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Mesenchymal stem cell therapy
Mesenchymal stem cell therapy is a Biologic drug developed by UNICEF. It is currently in Phase 1 development. Also known as: MSC.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 cell therapy |
|---|---|
| Also known as | MSC |
| Sponsor | UNICEF |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
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)
- 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)
- Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy (PHASE2)
- Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure (PHASE3)
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 cell therapy CI brief — competitive landscape report
- Mesenchymal stem cell therapy updates RSS · CI watch RSS
- UNICEF portfolio CI
Frequently asked questions about Mesenchymal stem cell therapy
What is Mesenchymal stem cell therapy?
Who makes Mesenchymal stem cell therapy?
Is Mesenchymal stem cell therapy also known as anything else?
What development phase is Mesenchymal stem cell therapy in?
Related
- Manufacturer: UNICEF — full pipeline
- Also known as: MSC
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing