Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Remestemcel-L · 2 trials · 6 indications
The overall survival rate is defined as the percentage of participants alive at the given time point. OS is defined as the time to death from the start of drug therapy.
ORR was defined as the percentage of participants who had achieved overall response. Overall response was defined as complete response (CR) plus partial response (PR) as per aGVHD response criteria. CR was defined as resolution of aGVHD in all involved organs. PR was defined as organ improvement of at least 1 stage without worsening of any other organ.
| Arm | Type | Description |
|---|---|---|
| Safety population | EXPERIMENTAL | All participants who were enrolled and had received at least 1 dose of remestemcel-L in Study MSB-GVHD001. |
| Remestemcel-L 2×10^6 MSCs/kg | EXPERIMENTAL | Participants were treated with intravenous (IV) remestemcel-L at a dose of 2×10\^6 mesenchymal stromal cells (MSCs)/kilogram (kg) actual body weight at Screening, twice per week, for each of 4 consecutive weeks (initial therapy) given at least 3 days apart and no more than 5 days apart for any infusion. Eligible participants received an additional once per week infusion, for each of 4 consecutive weeks (continued therapy) of remestemcel-L and twice per week infusions, for each of 4 consecutive weeks (aGVHD flare therapy) of remestemcel-L at the same initial therapy dose of 2×10\^6 MSCs/kg actual body weight at Screening. |
| Name | Type | Description |
|---|---|---|
| Remestemcel-L | BIOLOGICAL | No intervention was given in Study MSB-GVHD002 (NCT02652130). It was a safety follow-up trial of remestemcel-L-treated participants from Study MSB-GVHD001. |
Inclusion Criteria: * Participants must have participated in MSB-GVHD001 and have received at least one infusion of remestemcel-L. * Participant or participant's authorized representative must be capable of providing written informed consent. Assent, if applicable, must also be collected when requi...
Remestemcel-L is an investigational cell therapy being studied for the treatment of Grade B acute graft versus host disease (aGVHD), a complication that can occur after a stem cell transplant. It is being evaluated in pediatric patients who have failed to respond to steroid treatment for this condition.
Remestemcel-L is being developed by Mesoblast Limited, a biopharmaceutical company. Mesoblast is publicly traded on the NASDAQ under the ticker symbol MESO.
Remestemcel-L is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. Clinical trials are being conducted to evaluate its safety and effectiveness in treating acute graft versus host disease.
Remestemcel-L has been studied in two completed Phase 3 clinical trials. The primary trial, NCT02336230, enrolled 55 pediatric participants with steroid-refractory acute graft versus host disease. A follow-up safety study, NCT02652130, enrolled 32 participants. Both trials were conducted in the United States.
Remestemcel-L is a preparation of ex-vivo cultured adult human mesenchymal stromal cells. These cells are thought to modulate the immune response, potentially reducing the inflammation that drives graft versus host disease. The exact mechanism of action is still being studied in clinical trials.
No, Remestemcel-L is not a monoclonal antibody. It is a cell therapy consisting of cultured adult human mesenchymal stromal cells. While it is sometimes classified under the modality of monoclonal antibody in some databases, its mechanism is based on cellular therapy rather than antibody-based targeting.