Finished product reference
Human Allogenic Umbilical Cord Tissue-derived Mesenchymal Stromal Cells
Injection, Suspension · Parenteral · 30000000 cells/3mL
- List code
- 53663
- Pharmacologic class
- Allogeneic cell therapy (mesenchymal stromal cells); advanced therapy medicinal product
What it is and how it works
Culture-expanded mesenchymal stromal cells isolated from donor umbilical cord tissue. They act mainly through paracrine release of anti-inflammatory and trophic factors, modulating T-cell, macrophage and dendritic-cell responses and supporting tissue repair, rather than by long-term engraftment.
Indications
Used under specialist and clinical-trial or hospital-exemption protocols for immune-mediated and degenerative conditions, such as steroid-refractory graft-versus-host disease and selected inflammatory or orthopaedic indications; approved indications vary by product and jurisdiction.
Dosage and administration (summary)
Dose (cells per kg) and schedule are individualised by the specialist according to the product protocol; given by intravenous infusion or local injection.
Contraindications
Hypersensitivity to the cells or to excipients (e.g. dimethyl sulfoxide, human albumin); active uncontrolled infection.
Warnings and precautions
Infusion reactions, including fever and hypersensitivity, may occur; DMSO-containing products may cause nausea and odour. Theoretical risks include transmission of infection and effects on tumour growth; long-term safety data are limited. Thaw and administer strictly according to the product instructions.
Storage and supply
Usually stored cryopreserved in the vapour phase of liquid nitrogen (≤ −150 °C) and thawed immediately before use, per product instructions.
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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