Infusion of stem cells from umbilical cords for treating Lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients diagnosed with Lupus. Participants will receive a single infusion of 100 million UC-MSCs and will be monitored for safety and efficacy at various intervals over a period of up to four years. The study aims to provide insights into the potential benefits of stem cell therapy for Lupus, particularly for those with more severe disease who may also receive an autologous T-Cell vaccine. The trial is patient-funded and seeks to contribute to the understanding of stem cell treatments in autoimmune conditions.

Why it matters

Who can join: the full rules

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

Where it's running

• Prodromos Stem Cell Institute
  Naples, Florida, United States Recruiting
• Prodromos Stem Cell Institute
  Athens, Greece Recruiting

Study contacts

• Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.