EMA Unveils 19 Advanced Therapy Product Classifications
Posted 12 April 2016 | By Michael Mezher
The European Medicines Agency (EMA) on Tuesday released a host of classification decisions for advanced therapies being developed to treat various types of tissue damage, including burns, scars and non-healing wounds.
The agency, through its Committee for Advanced Therapies (CAT), offers sponsors an optional consultation to determine whether a product meets the criteria for an advanced-therapy medicinal product (ATMP). The classification procedure is laid out in Article 17 of Regulation (EC) No 1394/2007, which states:
"Any applicant developing a product based on genes, cells or tissues may request a scientific recommendation of the Agency with a view to determining whether the referred product falls, on scientific grounds, within the definition of an advanced therapy medicinal product," the regulation says.
The procedure is intended to help sponsors when their product borders between different classifications, such as a product that combines a tissue-based product and a medical device.
Once EMA has consulted with the European Commission for a decision under this procedure, the agency publishes its decision after removing or redacting any proprietary or confidential information.
Due to the complex and novel nature of ATMPs, they are required to be submitted via the centralised procedure and cannot be approved directly by a national regulatory authority.
In total, the agency issued 19 classification decisions, 17 of which were classified as tissue engineered products, and one that was classified as a somatic cell therapy. The one product that did not meet the criteria for an ATMP was a decellularized matrix made from pig skin, which EMA said did not contain viable tissue or cells and is not a gene therapy.
| Active Substance(s) | Finished Product | Indication | EMA/CAT Conclusion |
|---|
| Transgenic porcine acellular dermal matrix | Decellularized porcine dermal matrix | Treatment of various skin injuries | Does not meet definition of ATMP |
| Adipose-derived mesenchymal stem cells | Ex vivo expanded adipose-derived stem cell suspension in a pre-filled syringe for autologous application | Autoimmune diseases (rheumatoid arthritis and systemic lupus erythematosus) | Somatic Cell Therapy |
| Human amniotic membrane mesenchymal stem cells (hAMMSCs) | Human amniotic membrane mesenchymal stem cells seeded on acellular amniotic matrix | Treatment of burns, scars, non-healing wounds | Tissue Engineered Product |
| Human amniotic membrane mesenchymal stem cells as a sheet | Treatment of burns, scars, non-healing wounds | Tissue Engineered Product |
| Human amniotic membrane mesenchymal stem cells seeded on acellular dermal matrix | Treatment of burns, scars, non-healing wounds | Tissue Engineered Product |
| Human amniotic membrane mesenchymal stem cells in suspension | Treatment of burns, scars, non-healing wounds | Tissue Engineered Product |
| MSCs derived from human burn eschar and debrided adipose tissue cells and keratinocytes | MSCs isolated from human burn eschar and debrided adipose tissue cells, keratinocytes isolated from skin of living donor seeded onto acellular dermal matrix | Treatment of deep and extensive burns, chronic wounds and skin donor sites | Tissue Engineered Product |
| MSCs derived from human burn eschar and debrided adipose tissue cells and keratinocytes (Separate Decision) | MSCs isolated from human burn eschar and debrided adipose tissue cells, keratinocytes isolated from skin of living donor seeded onto acellular amniotic matrix | Treatment of deep and extensive burns, chronic wounds and skin donor sites | Tissue Engineered Product |
| Human amniotic membrane mesenchymal stem cells (hAMMSCs), allogeneic or autologous keratinocytes, co-cultured | Co-culture of keratinocytes and hAMMSCs as seeded on acellular amniotic matrix | Treatment of burns, non-healing wounds | Tissue Engineered Product |
| Co-culture of keratinocytes and hAMMSCs as seeded on acellular amniotic matrix | Treatment of burns, non-healing wounds | Tissue Engineered Product |
| Cultured epithelial autografts (CEA); cultured fibroblasts | Cells seeded on acellular amniotic matrix | Treatment of deep and extensive burns, chronic wounds, skin donor sites | Tissue Engineered Product |
| Cells seeded on acellular dermal matrix | Treatment of deep and extensive burns, chronic wounds, skin donor sites | Tissue Engineered Product |
| Cells seeded on transgenic porcine acellular dermal matrix | Treatment of deep and extensive burns, chronic wounds, skin donor sites | Tissue Engineered Product |
| Mesenchymal stem cells isolated from umbilical cord | Mesenchymal stem cells isolated from umbilical cord suspended in autologous platelet rich plasma | Burns, non-healing wounds | Tissue Engineered Product |
| Mesenchymal stem cells isolated from umbilical cord as a sheet | Burns, non-healing wounds | Tissue Engineered Product |
| Mesenchymal stem cells isolated from umbilical cord seeded onto acellular dermal matrix | Burns, non-healing wounds | Tissue Engineered Product |
| Mesenchymal stem cells isolated from umbilical cord seeded acellular amniotic matrix | Burns, non-healing wounds | Tissue Engineered Product |
| Allogeneic human keratinocytes and human umbilical cord mesenchymal stem cells | Cells seeded on acellular amniotic matrix | Treatment of burns and non-healing wounds | Tissue Engineered Product |
| Cells seeded on acellular dermal matrix | Treatment of burns and non-healing wounds | Tissue Engineered Product |
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