Rheumatoid Arthritis
Conditions
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 Rheumatoid Arthritis
Detailed description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Rheumatoid Arthritis (RA). Patients with RA 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
Interventions
BIOLOGICALAlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Sponsors
The Foundation for Orthopaedics and Regenerative Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Rheumatoid Arthritis * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse events) | Four year follow-up | Clinical monitoring of possible adverse events or complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: the 28-joint disease activity score (DAS 28) | Four year follow-up | DAS 28 is used to determine the disease activity for RA. It will be completed for each follow up point. |
| Efficacy: visual analog scale (VAS) | Four year follow-up | VAS is a scale that is used to measure pain. It will be completed for each follow up point. |
Countries
Antigua and Barbuda, Argentina
Outcome results
None listed