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Also known as Allogeneic Mesenchymal Precursor Cells
Rexlemestrocel-L · 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 ...
Top 2 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Mesoblast Limited Sponsored ADR | MESO | 1 | PHASE3 | Rexlemestrocel-L |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
Rexlemestrocel-L is an investigational allogeneic cell therapy developed by Mesoblast Limited (ticker MESO). It is being studied in chronic heart failure and degenerative disc disease, including chronic low back pain. It is also known as Rexlemestrocel-L + HA mixture, reflecting a formulation combined with hyaluronic acid. It holds an FDA RMAT designation and is in late-stage development.
Rexlemestrocel-L is being developed for two indications: chronic heart failure and degenerative disc disease, where it is studied for moderate to severe chronic low back pain. Both programs have reached Phase 3 testing. The degenerative disc disease studies enroll adults 18 years and older, and the heart failure study enrolled adults in the United States and Canada.
Rexlemestrocel-L is developed by Mesoblast Limited, which trades under the ticker MESO. Mesoblast is the sponsor of the clinical program, including the Phase 3 studies in degenerative disc disease and chronic heart failure. The company has received an FDA RMAT designation for the asset.
Rexlemestrocel-L is in Phase 3 clinical development and is investigational. It has not been approved by the FDA. The program includes completed Phase 3 trials in degenerative disc disease and chronic heart failure, plus an active Phase 3 study in degenerative disc disease that is no longer recruiting participants.
Rexlemestrocel-L has been studied in three Phase 3 trials. NCT06325566 is an active, not recruiting Phase 3 study of Rexlemestrocel-L combined with HA in moderate to severe chronic low back pain. NCT02412735 was a completed Phase 3 study in chronic low back pain, and NCT02032004 was a completed Phase 3 study in chronic heart failure.