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Human Mesenchymal Stromal Cells
Human Mesenchymal Stromal Cells is a Biologic drug developed by Michael A. Matthay. It is currently in Phase 2 development. Also known as: hMSCs.
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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 | Human Mesenchymal Stromal Cells |
|---|---|
| Also known as | hMSCs |
| Sponsor | Michael A. Matthay |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD (NA)
- Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis (PHASE3)
- Safety and Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis in Patients With End-Stage Diabetic Kidney Disease (PHASE1, PHASE2)
- Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Injection in Patients With Decompensated Hepatitis B Cirrhosis (PHASE1, PHASE2)
- A Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for the Treatment of Severe Acute Respiratory Distress Syndrome (PHASE1, PHASE2)
- Interferon γ-Primed Mesenchymal Stromal Cells as Prophylaxis for Acute Graft v Host Disease (PHASE1)
- Tolerance by Engaging Antigen During Cellular Homeostasis (PHASE1)
- Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cells (IxCell hUC-MSC-S) in the Treatment of Ischemic Stroke (PHASE1)
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:
- Human Mesenchymal Stromal Cells CI brief — competitive landscape report
- Human Mesenchymal Stromal Cells updates RSS · CI watch RSS
- Michael A. Matthay portfolio CI
Frequently asked questions about Human Mesenchymal Stromal Cells
What is Human Mesenchymal Stromal Cells?
Who makes Human Mesenchymal Stromal Cells?
Is Human Mesenchymal Stromal Cells also known as anything else?
What development phase is Human Mesenchymal Stromal Cells in?
Related
- Manufacturer: Michael A. Matthay — full pipeline
- Also known as: hMSCs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing