CAR-T Cell Therapy for Leukemia
Chimeric antigen receptor T-cell (CAR-T) therapy consists of patient-derived T-cells genetically modified to target CD19-positive cancer cells, used in treating relapsed B-cell acute lymphoblastic leukemia. Classified under HTS 3002.51.00.00 as cell therapy products, these are cell cultures modified via biotechnological processes for therapeutic use. They are administered intravenously after expansion and infusion preparation.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If unmodified primary cell cultures without therapeutic modification
Unmodified antisera, blood fractions, or basic cell cultures fall under vaccines/toxins rather than specifically modified cell therapy products.
If for diagnostic rather than therapeutic cell cultures
Cell cultures intended solely for lab diagnostic testing shift to other immunological products, excluding therapy applications.
If sold as research-grade biotech reagents not for human therapy
Diagnostic reagents or lab preparations outside therapeutic use are classified in Chapter 38 for chemical products.
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Import Tips & Compliance
• Obtain FDA Biologics License Application (BLA) approval and IND documentation prior to import; cell therapies require pre-approval
• Maintain ultra-low temperature cold chain (-150°C or cryopreserved) with validated shipping containers to preserve cell viability
• Avoid misclassification as general immunological products; provide biotech modification certificates to confirm cell therapy status
Related Products under HTS 3002.51.00.00
NK Cell Therapy for Solid Tumors
Natural killer (NK) cells from peripheral blood, cytokine-activated and expanded for adoptive transfer in treating melanoma and other solid tumors. As modified cell cultures for cancer immunotherapy, they classify under HTS 3002.51.00.00 cell therapy products. These cells directly lyse tumor targets without prior sensitization.
Mesenchymal Stem Cell Therapy for Osteoarthritis
Allogeneic mesenchymal stem cells (MSCs) derived from umbilical cord tissue, expanded and cryopreserved for intra-articular injection to reduce inflammation in knee osteoarthritis. Falls under HTS 3002.51.00.00 as cell therapy products due to their modified cell culture status for regenerative therapeutic purposes. These biologics promote cartilage repair via immunomodulatory effects.
Treg Cell Therapy for Autoimmune Diseases
Regulatory T-cells (Tregs) expanded ex vivo from patient blood, modified for enhanced suppressive function, used in treating graft-versus-host disease post-transplant. HTS 3002.51.00.00 covers these as cell therapy products—biotechnologically modified cell cultures for immunotherapy. They restore immune tolerance by suppressing overactive responses.
iPSC-Derived Cardiomyocyte Therapy for Heart Failure
Induced pluripotent stem cell (iPSC)-derived cardiomyocytes for intramyocardial injection to repair damaged heart tissue post-myocardial infarction. These engineered cell cultures are cell therapy products under HTS 3002.51.00.00, modified biotechnologically for cardiac regeneration. They integrate and beat synchronously with host tissue.
Dendritic Cell Vaccine for Prostate Cancer
Autologous dendritic cells loaded with tumor-associated antigens (e.g., Provenge/sipuleucel-T), matured ex vivo for personalized cancer vaccination. HTS 3002.51.00.00 applies to these as cell therapy products—modified cell cultures for active immunotherapy. They prime T-cell responses against prostate cancer cells.