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MultiStem®
MultiStem is a cell therapy derived from bone marrow-derived mesenchymal stem cells that modulates immune responses and promotes tissue repair.
MultiStem is a cell therapy derived from bone marrow-derived mesenchymal stem cells that modulates immune responses and promotes tissue repair. Used for Acute respiratory distress syndrome (ARDS), Acute myocardial infarction.
At a glance
| Generic name | MultiStem® |
|---|---|
| Sponsor | Healios K.K. |
| Drug class | Cell therapy |
| Modality | Biologic |
| Therapeutic area | Immunology, Regenerative Medicine |
| Phase | Phase 3 |
Mechanism of action
MultiStem consists of allogeneic mesenchymal stem cells that are expanded and cryopreserved. These cells work through immunomodulatory and anti-inflammatory mechanisms, secreting bioactive factors that reduce inflammation, promote angiogenesis, and support tissue regeneration. The therapy is designed to address acute inflammatory conditions by restoring immune homeostasis and facilitating healing.
Approved indications
- Acute respiratory distress syndrome (ARDS)
- Acute myocardial infarction
Common side effects
- Infusion-related reactions
- Fever
- Hypoxemia
Key clinical trials
- MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome (PHASE2)
- Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome (PHASE2)
- Treatment Evaluation of Acute Stroke for Using in Regenerative Cell Elements (PHASE2, PHASE3)
- MultiStem® Administration for Stroke Treatment and Enhanced Recovery Study (PHASE3)
- MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) (PHASE2, PHASE3)
- A Phase 2 Trial of AMI MultiStem® Therapy in Subjects With Non-ST Elevation Acute Myocardial Infarction (PHASE2)
- A Phase 1/2 Study to Assess MultiStem® Therapy in Acute Respiratory Distress Syndrome (PHASE1, PHASE2)
- Study to Examine the Effects of MultiStem in Ischemic Stroke (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MultiStem® CI brief — competitive landscape report
- MultiStem® updates RSS · CI watch RSS
- Healios K.K. portfolio CI