7 completed, 4 terminated, 1 unknown, 1 withdrawn. 9 Phase 2, 4 Phase 1, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 5, Terminated 2, Unknown 1, Withdrawn 1 |
| Phase 1 | 4 | Completed 3, Terminated 1 |
| Phase 3 | 3 | Terminated 2, Completed 1 |
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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 |
|---|---|---|---|---|---|---|
| MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome MultiStem, Placebo - Trauma, Adult Stem Cells | Phase 2 | Unknown | Healios K.K. | 156 | 2020-11-09 | 2024-05-24 |
| MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) MultiStem, Placebo - ARDS | Phase 2 / Phase 3 | Terminated | Healios K.K. | 22 | 2020-04-28 | 2026-10-16 |
| Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome HLCM051 - Respiratory Distress Syndrome, Adult | Phase 2 | Completed | Healios K.K. | 35 | 2019-01-01 | 2024-01-17 |
| MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study MultiStem, Placebo - Ischemic Stroke | Phase 3 | Terminated | Healios K.K. | 206 | 2018-07-28 | 2026-08-11 |
| Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements HLCM051, Placebo - Stroke, Acute | Phase 2 / Phase 3 | Completed | Healios K.K. | 206 | 2017-11-15 | 2024-01-17 |
| A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome MultiStem, Placebo - Acute Respiratory Distress Syndrome | Phase 1 / Phase 2 | Completed | Healios K.K. | 36 | 2016-01-01 | 2019-11-20 |
| A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction AMI MultiStem cells, Sham - Heart Attack, NSTEMI | Phase 2 | Terminated | Healios K.K. | 34 | 2015-12-01 | 2021-07-22 |
| Safety Study of Multipotent Progenitor Cells for Immunomodulation Therapy After Liver Transplantation MultiStem - Liver Transplantation | Phase 1 | Terminated | Prof. Dr. Marc-H. Dahlke, Ph. D. | 3 | 2013-04-01 | 2018-08-17 |
| Study to Examine the Effects of MultiStem in Ischemic Stroke MultiStem, Placebo - Ischemic Stroke | Phase 2 | Completed | Healios K.K. | 134 | 2011-10-01 | 2016-08-02 |
| A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis placebo, MultiStem low dose, MultiStem high dose - Colitis, Ulcerative | Phase 2 | Completed | Pfizer | 105 | 2011-02-01 | 2016-02-23 |
| A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and Safety ATHX-105 phosphate, Placebo - Obesity | Phase 2 | Withdrawn | Healios K.K. | 2008-09-01 | 2015-06-02 | |
| Safety Study of MultiStem® in Patients With Acute Leukemia, Chronic Myeloid Leukemia, or Myelodysplasia MultiStem® - Hematologic Malignancies | Phase 1 | Completed | Healios K.K. | 36 | 2008-07-01 | 2012-01-05 |
| Safety Study of AMI MultiStem® to Treat Heart Attacks AMI MultiStem® - Acute Myocardial Infarction | Phase 1 | Completed | Healios K.K. | 25 | 2008-05-01 | 2012-05-11 |
Ischemic Stroke (2) · Myocardial Infarction (2) · Respiratory Distress Syndrome (2) · Anemia, Refractory, with Excess of Blasts (1) · Body Weight (1) · COVID-19 (1) · Colitis, Ulcerative (1) · Dyspnea (1) · Graft vs Host Disease (1) · Hematologic Neoplasms (1) · Leukemia (1) · Metabolic Diseases (1) · Non-ST Elevated Myocardial Infarction (1) · Nutrition Disorders (1) · Obesity (1)
United States (9) · Belgium (2) · Germany (2) · Japan (2) · United Kingdom (2) · Canada (1) · Hungary (1) · Italy (1) · Slovakia (1) · Sweden (1) · Taiwan (1)
Marc Penn, MD (2) · Robert W Mays, PhD (2) · Charles Cox, MD (1) · Eric Jenkins, MD (1) · Geoff Bellingan, MD (1) · Hillard Lazarus, MD (1) · Kazuya Ichikado, M.D., Ph.D. (1) · Richard Maziarz, MD (1) · Satoru Hashimoto, M.D., Ph.D. (1) · Steven Devine, MD (1) · Warren Sherman, MD (1)
PMID 22052917, PMID 28320635, PMID 29134924, PMID 34811567, PMID 37608287, PMID 38227308
2009 (1), R44HL117572 (1)