In my opinion there are a couple surprises. I'm surprised at the non-cardiac cells (MNCs, CD133s, and MSCs) for cardiac disease/repair being designated TEPs. I'm also surprised at the islets not being classified as an ATMP.
I've tapped into my European and/or regulatory colleagues to help explain those two as well as help us draw any other conclusions or observations we can make in terms of how the CAT is thinking based on the compendium of classifications we have to-date. I'll post an update here when I have something useful.
In January, the following product was classified as a tissue engineered product - not combined:
- Layer of autologous corneal epithelium containing stem cells intended for the treatment of extended corneal lesions
In April, the following product was classified as a tissue engineered product, combined:
- Allogeneic human fibroblasts cultured onto a biodegradable matrix, intended for use of conditions in the therapeutic area of dermatology
In May, the following product was classified as a somatic cell therapy medicinal product:
- Heterologous human adult liver-derived progenitor cells, intended for the treatment of inborn errors of liver metabolis
In July, the following product was classified as a Tissue Engineered Product, non-combined:
- Suspension of allogeneic bone-marrow derived osteoblastic cells, intended for the treatment of non-union, delayed union or other fractures.
In September, the following product was classified as a Tissue Engineered Product, non-combined:
- Autologous mesenchymal stem cells (MSC), intended for the treatment of chronic heart failure symptoms by improvement in exercise capacity of NYHA class II and III chronic heart failure patients receiving standard therapy
- Human islets of Langerhans, intended for: Post pancreatectomy for benign pancreatic pathologies (autologous); Treatment of severe forms of type 1 diabetes (Allogeneic)
In October, the following product was classified as a somatic cell therapy medicinal product:
- Autologous dendritic cell (DCs) immunotherapy consisting of autologous mature DCs coelectroporated with autologous RCC IVT RNA and synthetic CD40L IVT RNA, intended for the treatment of patients with advanced renal cell carcinoma
In November, the following products were classified as tissue-engineered products:
- Concentrate of autologous bone marrow mononuclear cells (MNC), intended for improvement of heart function and quality of life in patients with chronic ischaemic heart disease and after MI.
- CD 133+ Autologous bone marrow derived stem cells, intended for Improvement of heart function (LVEF) and quality of life in patients with chronic ischemic heart disease and after MI
In December, the following product was classified as somatic cell therapy medicinal product:
- Autologous CD4+ T cells targeted to cells presenting class II restricted epitopes, intended forthe treatment of autoimmune diseases with MHC restricted specific immunity e.g. multiple sclerosis, type I diabetes or graft rejection.