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Rexlemestrocel-L · 3 trials · 2 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.
| 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. |
| 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. |
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 ...
Rexlemestrocel-L is an investigational cell therapy being studied for Degenerative Disc Disease and Chronic Heart Failure. In clinical trials, it is evaluated for chronic low back pain associated with degenerative disc disease and for heart failure. It is in Phase 3 development and is not yet approved by the FDA.
Rexlemestrocel-L is being developed by Mesoblast Limited, a biopharmaceutical company traded on the NASDAQ under the ticker MESO. Mesoblast is conducting Phase 3 clinical trials to evaluate the safety and efficacy of Rexlemestrocel-L for degenerative disc disease and chronic heart failure.
Rexlemestrocel-L is in Phase 3 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA. The drug has received Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations from the FDA for its studied indications.
Rexlemestrocel-L has been studied in three Phase 3 trials. NCT02032004 evaluated it for chronic heart failure with 565 participants and is completed. NCT02412735 studied it for degenerative disc disease with 404 participants and is completed. NCT06325566 is an active, not recruiting trial for moderate to severe chronic low back pain with 300 participants.
Rexlemestrocel-L is also known as Rexlemestrocel-L + HA mixture, referring to the combination of the cell therapy with hyaluronic acid. Clinical trials have evaluated Rexlemestrocel-L alone or combined with hyaluronic acid for treating chronic low back pain associated with degenerative disc disease.
Rexlemestrocel-L is not FDA approved. It is an investigational drug currently in Phase 3 clinical trials for degenerative disc disease and chronic heart failure. The FDA has granted it Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations, which are intended to expedite development and review of promising therapies.