Description
Indication & Scope
Amimestrocel Injection treats steroid-refractory acute graft-versus-host disease (aGVHD) predominantly involving the digestive tract in patients aged 14 years and older.
- Mechanism: Allogeneic mesenchymal stem cells suppress overactive alloreactive immune cells, reduce inflammatory damage to gastrointestinal tissues and repair damaged mucosal tissue in acute GVHD.
- Drug class: Cell therapy biologic, immunomodulatory regenerative therapeutic agent.
- Clinical use: Second-line cell therapy for steroid-refractory gastrointestinal acute graft-versus-host disease.
| Generic Name | Amimestrocel Injection |
| Brand Name | RuiBoSheng |
| Ingredient | Amimestrocel Injection |
| Dosage Form | Injection |
| Package | 12ml: 6.0 × 10 ^ 7 cells*1 bag |
| Conditions Treated | Steroid-refractory acute graft-versus-host disease with primary gastrointestinal involvement in patients ≥14 years old |
| Taboos | Severe hypersensitivity to cell preparation components, active severe systemic sepsis, malignant disease progression out of control, pregnant patients |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Cryopreserved cell products stored in liquid nitrogen vapor phase ≤ -150°C before administration |
| Manufacturer | BoShengZhuoYue Biotechnology, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | S20250001 |
| Approval Date | Feb 26, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Body weight-based individualized cell dose.
Time: Infusion scheduled after complete cell thawing and preparation.
Instructions for use: Thaw cryopreserved cells strictly per protocol, administer as single or repeated intravenous infusion.
Interaction: Concurrent high-dose immunosuppressants enhance infection risk; live vaccines are contraindicated during treatment.
Side effects: Transient fever, chills, infusion reactions, increased risk of secondary infection, headache.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is the clinical indication of Amimestrocel Injection?
It treats steroid-refractory acute graft-versus-host disease mainly involving the digestive tract in patients over 14 years old.
What drug class does Amimestrocel Injectionl belong to?
It is an allogeneic mesenchymal stem cell therapy product with immunomodulatory and tissue repair functions.
What is the core mechanism of Amimestrocel Injection?
It suppresses excessive immune inflammation and repairs damaged gastrointestinal mucosal tissue caused by acute GVHD.
What are the common adverse reactions of Amimestrocel Injection?
Common reactions include transient fever, chills, infusion reactions and increased secondary infection risk.
RuiBoSheng® | Amimestrocel Injection | Acute Graft-Versus-Host Disease | DengYueRX
INN: Amimestrocel Injection
Indications: Acute graft-versus-host disease
Dosage Form: Injection
Strength: 12ml: 6.0 × 10 ^ 7 cells/bag
