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Donor mesenchymal stem cell infusions
Donor mesenchymal stem cell infusions is a Biologic drug developed by Masonic Cancer Center, University of Minnesota. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Donor mesenchymal stem cell infusions |
|---|---|
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
- Pyrexia
- Otitis media
- Fall
- Hand-foot-and-mouth disease
- Laboratory test abnormal
- Strabismus correction
- Infusion related reaction
- Hypoacusis
- Constipation
- Diarrhoea
- Vomiting
- Fatigue
Key clinical trials
- Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients (PHASE2)
- Umbilical Cord-derived Mesenchymal Stem Cell Infusion in the Management of Adult Liver Cirrhosis (PHASE1)
- Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines (PHASE1)
- Mesenchymal Stromal Cells in Living Donor Kidney Transplantation (PHASE2)
- MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs (PHASE2)
- Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation (PHASE1)
- Clinical Study on the Safety and Preliminary Efficacy of hUC-MSCs Intravenous Infusion Therapy for ARDS (PHASE1, PHASE2)
- Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function (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:
- Donor mesenchymal stem cell infusions CI brief — competitive landscape report
- Donor mesenchymal stem cell infusions updates RSS · CI watch RSS
- Masonic Cancer Center, University of Minnesota portfolio CI
Frequently asked questions about Donor mesenchymal stem cell infusions
What is Donor mesenchymal stem cell infusions?
Who makes Donor mesenchymal stem cell infusions?
What development phase is Donor mesenchymal stem cell infusions in?
What are the side effects of Donor mesenchymal stem cell infusions?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing