Table 1.

Overview of authorized regenerative medicine products—a list of allowed cellular, tissue-based, and gene therapy products in the EU, USA, and Japan.

Product name	Manufacturer	Description	Indication of approval
Imlygic	Amgen Inc.	Gene therapy medicinal product	Unrespectable metastatic melanoma		×	×
Glybera	UniQure Biopharma B.V.	Gene therapy medicinal product	Lipoprotein lipase deficiency with severe pancreatitis		×
TheraCys	Sanofi Pasteur Limited	Attenuated mycobacteria	Carcinoma in situ of the urinary bladder and Ta and/or T1 papillary tumours			×
GINTUIT	Organogenesis Incorporated	Allogeneic keratinocytes and fibroblasts in bovine collagen	Mucogingival conditions			×
TEMCELL	JCR Pharmaceuticals	Allogeneic mesenchymal stromal cells	Acute graft versus host disease	×
Holoclar	Chiesi Farmaceutici S.p.A.	Autologous corneal epithelial (including stem cells)	Limbal stem cell deficiency with burned corneal damage		×
PROVENGE	Dendreon Corporation	Activated autologous peripheral blood mononuclear cells	Prostate cancer		×	×
HeartSheet	Terumo	Autologous skeletal myoblast sheet	Chronic ischaemic heart disease	×
JACE	Japan Tissue Engineering Co. Ltd	Autologous cultured keratinocytes sheet	Full-thickness skin burn wounds	×
Laviv	Fibrocell Technologies, Inc.	Autologous fibroblast	Nasolabial fold wrinkles			×
JACC	Japan Tissue Engineering Co. Ltd	Autologous cultured chondrocytes in atelocollagen gel	Traumatic cartilage defects and osteochondritis dissecans	×
Carticel	Genzyme Biosurgery	Autologous chondrocytes	Acute symptomatic femoral condyle cartilage defects			×
ChondroCelect	TiGenix N.V.	Autologous cartilage cells	Single-defect symptomatic cartilaginous femoral condyle defects		×
Maci	Aastrom Biosciences	Autologous chondrocytes	Full-thickness symptomatic cartilage defects		×
N/A	Bloodworks	CBdHPC	Hematopoietic system deficiency			×
N/A	LifeSouth Community Blood Centers Inc.	CBdHPC	Hematopoietic system deficiency			×
N/A	Clinimmune Labs, University of Colorado Cord Blood Bank	CBdHPC	Hematopoietic system deficiency			×
Ducord	Duke University School of Medicine	CBdHPC	Hematopoietic system deficiency			×
Hemacord	New York Blood Center, Inc	CBdHPC	Hematopoietic system deficiency			×
ALLOCORD	SSM Cardinal Glennon Children's Medical Center	CBdHPC	Hematopoietic system deficiency			×

Marking under the flags indicate approval in corresponding territories.

CBdHPC = cord blood-derived hematopoietic progenitor cells; N/A = not-applicable.