TABLE 1.
List of approved cell therapy medicinal products (CTMPs).
| No. | Trade name/proper name | Manufacturer | Indication | Approved by/date | Product dosage | Product form | Product description | AT/AL | Price |
| 1 | Hemacord (Food and Drug Administration, 2019g) HPC, cord blood | New York Blood Center, Inc. (United States) | HSCT | US FDA 2011 November | A minimum of 5 × 108 total nucleated cells with at least 1.25 × 106 viable CD34 + cells at the time of cryopreservation | Bag | Human cord blood-derived HPCs | AL | NA/Generally, an average allogeneic HSCT costs US $200,000 |
| 2 | HPC, cord blood (Food and Drug Administration, 2019f) | Clinimmune Labs, UCCBB (United States) | HSCT | US FDA 2012 May | A minimum dose of 2.5 × 107 nucleated cells/kg at cryopreservation | Bag | Human cord blood-derived HPCs | AL | |
| 3 | Ducord HPC, cord blood (Food and Drug Administration, 2019e) | Duke University School of Medicine (United States) | HSCT | US FDA 2012 October | A minimum dose of 2.5 × 107 nucleated cells/kg at cryopreservation | Bag | Human cord blood- derived HPCs | AL | |
| 4 | Allocord HPC, cord blood (Yeh et al., 2018; Food and Drug Administration, 2019h) | SSM Health Cardinal Glennon Children’s Hospital (United States) | HSCT | US FDA 2013 May | A minimum of 5 × 108 TNC with at least 1.25 × 106 viable CD34 + cells at cryopreservation | Bag | Human cord blood- derived HPCs | AL | |
| 5 | HPC, cord blood (RxList, 2018) | LifeSouth Community Blood Centers, Inc. (United States) | HSCT | US FDA 2013 June | 2.5 × 107 nucleated cells/kg | Bag | Human cord blood- derived HPCs | AL | |
| 6 | HPC, cord blood (Food and Drug Administration, 2019c) | Bloodworks (United States) | HSCT | US FDA 2016 January | Minimum dose of 2.5 × 107 nucleated cells/kg at cryopreservation Each bag: 5 × 108 TNC with a minimum of 1.25 × 106 CD34 + cells in 25 ml | Bag | Human cord blood- derived HPCs | AL | |
| 7 | Celevecord HPC, cord blood (Food and Drug Administration, 2019d) | Cleveland Cord Blood Center (United States) | HSCT | US FDA 2016 September | A minimum dose of 2.5 × 107 nucleated cells/kg at cryopreservation | Bag | Human cord blood- derived HPCs | AL | |
| 8 | HPC, cord blood (Food and Drug Administration, 2019b) | MD Anderson Cord Blood Bank (United States) | HSCT | US FDA 2018 June | 2.5 × 107 nucleated cells/kg | Bag | Human cord blood- derived HPCs | AL | |
| 9 | Azficel-T laViv (Fibrocell Science Inc., 2013; S-Biomedics Ltd., 2019a) | Fibrocell Technologies, Inc. (United States) | Moderate to severe NLF wrinkles | US FDA 2011 June | ∼18 × 106 autologous fibroblasts in 1.2 ml suspension/three treatment sessions spaced at intervals of 3 to 6 weeks | Vial | Human fibroblasts | AT | $19,900 for a patient’s full course of treatment |
| 10 | Provenge Sipuleucel-T (Timmerman, 2010; Food and Drug Administration, 2019j) | Dendreon, Corp. (United States) | Asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) PCA | US FDA 2010 April | Minimum of 50 million activated CD54 + cells, suspended in 250 mL of Lactated Ringer’s solution | Bag | PBMNCs (primarily DCs) activated with PAP and GM-CSF | AT | $93,000 for 3 infusions |
| EMA 2010 September | |||||||||
| 11 | Prochymal BM-MSCs (Rattue, 2012; Mills, 2019) | Mesoblast, Ltd., International (Australia) | Acute and refractory GvHD | US FDA 2015 June | Intravenous administration: Low (2 million cells/kg) High (8 million cells/kg) | Bag | Human BM-MSCs | AL | $200,000 per treatment |
| Health Canada 2012 May | |||||||||
