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Mesenchymal Stem Cells
Mesenchymal Stem Cells is a Cell therapy Biologic drug developed by Ottawa Hospital Research Institute. It is currently in Phase 3 development for Graft-versus-host disease (GVHD), Tissue repair and regeneration, Inflammatory conditions. Also known as: Autologous MSC, MSC, MSCs, mesenchymal stomal cells.
Mesenchymal stem cells promote tissue repair and modulate immune responses through secretion of anti-inflammatory factors and differentiation into specialized cell types.
Mesenchymal Stem Cells (MSCs) are a type of somatic cell used in supplemental therapy, which has been studied in various clinical trials for conditions such as uremia, COVID-19, and knee osteoarthritis. MSCs have been administered through transplantations of stromal vascular fraction (SVF) or extracellular vesicles derived from bone marrow, with the goal of treating these conditions.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Mesenchymal Stem Cells |
|---|---|
| Also known as | Autologous MSC, MSC, MSCs, mesenchymal stomal cells, Mscs |
| Sponsor | Ottawa Hospital Research Institute |
| Drug class | Cell therapy |
| Modality | Biologic |
| Therapeutic area | Regenerative Medicine, Immunology |
| Phase | Phase 3 |
Mechanism of action
MSCs are multipotent stromal cells that can differentiate into various cell lineages (osteocytes, chondrocytes, adipocytes) to replace damaged tissue. They also secrete immunomodulatory cytokines and growth factors that reduce inflammation, promote angiogenesis, and suppress pathogenic immune responses, making them suitable for regenerative and immunological applications.
Approved indications
- Graft-versus-host disease (GVHD)
- Tissue repair and regeneration
- Inflammatory conditions
Common side effects
- Infusion-related reactions
- Infection
- Immunogenicity
Key clinical trials
- Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue (PHASE1)
- A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD (NA)
- Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments (PHASE2)
- cfMSC Therapy for Diabetes (PHASE1, PHASE2)
- Exosomes Effect on Visual Function in CVI
- Study on the Safety and Efficacy of Intratympanic Injection of Small Extracellular Vesicles Derived From Mesenchymal Stem Cells in Severe and Profound Sudden Sensorineural Hearing Loss (PHASE1, PHASE2)
- cfMSC Stem Cell Therapy Targeting COPD (PHASE1, PHASE2)
- Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells (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:
- Mesenchymal Stem Cells CI brief — competitive landscape report
- Mesenchymal Stem Cells updates RSS · CI watch RSS
- Ottawa Hospital Research Institute portfolio CI
Frequently asked questions about Mesenchymal Stem Cells
What is Mesenchymal Stem Cells?
How does Mesenchymal Stem Cells work?
What is Mesenchymal Stem Cells used for?
Who makes Mesenchymal Stem Cells?
Is Mesenchymal Stem Cells also known as anything else?
What drug class is Mesenchymal Stem Cells in?
What development phase is Mesenchymal Stem Cells in?
What are the side effects of Mesenchymal Stem Cells?
Related
- Drug class: All Cell therapy drugs
- Manufacturer: Ottawa Hospital Research Institute — full pipeline
- Therapeutic area: All drugs in Regenerative Medicine, Immunology
- Indication: Drugs for Graft-versus-host disease (GVHD)
- Indication: Drugs for Tissue repair and regeneration
- Indication: Drugs for Inflammatory conditions
- Also known as: Autologous MSC, MSC, MSCs, mesenchymal stomal cells, Mscs
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing