Clinical Trial

Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases

Recruiting Phase 2
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Summary
A subset of autoimmune diseases (ADs) in children and young adults are life-threatening and unresponsive to conventional treatments. In these patients, the delivery of high dose immunosuppressive therapy followed by autologous stem cell transplant (ASCT) offers a treatment strategy capable of purging the pathogenic, autoreactive immune system and an opportunity for "immune reset." This strategy has been used in adults across a myriad of indications with evidence for efficacy. This study proposes a pilot study to evaluate this therapeutic strategy in children and young adults with systemic sclerosis (SSc) and systemic lupus erythematosis (SLE), two potentially life threatening autoimmune diseases that may response to this therapeutic approach.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-08-29; most recent amendment 2025-10-09.
Trial Details
NCT Number NCT05029336
Lead Sponsor Stephan Grupp MD PhD
Conditions Systemic Lupus Erythematosus, Systemic Sclerosis
Enrollment 20 participants
Start Date 2026-03
Primary Completion 2027-12 (estimated)
Study Completion 2031-05 (estimated)
Updated on ClinicalTrials.gov 2025-10-14