| 12 | Alofisell (Cx601) Darvadstrocel (Cho et al., 2015; NICE, 2019; Specialist pharmecy service, 2020) | TiGenix (United States) and Takeda (United Kingdom) | Complex perianal fistulas in CD | EMA 2018 March | 5 million MSCs/ml suspension Treatment: 4 vials | Vial | Human adipose tissue- derived MSCs | AL | ∼ $47,485 per treatment |
| 13 | KeraHeal (Biosolution Ltd., 2019a, b; Medical observer, 2019) | Biosolution, Co., Ltd. (South Korea) | Deep 2nd degree burn (> 30% of the TBSA) and 3rd degree burn (>10% of the TBSA) | South Korea MFDS 2006 May | 1 ml skin-derived keratinocytes suspension/100–400 cm2 | Vial | Human skin-derived keratinocytes | AT | ∼ $3,561/100–400 cm2 per vial |
| 14 | Queencell (Anterogen Co., 2020; Ministry of Food and Drug Safety, 2020) | Anterogen (South Korea) | Subcutaneous tissue defects | South Korea MFDS 2010 March | Minimally manipulated ADC ≥1.0 × 106/vial (1 mL). Cell volume: according to size of the subcutaneous fat defect site. | Vial | Human adipose tissue-derived adipose cell | AT | NA |
| 15 | CureSkin (Sang-jun, 2010; Biomedic, 2019; S-Biomedics Ltd., 2019b) | S. Biomedics (South Korea) | Depressed acne scars | South Korea MFDS 2010 May | 50 to 100 μl (2.0 × 107 cells/ml) of dermal fibroblasts per intradermal injection three times biweekly injection | Vial | Human dermal fibroblasts | AT | A 500-won coin-sized scar: ∼ $6,300 and the whole face: $11,700 |
| 16 | KeraHeal-Allo (Joo-sung, 2016; Biosolution Ltd., 2019c) | Biosolution, Co., Ltd. (South Korea) | Deep 2nd degree burns | South Korea MFDS 2015 October | One syringe (2.0 × 107 skin-derived keratinocytes/1.5 ml) to the image area of 100 cm2 | Pre-filled syringe | Human skin-derived keratinocytes suspended in a thermosensitive hydrogel | AL | ∼ $628 per 1.5-ml |
| 17 | Rosmir (Doo-hyun, 2018; Tego Science, 2020a, b) | Tego Sciences (South Korea) | Nasojugal groove | South Korea MFDS 2017 December | 2 × 107 fibroblasts cells per packaging unit; single intradermal administration | Vial | Human fibroblasts | AT | More than ∼ $ 81.38 per injection |
| 18 | Chondron (Naver, 2019; Sewon Cellontech Ltd., 2019a) | Sewon Cellontech, Corp. (South Korea) | Focal knee cartilage defect | South Korea MFDS 2001 January | 1 to 6 vials per patient >12 million cultured chondrocytes per vial | Vial | Human chondrocytes | AT | ∼$5,890 per treatment |
| 19 | RMS- Ossron (Sewon Cellontech Ltd., 2019b) | Sewon Cellontech, Co., Ltd. (South Korea) | Bone defects | South Korea MFDS 2009 August | 1 to 6 vials containing > 12 million cultured osteoblasts per vial (0.4 ml) | Vial | Human osteoblasts | AT | NA |
| 20 | Cartistem (Cade Hildreth, 2018; Medipost, 2019; SCT, 2019) | Medipost (South Korea) | Knee osteoarthritis (ICRS grade IV) | South Korea MFDS 2012 January | 500 μL/cm2 depending on the lesion (7.5 × 106 cells in 1.5 ml) | Vial | Human umbilical cord blood-derived MSCs | AL | $19,000–21,000 for the standard treatment and an additional $10,000 for each extra treatment |
| 21 | CreaVax-RCC (Woo, 2007; Ministry of Food and Drug Safety, 2019a) | JW CreaGene (South Korea) | Metastatic renal cell carcinoma for which nephrectomy can be performed | South Korea MFDS 2007 May | 8 doses (4 times, once every 2 weeks); each vial: 5.0 × 107 dendritic cells in 2 ml | Vial | Human DCs | AT | ∼ $27,000 (eight treatments) |
| 22 | Immuncell-LC (Sun-kyu, 2016; Ministry of Food and Drug Safety, 2019b) | Green Cross Cell, Corp. (South Korea) | Post-surgical recurrence of hepatocellular carcinoma | South Korea MFDS 2007 August | Each administration: 200 ml over a spot that contains 1.0 × 109 ∼ 2.0 × 1010 activated T-cells (16 doses) | Bag | Human activated T lymphocytes | AT | >$4,500 per dose |
