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Allogeneic Mesenchymal Precursor Cells · 1 trial · 1 indication
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...
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Allogeneic Mesenchymal Precursor Cells is an investigational cell therapy being studied for Rheumatoid Arthritis. It is administered as a single intravenous infusion in patients who have had an incomplete response to at least one TNF-alpha inhibitor. The therapy is currently in Phase 2 clinical development.
Allogeneic Mesenchymal Precursor Cells is being developed by Mesoblast Limited, a biopharmaceutical company listed on the stock exchange under the ticker MESO. The company is conducting clinical trials to evaluate this investigational therapy for Rheumatoid Arthritis.
Allogeneic Mesenchymal Precursor Cells is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy in patients with Rheumatoid Arthritis.
Allogeneic Mesenchymal Precursor Cells has been studied in one completed Phase 2 clinical trial, registered as NCT01851070. This was a multi-center, randomized, double-blind, placebo-controlled study involving 48 participants with Rheumatoid Arthritis who had an incomplete response to at least one TNF-alpha inhibitor.
Allogeneic Mesenchymal Precursor Cells is a cell therapy that uses mesenchymal precursor cells, which are a type of adult stem cell with immunomodulatory properties. In Rheumatoid Arthritis, these cells are thought to regulate the immune system and reduce inflammation, although the exact mechanism is still under investigation.