Finished product reference
Placenta Derived Stromal Mesenchymal Cells
Injection, Suspension · Parenteral · 2000000 cm2/1mL · 5 mL
- List code
- 53660
- Pharmacologic class
- Cell-based therapy (allogeneic placenta-derived mesenchymal stromal cells; advanced therapy medicinal product)
What it is and how it works
Mesenchymal stromal cells isolated from placental tissue are multipotent, low-immunogenicity cells that act mainly through paracrine secretion of growth factors, cytokines and extracellular vesicles, exerting immunomodulatory, anti-inflammatory, pro-angiogenic and tissue-repair effects rather than by long-term engraftment.
Indications
Use is limited to specific nationally authorised indications, clinical trials or specialist protocols (studied, for example, in graft-versus-host disease, critical limb ischaemia, inflammatory and degenerative conditions and wound healing); efficacy varies by product and indication.
Dosage and administration (summary)
Dosing is individualised: cell dose, route and schedule are determined by the treating specialist according to the authorised protocol for the specific product.
Contraindications
Hypersensitivity to product components (including residual reagents or cryoprotectants such as DMSO), active uncontrolled infection and active malignancy, according to the specific product information.
Warnings and precautions
Must be administered only in specialised centres with traceability, cold-chain and thawing procedures as specified. Risks include infusion reactions, transmission of infection, thromboembolic events and theoretical risks of ectopic tissue formation or tumour promotion. Long-term safety data are limited.
Storage and supply
Store and transport according to the product-specific requirements, usually cryopreserved in the vapour phase of liquid nitrogen or as specified by the manufacturer.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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