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Also known as Rexlemestrocel-L
Allogeneic Mesenchymal Precursor Cells · 4 trials · 3 indications
Low back pain intensity will be measured using a VAS ranging from 0-100 millimeter (mm). A score of 0 represents no pain and 100 represents worst possible pain.
Overall treatment success was determined based on number of responders who had composite response at both months 12 and 24 evaluated per specified criteria. A treatment responder with treatment success was defined as a participant who met the 3 criteria of a composite responder analysis as: 50% or greater reduction in the lower-back pain visual analogue scale (VAS) score; 15-point or greater reduction in the Oswestry Disability Index (ODI) score; and lack of post-treatment interventions at the treated level as of the study visit (Visits 6 \[12 months post-treatment\] and 8 \[24 months post-treatment\]). The average response rate (proportion of participants with response presented as Bayesian estimate\[BE\]) was based upon the average of multiple Bayesian simulations.
Non-fatal decompensated heart failure (HF) event was adjudicated when the diagnosis of a nonfatal decompensated HF event demonstrated the presence of signs and symptoms consistent with clinical decompensation of the participant's HF state requiring an in-hospital stay or intravenous (IV) diuretic therapy or aquapheresis during an urgent care outpatient HF visit. TCEs were defined as a composite of cardiac death, left ventricular assist device (LVAD) placement, heart transplant, or artificial heart implantation. Adjudication of all potential non-fatal HF-MACE or TCEs was performed by an independent, blinded Clinical Endpoints Adjudication Committee (CEC) based on the cardiac adjudication manual. Negative number in the time to event range indicates that event occurred to the subject before treatment.
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 |
|---|---|---|
| Rexlemestrocel-L + HA | EXPERIMENTAL | Participants will receive rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with hyaluronic acid (HA) solution on Day 0. |
| Control Group | SHAM_COMPARATOR | Participants will receive saline solution as a sham procedure to simulate the active treatment injection on Day 0. |
| Rexlemestrocel-L | EXPERIMENTAL | Participants received rexlemestrocel-L 2.0 mL injection of approximately 6 million rexlemestrocel-L cells in freeze media mixed in a 1:1 by-volume ratio with saline on Day 0 (Visit 2). |
| Placebo | PLACEBO_COMPARATOR | Participants received saline solution as matching-placebo on Day 0 (Visit 2). |
| Sham Control | SHAM_COMPARATOR | Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results. |
| 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 |
|---|---|---|
| Rexlemestrocel-L + HA mixture | DRUG | Rexlemestrocel-L will be combined in 1:1 by-volume ratio with HA solution and the resulting mixture will be administered as intradiscal injection. |
| Saline | DRUG | Saline solution injection adjacent to the index disc. |
| Rexlemestrocel-L | DRUG | Rexlemestrocel-L injection |
| Placebo | DRUG | Saline control solution |
| Sham Comparator | OTHER | The sham procedure was staged to script and did not include actual cardiac mapping or delivery of rexlemestrocel-L. |
| Allogeneic Mesenchymal Precursor Cells | DRUG | - |
| Normal Saline | DRUG | - |
Inclusion Criteria: * Participants with moderate to severe low back pain for a duration of at least six months who have failed at least 3 months of conservative care. * Participants who have moderate radiographic degeneration of an intervertebral disc from L1 to S1, with a single disc suspected of ...
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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.