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Mesenchymal Stem Cells Derived Exosomes
Mesenchymal Stem Cells Derived Exosomes is a Biologic drug developed by Tehran University of Medical Sciences. It is currently in Phase 1 development.
Mesenchymal Stem Cells Derived Exosomes have been studied in clinical trials for various conditions, including Alzheimer Disease, Acute Respiratory Distress Syndrome, Dry Eye, Anti Aging, and Peripheral Neuropathy. They have been administered via nasal drip in low, mild, and high dosages in these trials, with the goal of evaluating their safety and efficacy.
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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 Cells Derived Exosomes |
|---|---|
| Sponsor | Tehran University of Medical Sciences |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- Hypokalaemia
- Hypotension
- Anaemia
- Leukocytosis
- Thrombocytosis
- Diarrhoea
- Oral Candidiasis
- Anxiety
- Hypoalbuminaemia
- Hyponatraemia
- Atrial Fibrillation
- Blood Glucose Increased
Key clinical trials
- Exosomes Effect on Visual Function in CVI
- Safety and Feasibility of Nasal Delivery of Human Dental Follicle Mesenchymal Stem Cell-Derived Exosomes for Negative Symptoms in Treatment-Resistant Schizophrenia: A Pilot Study (EARLY_PHASE1)
- Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction (PHASE2, PHASE3)
- Evaluation of Neuroinduced Mesenchymal Stem Cells and Mesenchymal Stem Cell-Derived Exosomes in Patients With Parkinsonism (PHASE2)
- Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality (PHASE3)
- Evaluation of the Safety and Preliminary Efficacy of Neuroinduced Mesenchymal Stem Cells and Exosome Therapy in Patients With Spinocerebellar Palsy (PHASE1, PHASE2)
- The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease (PHASE1, PHASE2)
- Extracellular Vesicle Treatment for Acute Respiratory Distress Syndrome (ARDS) (EXTINGUISH ARDS) (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 Cells Derived Exosomes CI brief — competitive landscape report
- Mesenchymal Stem Cells Derived Exosomes updates RSS · CI watch RSS
- Tehran University of Medical Sciences portfolio CI
Frequently asked questions about Mesenchymal Stem Cells Derived Exosomes
What is Mesenchymal Stem Cells Derived Exosomes?
Who makes Mesenchymal Stem Cells Derived Exosomes?
What development phase is Mesenchymal Stem Cells Derived Exosomes in?
What are the side effects of Mesenchymal Stem Cells Derived Exosomes?
Related
- Manufacturer: Tehran University of Medical Sciences — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing