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Also known as Remestemcel-L, ex-vivo cultured adult human mesenchymal stem cells, hMSCs
Prochymal- 2 Million cells/kg · 3 trials · 7 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. |
| Prochymal® - 2 Million cells/kg | ACTIVE_COMPARATOR | Participants will receive Prochymal® consisting of 2 million hMSCs/kg actual body weight, intravenously (IV) on Days 1 and 4 along with daily standard of care which includes methylprednisolone 2 milligrams (mg)/kg IV or prednisone 2.5 mg/kg orally. Participants will also continue cyclosporine, tacrolimus, and/or mycophenolate mofetil (MMF) at full therapeutic doses. |
| Prochymal® - 8 Million cells/kg | ACTIVE_COMPARATOR | Participants will receive Prochymal® consisting of 8 million hMSCs/kg actual body weight IV on Days 1 and 4 along with daily standard of care which includes methylprednisolone 2 mg/kg IV or prednisone 2.5 mg/kg orally. Participants will also continue cyclosporine, tacrolimus, and/or mycophenolate mofetil (MMF) at full therapeutic doses. |
| 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. |
| Prochymal® - 2 Million cells/kg | DRUG | 2 million hMSCs/kg actual body weight, IV on study Days 1 and 4 |
| Prochymal®- 8 Million cells/kg | DRUG | 8 million hMSCs/kg actual body weight IV on study Days 1 and 4 |
| Methylprednisolone | DRUG | Methylprednisolone 2 mg/kg administered intravenously. |
| Prednisone | DRUG | Prednisone 2.5 mg/kg administered orally. |
| Cyclosporine | DRUG | Administered as prescribed by the caregiver. |
| Tacrolimus | DRUG | Administered as prescribed by the caregiver. |
| Mycophenolate Mofetil | DRUG | Administered as prescribed by the caregiver. |
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...
Top 4 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Belumosudil |
| Incyte Corporation | INCY | 10 | PHASE3 | INCA034176, Ruxolitinib, Axatilimab |
| Johnson & Johnson | JNJ | 1 | PHASE3 | Ibrutinib |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
Prochymal - 2 Million cells/kg is an investigational therapy being studied for the treatment of graft versus host disease (GVHD), a serious complication that can occur after stem cell or bone marrow transplantation. It is being developed by Mesoblast Limited and is in Phase 2 clinical development.
Prochymal - 2 Million cells/kg is being developed by Mesoblast Limited, an Australian regenerative medicine company listed on the Nasdaq under the ticker MESO. Mesoblast is responsible for the clinical development program for this asset.
Prochymal - 2 Million cells/kg is in Phase 2 clinical development. The only listed trial for this asset is a completed Phase 2 study, and there are currently no active trials. It is an investigational product and has not been approved by the FDA.
Prochymal - 2 Million cells/kg has been evaluated in one completed Phase 2 clinical trial, NCT00136903, titled "Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)." The trial enrolled 32 participants in the United States and was active-controlled and randomized.
Yes, Prochymal - 2 Million cells/kg is also known as Prochymal® - 2 Million cells/kg. The name refers to a specific dosing strength of the Prochymal product, which is being developed by Mesoblast Limited for graft versus host disease.