Actively Recruiting
Safety Study of Intravenous Adult Umbilical Cord Derived Stem Cell Infusion for Lupus Treatment
Led by The Foundation for Orthopaedics and Regenerative Medicine · Updated on 2025-04-08
15
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This trial investigates the safety and effectiveness of an intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells UC-MSCs for treating Lupus. The study is patient-funded and focuses on evaluating this biological treatment in individuals diagnosed with Lupus. For those with more severe disease, an additional autologous T-Cell vaccine made from the patients own cells will be used. Participants will receive a single intravenous infusion containing a total dose of 100 million UC-MSCs. The treatment group is referred to as AlloRx. Patients with severe cases may also receive the T-Cell vaccine created through apheresis. This is a phase 1 interventional study without blinding or placebo control. Participants will be evaluated before treatment and then followed up at 1, 6, 12, 24, 36, and 48 months after infusion to monitor safety and efficacy. Researchers will specifically track safety by recording any adverse events over a four-year follow-up period. The total study duration for each participant spans up to four years from the initial treatment.
CONDITIONS
Brief Title
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Lupus
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