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Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis

Study acronym: SSc
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Aug 1, 2026 → Aug 1, 2028
See other at-risk trials from Paul Szabolcs

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Aug 1, 2026 to Aug 1, 2028v15
  2. Primary completion date: Aug 1, 2025 to Aug 1, 2026v14
  3. Site contacts updated at 1 of 3 sitesv13
  4. Primary completion date: Aug 1, 2024 to Aug 1, 2025
    • Study completion date: Aug 1, 2025 to Aug 1, 2026
    v12
  5. Primary completion date: Aug 1, 2023 to Aug 1, 2024v11
Show 9 earlier versionsHide 9 earlier versions
  1. Re-verified, no change to tracked fieldsv10
  2. Eligibility criteria shortened, about 181 words
    • Site contacts updated at 1 of 3 sites
    • Study description shortened, about 2 words
    v9
  3. Interventions: Alemtuzumab (Drug), Cyclophosphamide (Drug), GM-CSF (Drug), Intravenous immunoglobulin (Drug), Mesna (Drug), Rituximab (Drug), Thiotepa… to Alemtuzumab (Drug), Anti Thymocyte Globulin (Drug), Cyclophosphamide (Drug), GM-CSF (Drug), Intravenous immunoglobulin (Drug), Mesna…
    • Eligibility criteria expanded, about 762 words
    • Study description shortened, about 127 words
    • Site contacts updated at 1 of 3 sites
    v8
  4. Re-verified, no change to tracked fieldsv7
  5. Site contacts updated at 1 of 3 sitesv6
  6. Re-verified, no change to tracked fieldsv5
  7. Interventions: Alemtuzumab (Drug), Cyclophosphamide (Drug), GM-CSF (Drug), Mesna (Drug), Rituximab (Drug), Thiotepa (Drug) to Alemtuzumab (Drug), Cyclophosphamide (Drug), GM-CSF (Drug), Intravenous immunoglobulin (Drug), Mesna (Drug), Rituximab (Drug), Thiotepa…
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (6)
    • Site contacts updated at 1 of 3 sites
    v4
  8. Eligibility criteria revisedv3
  9. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Aug 2018 to Jul 31, 2018
    • Secondary endpoints revised (6)
    • Study description expanded, about 8 words
    • Site details revised at 3 of 3 sites
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Paul Szabolcs
9 trials monitored
See 2 trials at risk
Hypertension
1,925 trials monitored
See 99 trials at risk
Scleroderma
324 trials monitored
See 13 trials at risk
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.
Trial Details
NCT Number NCT03630211
Lead Sponsor Paul Szabolcs
Conditions
(from sponsor)		 Systemic Sclerosis, Diffuse Sclerosis Systemic, Interstitial Lung Disease, Pulmonary Hypertension
Related terms Hypertension, Pulmonary, Lung Diseases, Interstitial, Scleroderma, Diffuse, Scleroderma, Systemic
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov