Actively Recruiting

Phase 2
Age: 8Years - 25Years
All Genders
NCT05029336

Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases

Led by Stephan Grupp MD PhD · Updated on 2025-10-14

20

Participants Needed

1

Research Sites

269 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases

Who Can Participate

Age: 8Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 8 to 25 years at time of enrollment
  • Diagnosis of severe systemic sclerosis or systemic lupus erythematosus based on specific criteria
  • Adequate organ function status
  • No active, untreated infections
Not Eligible

You will not qualify if you...

  • Previous hematopoietic stem cell transplant or solid organ transplant
  • Pregnancy
  • Ongoing participation in a clinical trial testing an investigational drug or ongoing receipt of disallowed disease modifying anti-rheumatic drugs (DMARD)
  • Severe comorbidity that jeopardizes the ability of the subject to tolerate therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

P

Patricia M Hankins

CONTACT

C

Caitlin Elgarten, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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