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SCOT Clinical Trial (Enrollment Closed)

This study is no longer enrolling patients, as of May 2011

Author: Shelley Ensz. Scleroderma is highly variable. See Types of Scleroderma. Read Disclaimer

"Is autologous hematopoietic stem cell transplantation (HRST)
a superior treatment to high dose I.V. cyclophosphamide?"

SCOT (Scleroderma: Cyclophosphamide Or Transplantation) was 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). (Also see What is Scleroderma?, Types of Scleroderma, Medical Overview, Treatments and Clinical Trials, and Current Clinical Trials)

Study Design
Purpose
Additional Study Details
Screening Phase
Location and Contact Info
Related Articles

Study Design

This study is no longer enrolling patients, as of May 2011

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 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 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, 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. cyclophosphamide.

Additional Study Details

This study is no longer enrolling patients, as of May 2011

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 cyclophosphamide group.

Depending on the group to which you have been assigned, you will either undergo a stem cell transplant or receive high-dose monthly cyclophosphamide.

The active period for the stem cell transplant is approximately 3 months.

The active period for the monthly pulse IV cyclophosphamide 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

This study is no longer enrolling patients, as of May 2011

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 [email protected]

Gastric Antral Vascular Ectasia (GAVE) and Its Clinical Correlates in Patients with Early Diffuse Systemic Sclerosis (Ssc) in the SCOT Trial. GAVE may represent part of the spectrum of the vasculopathy in SSc. Journal of Rheumatology. 02/15/2013. (Also see Gastric Antral Vascular Ectasia (Watermelon Stomach))

This page was posted on this site at the request of Mary Ellen Csuka as a courtesy of the nonprofit International Scleroderma Network. The ISN does not endorse any scleroderma treatment or clinical trial. See disclaimer. Page posted 1-20-10.

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