Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Lupus

Launched by THE FOUNDATION FOR ORTHOPAEDICS AND REGENERATIVE MEDICINE · Aug 20, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new treatment for lupus, a chronic autoimmune disease. Researchers will be giving participants an intravenous infusion of mesenchymal stem cells, which are special cells derived from umbilical cord tissue. The goal is to see if this treatment can help manage lupus symptoms without causing significant side effects.

To be eligible for this trial, participants must have a confirmed diagnosis of lupus and be willing to sign a consent form to participate. However, individuals with active infections, cancer, or serious organ failure, as well as pregnant women or those with certain medical conditions, will not be able to take part. The trial is currently recruiting participants of all genders and ages. Those who join can expect to be monitored closely for their safety during the treatment process. This study is an early-phase trial, meaning it’s one of the first steps in understanding how this treatment might work for lupus patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of Lupus
• • Understanding and willingness to sign a written informed consent document
• Exclusion Criteria:
• • Active infection
• • Active cancer
• • Chronic multisystem organ failure
• • Pregnancy
• • Clinically significant Abnormalities on pre-treatment laboratory evaluation
• • Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
• • Continued drug abuse
• • Pre-menopausal women not using contraception
• • Previous organ transplant
• • Hypersensitivity to sulfur