Trial · NCT03630211

Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis

NCT03630211, Phase 2, Recruiting, Paul Szabolcs

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis. Trials, record NCT03630211. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03630211

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis
NCT number: NCT03630211
Status: Recruiting
Phases: Phase 2
Enrollment: 8 participants, estimated
Lead sponsor: Paul Szabolcs
Conditions: Systemic Sclerosis, Diffuse Sclerosis Systemic, Interstitial Lung Disease, Pulmonary Hypertension
Interventions: Cyclophosphamide, Mesna, Rituximab, Alemtuzumab, Thiotepa, GM-CSF, Intravenous immunoglobulin, Total Body Irradiation, Anti Thymocyte Globulin
First posted: 2018-08-14
Last updated: 2026-08-14

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	High Dose Immunoablative therapy-Safety	Up to 36 months post HSCT	Safety will be determined by monitoring for death of any cause, regimen-related toxicities, and severe or life-threatening infections.
Primary	Death	Post Transplant through study completion, an average of 36 months	How many, if any, patients die
Primary	Respiratory Failure	Post Transplant through study completion, an average of 36 months	defined by one of the following 3 criteria without explanation for causation other than disease progression: 1. decline in DLCO of ≥30% or FVC≥20% as measured by actual difference in percent predicted units; 2. Resting arterial p02 \< 60 mmHg or pCO2 \> 50 mmHg supplemental oxygen;3. Resting pulse oximetry of 88% or lower measured by forehead probe.
Primary	Renal Failure	Post Transplant through study completion, an average of 36 months	Defined by chronic dialysis for \>6 months or renal transplantation
Primary	The occurrence of cardiomyopathy	Post Transplant through study completion, an average of 36 months	confirmed by clinical congestive heart failure (New York Heart Association) or LVEF (left ventricular ejection fraction) \<30% on echocardiogram
Primary	Treatment-related mortality (TRM)	Mobilization through study completion, an average of 36 months	defined as death occurring at any time after stem cell mobilization and definitely or probably resulting from treatment given in the study. TRM will be determined yearly with a focus on the first 2 years.
Primary	High Dose Immunoablative therapy-Treatment Effect	up to 36 months post HSCT (hematopoietic stem cell transplantation)	Treatment effect will be determined by assessing event-free survival in comparison to a SSc observational cohort control group treated with standard of care medication (mycophenolate mofetil) at 12 and 36 months post hematopoietic stem cell transplant (HSCT).
Secondary	An increase of mRSS (modified Rodnan skin score ) by ≥5 points for skin score	Disease response will be defined as subject improvement. This will be assessed for both skin and interstitial lung disease at 12 and 24 months post-HSCT.	To assess cutaneous response the modified Rodnan skin score (mRSS) will be used.
Secondary	Increase by ≥25% if the baseline mRSS > 20.	Disease response will be defined as subject improvement. This will be assessed for both skin and interstitial lung disease at 12 and 24 months post-HSCT.	To assess cutaneous response the modified Rodnan skin score (mRSS) will be used.
Secondary	Worsening of > 10% of FVC (pulmonary function testing)	1 year post transplant through study completion, an average of 36 months	to evaluate interstitial lung disease an increase of ≥15% in DLCO or ≥10% of FVC (actual change in % predicted units from baseline) sustained for ≥3 months on 2 determinations.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
42309868	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03630211

GET https://conductscience.org/api/trials/v1/NCT03630211/registered

API reference For AI assistants