Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis
NCT03630211 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2025-10-15
Summary
The purpose of this study is to determine whether a regimen of high-dose immunoablative therapy will demonstrate safety that is consistent or improved with other published regimens in SSc patients, while maintaining a treatment effect.
Conditions
- Systemic Sclerosis
- Diffuse Sclerosis Systemic
- Interstitial Lung Disease
- Pulmonary Hypertension
Interventions
- DRUG
-
Stem Cell Mobilization
- DRUG
-
Mesna
Stem Cell Mobilization
- DRUG
-
Transplantation Conditioning
- DRUG
-
Alemtuzumab
Transplantation Conditioning
- DRUG
-
Thiotepa
Transplantation Conditioning
- DRUG
-
Transplantation Conditioning
- DRUG
-
Transplantation Conditioning
- RADIATION
-
Total Body Irradiation
Transplantation Conditioning
- DRUG
-
Anti Thymocyte Globulin
Transplantation Conditioning
Sponsors & Collaborators
-
Paul Szabolcs
lead OTHER
Principal Investigators
-
Paul Szabolcs, MD · University of Pittsburgh
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-31
- Primary Completion
- 2026-08-01
- Completion
- 2026-08-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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