Review Article

Bottlenecks in the Efficient Use of Advanced Therapy Medicinal Products Based on Mesenchymal Stromal Cells

Table 2

Advanced therapy medicinal products (ATMPs) with a valid marketing authorisation.

Trade nameCompanyAuthorised byCell type Indication

CarticelbGenzyme (Sanofi Biosurgery)FDA (1997)Autologous cultured chondrocytes For the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral, or trochlea) caused by acute or repetitive trauma in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure

ChondrondSewon Cellontech Co., Ltd.KFDA (2001)Autologous chondrocyte implantationArticular cartilage defects

ArticelldDuplogeneKFDA (2002)Autologous cultured chondrocytes Articular cartilage defects

HalodermdTego ScienceKFDA (2002)Cultured epidermal autograft Burn wounds

KalodermadTego ScienceKFDA (2005)Allogeneic keratinocyte sheetBurn wounds

JACEeJ-TEC (Japan Tissue Engineering Co., Ltd.)Japan’s Ministry of Health, Labour & Welfare (2007)Autologous cultured epidermisBurn wounds

ChondrocelectcTigenix, BelgiumEMA (2009)Autologous cultured chondrocytes In adults to repair damage to the cartilage in the knee

ProvengebDendreon CorporationFDA (2010) 
EMA (2013)
Autologous PB-MNS activated with FAP-GM-CSF (sipuleucel-T)In autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant (hormone refractory) prostate cancer

LaVivbFibrocell Technologies, Inc.FDA (2011)Autologous cultured fibroblasts (azficel-T)Indicated for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults

HemacordbNew York Blood Center, Inc.FDA (2011)Allogeneic HPC, cord bloodFor use in unrelated donor haematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for haematopoietic and immunological reconstitution in patients with disorders affecting the haematopoietic system that are inherited or acquired or that result from myeloablative treatment

GlyberaaUniQure Biopharma B.V., NetherlandsEMA (2012)Alipogene tiparvovecTo treat adults with lipoprotein lipase deficiency who have severe or multiple attacks of pancreatitis (inflammation of the pancreas) despite maintaining a low-fat diet

GintuitcOrganogenesis IncorporatedFDA (2012)Allogeneic cultured keratinocytes and fibroblasts in bovine collagen Allogeneic cellularized scaffold product indicated for topical (nonsubmerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults

DucordbDuke University School of MedicineFDA (2012)Allogeneic HPC, cord bloodFor use in unrelated donor haematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for haematopoietic and immunological reconstitution in patients with disorders affecting the haematopoietic system that are inherited or acquired or that result from myeloablative treatment

JACCeJ-TEC (Japan Tissue Engineering Co., Ltd.)Japan’s Ministry of Health, Labour & Welfare (2012)Autologous cultured cartilageArticular cartilage defects

MACIcGenzyme (Sanofi Biosurgery)EMA (2013)Matrix-induced autologous cultured chondrocytes For implant to repair cartilage defects at the ends of the bones of the knee joint

AllocordbSSM Cardinal Glennon Children’s Medical CenterFDA (2013)Allogeneic HPC, cord blood For use in unrelated donor haematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for haematopoietic and immunological reconstitution in patients with disorders affecting the haematopoietic system that are inherited or acquired or that result from myeloablative treatment

FAP-GM-CSF: prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor; HPC: haematopoietic progenitor cells; PB-MNS: peripheral blood mononuclear cells.
aGTMP: gene therapy medicinal product; bSCTMP: somatic cell therapy medicinal product; cTEMP: tissue-engineered medicinal product; dbiotechnology-based product (KFDA Classification); emedical devices (Japan Classification).