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Also known as PROCHYMAL
Prochymal adult human mesenchymal stem cells · 10 trials · 10 indications
Crohn's Disease Activity Index (CDAI) at or below 150 and increase in IBDQ
Treatment was considered a success if all of the following conditions were met: Achieved induction of a complete response (CR) within 28 days after first infusion; CR followed by 28 days maintenance of a clinically meaningful response defined as the response that did not require an increase in corticosteroid dose (methylprednisolone doses \>2 milligram/kilogram/day \[mg/kg/d\] or prednisone doses \>2.5 mg/kg/d) for more than 7 consecutive days; Did not require second line/escalation therapy through Study Day 56; and survived 90 study days.
A complete response was defined as complete resolution of all clinical signs of Graft versus host disease (GVHD)- that had to be maintained for at least 28 consecutive days (durable complete response \[DCR\]) within 100 days post first infusion.
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.
Responses included complete response (CR), partial response (PR), failure to respond. CR is defined as a complete resolution of graft-versus-host disease (GVHD). PR is defined as improvement in at least one organ by at least one full stage in the absence of progression in any other organ, or resolution of GVHD in at least one organ with a need for additional treatment because of abnormalities persisting in another organ. Failure to respond is defined as progression of GVHD.
| Arm | Type | Description |
|---|---|---|
| Prochymal® | EXPERIMENTAL | Infusions of Prochymal on days 42-45, 84-87, and 126-129 after first infusion in Protocol 603. Each infusion of PROCHYMAL (remestemcel-L) will contain 200 million cells. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive 6 infusions of placebo-matching Prochymal® intravenously (IV) during the first 4 weeks of the study. The first infusion will be administered within 72 hours of the start of systemic corticosteroid therapy. Participants will receive 4 infusions during the first 2 weeks (twice weekly at least 3 days apart), followed by 2 infusions administered once weekly over the subsequent 2 weeks up to Day 28. |
| Prochymal® 2x10^6 hMSC/kg | ACTIVE_COMPARATOR | Participants will receive 6 infusions of Prochymal® 2x10\^6 human mesenchymal stem cells (hMSC)/kg IV during the first 4 weeks of the study. The first infusion will be administered within 72 hours of the start of systemic corticosteroid therapy. Participants will receive 4 infusions during the first 2 weeks (twice weekly at least 3 days apart), followed by 2 infusions administered once weekly over the subsequent 2 weeks up to Day 28. |
| PROCHYMAL Low dose | ACTIVE_COMPARATOR | Low dose (total of 600 million cells). |
| PROCHYMAL High dose | ACTIVE_COMPARATOR | High dose (total of 1200 cells). |
| Prochymal® - Low dose | ACTIVE_COMPARATOR | Participants will receive a total dose of Prochymal® 600 x 10\^6 cells, IV infusion, on four days, once daily. |
| Prochymal® - High dose | ACTIVE_COMPARATOR | Participants will receive a total dose of Prochymal® 1200 x 10\^6 cells, IV infusion, on four days, once daily. |
| Prochymal | EXPERIMENTAL | PROCHYMAL® |
| Prochymal™ | EXPERIMENTAL | Participants received Prochymal™ a total of 400×10\^6 cells, intravenous (IV) infusions on Days 0, 30, 60, and 90. |
| 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 |
|---|---|---|
| Prochymal® | DRUG | PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603. |
| Placebo | OTHER | Placebo-matching Prochymal® intravenous infusion. |
| Corticosteroid | OTHER | Administration will be intravenously as prescribed by the caregiver. |
| PROCHYMAL adult human mesenchymal stem cells | DRUG | intravenous infusion four times over two weeks; possibly repeated once |
| Standard of Care for GVHD | DRUG | Institutionally defined standard of care (e.g., maintenance of steroid treatment and the addition of a second-line therapy) |
| Prochymal™ | DRUG | IV infusion of ex- vivo cultured adult human mesenchymal stem cells. |
| 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 |
| Prochymal | DRUG | Intravenous infusion of ex-vivo cultured adult human mesenchymal stem cells |
Inclusion Criteria: * Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010. * Participant successfully completed all screening asses...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, balinatunfib, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
Prochymal adult human mesenchymal stem cells is an investigational cell therapy developed by Mesoblast Limited for Crohn's Disease. It is being studied in patients with treatment-resistant moderate-to-severe Crohn's Disease. The product is administered as a cell-based treatment rather than a conventional small molecule or antibody drug.
Prochymal adult human mesenchymal stem cells is being studied for the treatment of Crohn's Disease, specifically treatment-resistant moderate-to-severe cases. Both registered trials enrolled adults aged 18 years and older with this gastrointestinal condition. It is an investigational therapy and is not established as a marketed treatment.
Prochymal adult human mesenchymal stem cells is developed by Mesoblast Limited, which trades under the ticker MESO. Mesoblast is the sponsor of the clinical program evaluating the cell therapy in Crohn's Disease across completed Phase 2 and Phase 3 studies.
Prochymal adult human mesenchymal stem cells has reached Phase 3 development for Crohn's Disease. Two trials are registered, one Phase 2 and one Phase 3, and both are completed. No trials are currently active, and the program remains investigational rather than approved.
Two completed trials are registered for Prochymal adult human mesenchymal stem cells. NCT00294112 was a Phase 2 study in moderate-to-severe Crohn's Disease conducted in the United States with 10 participants. NCT00543374 was a Phase 3 extended evaluation in treatment-resistant moderate-to-severe Crohn's Disease run in the United States and Canada with 98 participants.
Yes. Prochymal and Prochymal adult human mesenchymal stem cells refer to the same cell therapy product developed by Mesoblast Limited. The trademarked name Prochymal is used interchangeably with the full descriptive name in trial titles and program references for the Crohn's Disease studies.