders (Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Lupus, Scleroderma, or Myositis) and one does not. The goal of study 03-E-0099 is to assess why one twin or sibling developed disease and why the other brother or sister did not.

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)

See Also
Sjögren's Treatments & Clinical Trials
Scleroderma Medical News
Scleroderma Symptoms (treatments are listed for each symptom)
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Go to Stem Cell (Bone Marrow) Transfusion
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