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Stem Cells,Mesenchymal
Stem Cells,Mesenchymal is a Stem cell therapy Biologic drug developed by Ain Shams Maternity Hospital. It is currently in Phase 3 development for Treatment of graft-versus-host disease.
Mesenchymal stem cells are used to modulate the immune system and promote tissue repair.
Mesenchymal stem cells, specifically those derived from bone marrow or stromal vascular fraction, have been studied in clinical trials for various conditions, including uremia, COVID-19, postviral syndrome, dyspnea, and knee osteoarthritis. These cells, or their extracellular vesicles, have been used as interventions in clinical trials, with some studies examining their use in transplantation procedures, such as kidney transplantation.
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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).
| 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 | Stem Cells,Mesenchymal |
|---|---|
| Sponsor | Ain Shams Maternity Hospital |
| Drug class | Stem cell therapy |
| Modality | Biologic |
| Therapeutic area | Regenerative medicine |
| Phase | Phase 3 |
Mechanism of action
Mesenchymal stem cells have anti-inflammatory properties and can differentiate into various cell types to replace damaged tissues. They also secrete factors that promote tissue repair and regeneration.
Approved indications
- Treatment of graft-versus-host disease
Common side effects
- Graft-versus-host disease
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:
- Stem Cells,Mesenchymal CI brief — competitive landscape report
- Stem Cells,Mesenchymal updates RSS · CI watch RSS
- Ain Shams Maternity Hospital portfolio CI
Frequently asked questions about Stem Cells,Mesenchymal
What is Stem Cells,Mesenchymal?
How does Stem Cells,Mesenchymal work?
What is Stem Cells,Mesenchymal used for?
Who makes Stem Cells,Mesenchymal?
What drug class is Stem Cells,Mesenchymal in?
What development phase is Stem Cells,Mesenchymal in?
What are the side effects of Stem Cells,Mesenchymal?
Related
- Drug class: All Stem cell therapy drugs
- Manufacturer: Ain Shams Maternity Hospital — full pipeline
- Therapeutic area: All drugs in Regenerative medicine
- Indication: Drugs for Treatment of graft-versus-host disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing