CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 8 target
Drug / intervention
Cyclophosphamide +8 moredrug
Likely dose
Not stated in record
Key inclusion· 13
  • ✓Age 8-24 inclusive at time of consent
  • ✓Diagnosed with Systemic Sclerosis at age ≤19
  • ✓Failed at least 2 DMARDs with disease progression within 12 months
  • ✓Evidence of skin thickening, ILD progression, myositis, arthritis, or digital ulcerations
Key exclusion· 38
  • ✕FVC <35% (Cohort 1)
  • ✕Oxygen saturation <92% at rest on room air (Cohort 1)
  • ✕Estimated CrCl <40 mL/min by Cockcroft-Gault
  • ✕Active, untreated SSc renal crisis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03630211
NCT03630211Phase 2RecruitingOn TrackUpdated 8mo ago
Long Recruiting
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Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc)

Paul Szabolcs·interventional·Posted Aug 14, 2018·Updated Oct 15, 2025

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Mesna, and 7 other interventions for Systemic Sclerosis and 3 related conditions. Currently recruiting, targeting 8 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Sclerosis, Diffuse Sclerosis Systemic, Interstitial Lung Disease, Pulmonary Hypertension
CountriesUnited States
Collaborators--

Timeline

Phase 2Recruiting
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartJul 31, 2018
Primary CompletionAug 1, 2026
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 7.9 years agoPrimary completion in 29 days

Interventions

Cyclophosphamidedrug

Stem Cell Mobilization

Mesnadrug

Stem Cell Mobilization

Rituximabdrug

Transplantation Conditioning

Alemtuzumabdrug

Transplantation Conditioning

Thiotepadrug

Transplantation Conditioning

GM-CSFdrug

Transplantation Conditioning

Intravenous immunoglobulindrug

Transplantation Conditioning

Total Body Irradiationradiation

Transplantation Conditioning

Anti Thymocyte Globulindrug

Transplantation Conditioning