Scleroderma Treatment With Autologous Transplant (STAT) Study
Public ClinicalTrials.gov record NCT01413100. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic Sclerosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase II trial studies how well giving cyclophosphamide and anti-thymocyte globulin together followed by peripheral blood stem cell transplant (PBSCT) and mycophenolate mofetil works in treating patients with systemic scleroderma (SSc). Stem cells are collected from the patient's blood and stored prior to treatment. To store the stem cells patients are given colony-stimulating factors, such as filgrastim (G-CSF) or chemotherapy (cyclophosphamide) to help stem cells move from the bone marrow to the blood so they can be collected and stored. After storage, patients are then given high-dose chemotherapy, cyclophosphamide, and immunosuppression with anti-thymocyte globulin to suppress the immune system to prepare for the transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and immunosuppression. After the stem cells have "engrafted" and have matured enough to support the immune system at approximately 2-3 months, patients are given a medication called mycophenolate mofetil (MMF) or Myfortic. This medication is given to prevent worsening or reactivation of SSc and is referred to as maintenance therapy.
Study identification
- NCT ID
- NCT01413100
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 21 participants
Conditions and interventions
Conditions
Interventions
- Anti-Thymocyte Globulin Biological
- Autologous Hematopoietic Stem Cell Transplantation Procedure
- Cyclophosphamide Drug
- Filgrastim Biological
- Laboratory Biomarker Analysis Other
- Mycophenolate Mofetil Drug
- Peripheral Blood Stem Cell Transplantation Procedure
- Plerixafor Drug
- Quality-of-Life Assessment Other
- Questionnaire Administration Other
Biological · Procedure · Drug + 1 more
Eligibility (public fields only)
- Age range
- Up to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2011
- Primary completion
- Sep 14, 2023
- Completion
- Sep 10, 2024
- Last update posted
- Jan 6, 2025
2011 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 7
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | — |
| University of Colorado | Denver | Colorado | 80217-3364 | — |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center, Houston | Houston | Texas | 77030 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01413100, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 6, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01413100 live on ClinicalTrials.gov.