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NCT05018858 | RECRUITING | Lupus

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

The Foundation for Orthopaedics and Regenerative Medicine

Brief Summary:

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Lupus

Condition or disease

Lupus

Intervention/treatment

AlloRx

Phase

PHASE1

Detailed Description:

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Lupus. This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Lupus. Patients with Lupus will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy. For patients with more severe disease an autologous T-Cell vaccine will be utilized created from the patient's own cells obtained by apheresis.

Study Type : INTERVENTIONAL
Estimated Enrollment : 15 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Lupus
Actual Study Start Date : 2025-12
Estimated Primary Completion Date : 2028-10
Estimated Study Completion Date : 2028-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Lupus

Location Details

NCT05018858

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Antigua and Barbuda,

Medical Surgical Associates Center

St. John's, Antigua and Barbuda,

RECRUITING

Greece, Athens

Athens Beverly Hills Medical Group

Glyphade, Athens, Greece, 16675