12 completed, 5 no longer available, 3 terminated. 8 Phase 2, 7 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 6, Terminated 2 |
| Phase 3 | 7 | Completed 6, Terminated 1 |
| Phase 1 | 2 | Terminated 2 |
Follow remestemcel-l: new trials by email Literature Review of remestemcel-l trials Research Report on remestemcel-l
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC) Remestemcel-L, Placebo - Ulcerative Colitis | Phase 1 / Phase 2 | Terminated | The Cleveland Clinic | 7 | 2020-11-10 | 2026-04-16 |
| Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis Remestemcel-L, Placebo - Crohn Colitis | Phase 1 / Phase 2 | Terminated | The Cleveland Clinic | 7 | 2020-11-04 | 2026-04-16 |
| MSCs in COVID-19 ARDS Remestemcel-L, Placebo - Mesenchymal Stromal Cells, Remestemcel-L | Phase 3 | Terminated | Icahn School of Medicine at Mount Sinai | 223 | 2020-04-30 | 2022-04-25 |
| Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD Remestemcel-L - Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease | Phase 3 | Completed | Mesoblast, Inc. | 32 | 2015-10-28 | 2022-03-16 |
| A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute Graft-Versus-Host Disease (aGVHD) remestemcel-L - Grade B aGVHD, Grade C aGVHD | Phase 3 | Completed | Mesoblast, Inc. | 55 | 2015-06-04 | 2022-03-17 |
| Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease Prochymal® - Crohn's Disease | Phase 3 | Completed | Mesoblast, Inc. | 73 | 2010-11-29 | 2026-03-11 |
| Prochymal® (Human Adult Stem Cells) Intravenous Infusion Following Acute Myocardial Infarction (AMI) Prochymal®, Placebo - Myocardial Infarction | Phase 2 | Completed | Mesoblast, Inc. | 220 | 2009-03-30 | 2026-03-11 |
| PROCHYMAL® (Human Adult Stem Cells) for the Treatment of Recently Diagnosed Type 1 Diabetes Mellitus (T1DM) PROCHYMAL®, Placebo - Type 1 Diabetes Mellitus, Type 1 Diabetes | Phase 2 | Completed | Mesoblast, Inc. | 63 | 2008-06-11 | 2026-03-11 |
| PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Prochymal™, Placebo - Pulmonary Disease, Chronic Obstructive, Pulmonary Emphysema | Phase 2 | Completed | Mesoblast, Inc. | 62 | 2008-03-20 | 2026-03-11 |
| Efficacy and Safety of Prochymal® Infusion in Combination With Corticosteroids for the Treatment of Newly Diagnosed Acute Graft Versus Host Disease (GVHD) Prochymal®, Placebo, Corticosteroid - Graft Versus Host Disease | Phase 3 | Completed | Mesoblast, Inc. | 192 | 2008-01-31 | 2022-01-19 |
| Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease Prochymal®, Placebo - Crohn's Disease | Phase 3 | Completed | Mesoblast, Inc. | 330 | 2007-09-17 | 2026-03-11 |
| Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD) Prochymal®, Placebo, Standard of Care for GVHD - Graft Versus Host Disease | Phase 3 | Completed | Mesoblast, Inc. | 260 | 2006-08-17 | 2022-02-10 |
| Prochymal™ Adult Human Mesenchymal Stem Cells for Treatment of Moderate-to-severe Crohn's Disease Prochymal™ adult human mesenchymal stem cells, adult human mesenchymal stem cells - Crohn's Disease | Phase 2 | Completed | Mesoblast, Inc. | 10 | 2006-03-13 | 2020-04-02 |
| Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants Prochymal - Graft Versus Host Disease | Phase 2 | Completed | Mesoblast, Inc. | 11 | 2005-11-18 | 2025-10-30 |
| Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD) Prochymal® - 2 Million cells/kg, Prochymal®- 8 Million cells/kg, Methylprednisolone - Graft Vs Host Disease | Phase 2 | Completed | Mesoblast, Inc. | 32 | 2005-04-27 | 2022-01-31 |
| Prochymal® Expanded Access for Adults Who Have Failed Steroid Treatment for Acute Graft Versus Host Disease (GVHD) Prochymal® - Graft-Versus-Host Disease | No longer available | Mesoblast, Inc. | 2020-03-09 | |||
| Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease PROCHYMAL (remestemcel-L) - Crohn's Disease | No longer available | Mesoblast, Inc. | 2020-03-10 | |||
| Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Infection Remestemcel-L - Moderate to Severe Acute Respiratory Distress Syndrome Associated With COVID-19 | No longer available | Mesoblast International Sàrl | 2021-02-18 | |||
| Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD remestemcel-L - Graft vs Host Disease, Graft-Versus-Host Disease | No longer available | Mesoblast, Inc. | 2020-03-09 | |||
| Intermediate-size Expanded Access Program (EAP), Mesenchymal Stromal Cells (MSC) for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19) Remestemcel-L, Hydrocortisone, Diphenhydramine - Multisystem Inflammatory Syndrome in Children (MIS-C) Associated With Coronavirus Disease (COVID-19) | No longer available | Mesoblast International Sàrl | 2025-10-31 |
Graft vs Host Disease (6) · Crohn Disease (5) · COVID-19 (2) · Bronchitis, Chronic (1) · Colitis, Ulcerative (1) · Coronavirus Infections (1) · Cytokine Release Syndrome (1) · Diabetes Mellitus, Type 1 (1) · Insulin Resistance (1) · Leukemia (1) · Lymphoma (1) · Myocardial Infarction (1) · Pulmonary Disease, Chronic Obstructive (1) · Pulmonary Emphysema (1) · Respiratory Distress Syndrome (1)
Mesoblast, Inc. (15) · Mesoblast International Sàrl (2) · The Cleveland Clinic (2) · Icahn School of Medicine at Mount Sinai (1)
United States (19) · Canada (5) · Australia (4) · New Zealand (2) · Italy (1) · Switzerland (1) · United Kingdom (1)
Christopher James, PA (6) · Mahboob Rahman, MD (5) · Christopher James (2) · Amy Lightner (1) · Amy Lightner, MD (1) · Annetine C Gelijns, PhD (1) · Elizabeth Burke, ANP-C (1) · Ken Borow, MD (1) · Kenneth M. Borow, MD (1) · Mahboob Rahman (1) · Michael Mack, MD (1) · Peter Smith, MD (1)
PMID 19539211, PMID 22292600, PMID 23172272, PMID 27515308, PMID 32018062, PMID 32044400, PMID 33579813, PMID 33964910