Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis

NCT03630211 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-10-15

No results posted yet for this study

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

Interventions

DRUG

Cyclophosphamide

Stem Cell Mobilization

DRUG

Mesna

Stem Cell Mobilization

DRUG

Rituximab

Transplantation Conditioning

DRUG

Alemtuzumab

Transplantation Conditioning

DRUG

Thiotepa

Transplantation Conditioning

DRUG

GM-CSF

Transplantation Conditioning

DRUG

Intravenous immunoglobulin

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630211 on ClinicalTrials.gov