Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases

Launched by STEPHAN GRUPP MD PHD · Aug 29, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for children and young adults with serious autoimmune diseases, specifically systemic lupus erythematosus (SLE) and systemic sclerosis (SSc). These conditions can be life-threatening and may not respond well to standard treatments. The study is investigating whether a combination of high-dose immunosuppressive therapy followed by an autologous stem cell transplant (ASCT) — where a patient's own stem cells are used — can help reset the immune system and improve health outcomes.

Eligible participants for this trial are children and young adults between the ages of 8 and 25 who have severe forms of SLE or SSc and are in good overall health without active infections. Those who have had previous stem cell transplants, are pregnant, or are involved in other clinical trials may not qualify. If chosen to participate, individuals can expect to receive a personalized treatment plan and close monitoring throughout the process. This study offers a potential new hope for those facing these challenging autoimmune diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 8 ≤ 25 years at time of enrollment.
• • 2. Severe systemic sclerosis or systemic lupus erythematosus based on specific criteria
• • 3. Adequate organ function status
• • 4. No active, untreated infections.
• Exclusion Criteria:
• • 1. Previous hematopoietic stem cell transplant (HSCT) or solid organ transplant
• • 2. Pregnancy
• • 3. Ongoing participation in a clinical trial testing an investigational drug or ongoing receipt of disallowed disease modifying anti-rheumatic drugs (DMARD)
• • 4. Severe comorbidity that jeopardizes the ability of the subject to tolerate therapy