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