Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Diabetes
- Registration Number
- NCT05003908
- Lead 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 Diabetes
- Detailed Description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Diabetes. Patients with Diabetes will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. 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 requiring chemotherapeutic drugs such as methotrexate, an autologous T Cell vaccine will be utilized created from the patient's own T cells obtained by apheresis.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- Diagnosis of Diabetes
- Understanding and willingness to sign a written informed consent document
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group AlloRx Single intravenous infusion of 100 million cells
- Primary Outcome Measures
Name Time Method Safety (adverse events) Four year follow-up Clinical monitoring of possible adverse events or complications
- Secondary Outcome Measures
Name Time Method Efficacy: the level of A1C Four year follow-up A1C blood test will be completed for each follow up point.
Efficacy: the level of C-Peptide Four year follow-up C-Peptide test will be completed for each follow up point.
Efficacy: Insulin dose reduction Four year follow-up Changes of insulin dosage for each follow up point.
Trial Locations
- Locations (2)
Medical Surgical Associates Center
🇦🇬St. John's, Antigua and Barbuda
Center for Investigation in Tissue Engineering and Cellular Therapy
🇦🇷Buenos Aires, Argentina