Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01851070 | A Multi-center Study a Single IV Infusion of Allogeneic MPCs in Patients With Rheumatoid Arthritis and Incomplete Response to at Least One TNFα Inhibitor | PHASE2 | COMPLETED | 48 | — | — | Jul 1, 2013 | Mar 1, 2017 | Jun 26, 2020 | 23 | United States, Australia |
To evaluate the safety, tolerability and feasibility of a single intravenous (IV) infusion of allogeneic mesenchymal precursor cells (MPCs) compared to placebo at 12 weeks post-infusion in the treatment of patients with active rheumatoid arthritis (RA) who have received methotrexate +/- other oral DMARDs for at least 4 months and who have had an incomplete response to at least one course of a TNFα inhibitor. Overall safety will be based on the overall assessment of AE/SAEs, Vital Signs, Physical Examination, clinical laboratory tests, ECGs and Chest x-ray.
| Arm | Type | Description |
|---|---|---|
| Normal Saline Placebo | PLACEBO_COMPARATOR | Placebo will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes. |
| Allogeneic Mesenchymal Precursor Cells | ACTIVE_COMPARATOR | Mesenchymal Precursor Cells (MPCs), either 1.0 or 2.0 million cells/kg, will be delivered in 100 mL normal saline administered intravenously over approximately 45 minutes. |
| Name | Type | Description |
|---|---|---|
| Allogeneic Mesenchymal Precursor Cells | DRUG | - |
| Normal Saline | DRUG | - |
Inclusion Criteria: * Males and Females ages 18-80 years old * Active rheumatoid arthritis (RA) disease as per 2010 ACR/EULAR classification criteria for the diagnosis of RA. * Must be positive for rheumatoid factor and/or anti-cyclic citrullinated peptide (anti-CCP3) but without extra-articular di...