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Also known as Prochymal®, Adult human mesenchymal stem cells, ex-vivo cultured adult human mesenchymal stem cells, hMSCs
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 being developed for steroid-refractory acute graft versus host disease, specifically Grade B acute GVHD, in pediatric patients who have failed to respond to steroid treatment. It is a cell therapy studied in this hematology indication.
Remestemcel-L is being developed by Mesoblast Limited, which trades under the ticker MESO. The company is the sponsor of the clinical program for this cell therapy in acute graft versus host disease.
Remestemcel-L is in Phase 3 clinical development. It is an investigational cell therapy and has not been approved by the FDA. The Phase 3 program includes completed trials in pediatric patients with steroid-refractory acute GVHD.
Remestemcel-L has been studied in two completed Phase 3 trials: NCT02336230, which enrolled 55 pediatric participants with Grade B, C, or D acute GVHD, and NCT02652130, a safety follow-up study that enrolled 32 pediatric participants. Both trials were conducted in the United States.
Remestemcel-L is an ex-vivo cultured adult human mesenchymal stromal cell therapy. It is administered as a cell therapy for steroid-refractory acute graft versus host disease, though the specific molecular target has not been disclosed.