Approval Probability
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Prochymal adult human mesenchymal stem cells · 2 trials · 1 indication
The CDAI is a composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more disease activity.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| PROCHYMAL Low dose | ACTIVE_COMPARATOR | Low dose (total of 600 million cells). |
| PROCHYMAL High dose | ACTIVE_COMPARATOR | High dose (total of 1200 cells). |
| High dose | EXPERIMENTAL | High dose (8 million cells per kg of body weight) |
| Low dose | EXPERIMENTAL | Low dose: 2 million cells per kg body weight |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | - |
| PROCHYMAL adult human mesenchymal stem cells | DRUG | intravenous infusion four times over two weeks; possibly repeated once |
| Prochymal™ adult human mesenchymal stem cells | DRUG | Cells in plasmalyte and containing dimethylsulfoxide |
| adult human mesenchymal stem cells | DRUG | two infusions, one week apart, each comprising adult human mesenchymal stem cells |
Inclusion Criteria: * Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28 Exclusion Criteria: * Substance abuse * Failure to receive full dose of all interventions in Protocol 603
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 6 | PHASE3 | Duvakitug |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Risankizumab, Risankizumab On-Body Injector |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 16 | PHASE3 | Vedolizumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| Amgen Inc. | AMGN | 1 | N/A | Undisclosed |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Prochymal adult human mesenchymal stem cells is an investigational therapy being studied for the treatment of moderate-to-severe Crohn's Disease, including treatment-resistant cases. It is a cell-based product derived from adult human mesenchymal stem cells. The therapy is currently in clinical development and has not been approved by regulatory authorities.
Prochymal adult human mesenchymal stem cells is being developed by Mesoblast Limited, a biopharmaceutical company. Mesoblast is focused on developing regenerative medicine products. The company's stock is traded under the ticker symbol MESO on the NASDAQ exchange.
Prochymal adult human mesenchymal stem cells is in Phase 3 clinical development for Crohn's Disease. The Phase 3 trial, NCT00543374, has been completed. The therapy is investigational and has not received FDA approval. It is still undergoing clinical evaluation to determine its safety and efficacy.
Prochymal adult human mesenchymal stem cells has been studied in two completed clinical trials. The first, NCT00294112, was a Phase 2 study in 10 patients with moderate-to-severe Crohn's Disease in the United States. The second, NCT00543374, was a Phase 3 study in 98 patients with treatment-resistant moderate-to-severe Crohn's Disease in the United States and Canada.
Prochymal adult human mesenchymal stem cells is a specific product name for a therapy consisting of adult human mesenchymal stem cells. The product is also referred to as PROCHYMAL in clinical trial documentation. It is being developed by Mesoblast Limited for the treatment of Crohn's Disease.