Approval Probability
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ML Risk
Rexlemestrocel-L+ HA mixture · 2 trials · 1 indication
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.
| 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). |
| 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 |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Mesoblast Limited Sponsored ADR | MESO | 1 | PHASE3 | Rexlemestrocel-L, HA mixture, Saline |
| Creative Medical Technology Holdings, Inc. | CELZ | 1 | PHASE1 | CELZ-201-DDT |
| Stryker Corporation | SYK | 2 | N/A | Undisclosed |
| Globus Medical Inc Class A | GMED | 6 | - | Undisclosed |
| Orthofix Medical, Inc. | OFIX | 1 | - | Undisclosed |
Rexlemestrocel-L is an investigational allogeneic cell therapy being studied for chronic heart failure and degenerative disc disease. In chronic heart failure, it is evaluated for its potential to improve heart function. For degenerative disc disease, it is being studied alone or combined with hyaluronic acid to treat chronic low back pain.
Rexlemestrocel-L is being developed by Mesoblast Limited, a biopharmaceutical company listed on NASDAQ under the ticker MESO. Mesoblast is conducting Phase 3 clinical trials of Rexlemestrocel-L for chronic heart failure and degenerative disc disease.
Rexlemestrocel-L is in Phase 3 clinical development. It has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the FDA. It is investigational and not yet approved for any indication.
Rexlemestrocel-L has been studied in several Phase 3 trials. NCT02032004 evaluated it for chronic heart failure with 565 participants. NCT02412735 studied it alone or with hyaluronic acid for degenerative disc disease with 404 participants. NCT06325566 is an active trial combining it with hyaluronic acid for chronic low back pain.
Yes, Rexlemestrocel-L + HA mixture refers to Rexlemestrocel-L combined with hyaluronic acid. This combination is being studied in clinical trials for degenerative disc disease and chronic low back pain, including the active trial NCT06325566.
Rexlemestrocel-L is an allogeneic mesenchymal precursor cell therapy. It is designed to modulate inflammatory and immune responses, though its specific molecular target is not defined. It is being investigated for its regenerative effects in heart failure and degenerative disc disease.