| Scleroderma Clinical Trials (MAIN MENU) | |
|
| SCOT Clinical Trial |
"Is autologous hematopoietic stem cell transplantation (HRST) a superior treatment to high dose I.V. cyclophosphamide?" |
| SCOT (Scleroderma: Cyclophosphamide Or Transplantation) is being sponsored by the National Institutes of Health (NIH) through its Division of Allergy, Immunology and Transplantation (DAIT) in the National Institute of Allergy and Infectious Diseases (NIAID). |
This study is currently recruiting patients. |
|
| Study Design |
| The SCOT study is a pivotal, prospective, randomized, clinical research study for individuals with diffuse systemic sclerosis (SSc). Subjects between the ages of 18 and 69 years (inclusive) will be enrolled across North America and randomly assigned in a 1:1 ratio to one of two groups: high-dose monthly Cytoxan (cyclophosphamide) or autologous stem cell transplantation. |
| " The study is unique because in addition to evaluating a treatment, the study has several mechanistic studies to help better understand the pathophysiology of scleroderma." Mary Ellen Csuka. |
| SCOT Trial. The SCOT study will compare the potential benefits of stem cell transplant and high-dose monthly cyclophosphamide (Cytoxan) in the treatment of scleroderma. These 2 approaches are investigational which means that they are still being tested in research studies and are not approved by the U.S. Food and Drug Administration (FDA) for the treatment of scleroderma. SCOT Study. (Also see: Cyclophosphamide, Cytoxan and Stem Cell Transfusion) |
| The stem cells used in the SCOT trials are autologous hematopoietic stem cells, adult blood stem stem cells that come from each participant's own body. The SCOT study does not involve embryonic stem cells (stem cells from embryos). |
| Purpose |
| The primary objective is to evaluate differences in the rates of death and significant organ damage between the two groups: stem cell transplant or I.V. Cytoxan (cyclophosphamide). . |
| Additional Study Details |
| For Interested Participants. Participating in the SCOT study may provide you with access to an investigational approach for treating your scleroderma that you may not otherwise be able to receive. |
| The SCOT study involves a screening phase to make sure you are eligible for the study. After the screening phase, if you are eligible and decide to participate, you will enter the study-procedure phase where you will be randomly assigned to the stem cell transplant or high-dose monthly Cytoxan group. |
| Depending on the group to which you have been assigned, you will either undergo a stem cell transplant or receive high-dose monthly Cytoxan. |
| The active period for the stem cell transplant is approximately 3 months. |
| The active period for the monthly pulse IV cyclophosphamide (Cytoxan) is approximately 12 months. |
| At 6, 12, 24, 36, 42, 48, and 60 months after enrollment, all study participants will have a thorough evaluation to check out the function of the heart, lungs, and gastrointestinal system and the response to the study procedure. In addition, all participants will undergo frequent physical examinations and laboratory tests over the first year. After the first year, follow-up visits will occur at least every year through year 5. |
| Screening Phase |
| Screening Phase.
The screening process may last up to 2 months and is designed to check the extent of your disease condition and determine if you are eligible for the study. You will have a variety of tests performed to find out how scleroderma has affected your internal organs. These tests are outlined in the consent form. SCOT Trials. |
| Location and Contact Information |
| There are currently over 25 transplant and rheumatology centers throughout the United States participating in the SCOT trials. To find one near you, check out the SCOT Study Sites. |
| If you have additional questions about participating in the SCOT study, please contact us at 1-866-909-SCOT or contact@sclerodermatrial.org. |
| Related Articles |
| Autologous hematopoietic stem cell transplant (AHSCT) in systemic sclerosis: quantitative high resolution computed tomography of the chest scoring. The extent of SSc lung involvement on high resolution computed tomography (HRCT) rapidly but transiently regressed after AHSCT. Launay D. (PubMed) J Rheumatol. 2009 Jul;36(7):1460-3. |
| TV Video: Hannah - Health Insurance Story. View her fight for insurance coverage for the SCOT Trial, with David Becker, ISN Assistant News Guide. Posted 11-16-09. (Also see: Patient Rights, and David Becker) |
| 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, and Skin Fibrosis) |
| This page was posted on this site at the request of Mary Ellen Csuka as a courtesy of the nonprofit International Scleroderma Network. At our option, we offer to make and post free web pages for any scleroderma group in the world. The ISN does not endorse any scleroderma treatment or clinical trial. See disclaimer. Page posted 1-20-10. |
Get our free Sclero e-Newsletter!