| 23 | Cupistem (Cade Hildreth, 2018; Anterogen Co., 2019; Ministry of Food and Drug Safety, 2019c) | Anterogen (South Korea) | Crohn’s fistula | South Korea MFDS 2012 January | Fistula diameter: (a) ≤ 1 cm (3.0 × 107 AT-MSCs in 1 ml) (b) 1 < X < 2 cm (6.0 × 107 AT-MSCs in 2 ml) | Vial | Human adipose tissue-derived MSCs | AT | $3,000–5,000 per treatment |
| 24 | Cellgram-AMI (Doo-hyun, 2019) | FCB Pharmicell (South Korea) | AMI | South Korea MFDS 2011 July | (a) Under 60 kg = 10 mL/5.0 × 107 BM-MSCs (b) 61 ∼ 80 kg = 14 mL/7.0 × 107 BM-MSCs c. Over 81 kg = 18 mL/9 × 107 BM-MSCs | Pre-filled syringe | Human BM- MSCs | AT | $15,000 for one shot |
| 25 | Neuronata-R (Han-soo, 2018; Corestem Inc., 2019) | Corestem (South Korea) | ALS (Lou Gehrig’s Disease) | South Korea MFDS 2014 July | (0.1 ml/kg) 1.0 × 106 BM-MSCs in 4 ml self-cerebrospinal fluid Twice every 4 weeks | Pre-filled syringe | Human BM-MSCs | AT | ∼$55,000 annually (24 treatments) |
| 26 | Cartigrow (Das, 2018; FAQ, 2019) | Regrow Biosciences, Pvt. Ltd. (India) | Knee/ankle cartilage loss | India DCGI 2017 April | 48 million chondrocytes | Vial | Human chondrocytes | AT | $1,988 per treatment |
| 27 | Ossgrow (Das, 2018; Regrow Biosciences Pvt. Ltd., 2019) | Regrow Biosciences, Pvt. Ltd. (India) | Early-stage AVN of hip | India DCGI 2017 April | 1.2 × 107 autologous bone cells/0.4 ml | Vial | Human osteoblasts | AT | $1,988 per treatment |
| 28 | Apceden AMDDC (Apac Biotech, 2019; Safer, 2019) | APAC Biotech (India) | Prostate, ovarian, colorectal and NSCLC | India DCGI 2017 March | 6 doses (4–5 million mature DCs per dose) in 14 weeks | Vial | Monocyte-derived mature DCs | AT | $7,100–9,940 per treatment |
| 29 | Stempeucel (Jayaraman, 2016; Stempeutics Research Pvt Ltd., 2019) | Stempeutics Research (India) | CLI due to thromboangiitis obliterans (Buerger’s disease) | India DCGI 2016 May | Intramuscular injection of 1 or 2 million cells/kg body weight | Vial | Human BM-MSCs | AL | $2200 per treatment |
| 30 | Chondrocytes-T-Ortho-ACI Cartogen (Orthocell, 2018, 2019) | Orthocell (Australia) | Cartilage damage (chondromalacia patella or OCD) 18–55 years | Australia TGA 2017 March | 2–5 million cells suspended in 1.0 ml of assembly medium | Bag | Human chondrocytes | AT | $4,500 per treatment |
| 31 | Temcell HS (StreetInsider, 2015; Jcr Pharmaceuticals Co., 2020) | JCR Pharmaceuticals (Japan) | Acute and refractory GvHD | Japan PMDA 2015 September | Intravenous infusion of 2 million cells/kg (each bag contains 72 million cells in 18 ml of saline) 4 ml per minute twice weekly at an interval of 3 days or more for 4 weeks | Bag | Human BM-MSCs | AL | $7,600 per bag |
| 32 | RenuDermcell (CellTech, 2019) | Cell Tech Pharmed (Iran) | Facial wrinkles and acne scars, atrophic skin lesions following skin trauma | Iran FDA 2018 January | Intradermal injection of a minimum of 3.0 × 107 cells. Usually three repeated times | Vial | Human dermal fibroblasts | AT | NA |
| 33 | MesestroCell (CellTech, 2019) | Cell Tech Pharmed (Iran) | OA and knee joint arthritis | Iran FDA 2018 January | A minimum intra-articular injection of 2.0 × 107 cells/knee, totally 4.0 × 107 cells for both knees | Vial | BM-MSCs | AT | NA |
| 34 | RecolorCell (CellTech, 2019) | Cell Tech Pharmed (Iran) | Different types of vitiligo: focal; segmental generalized | Iran FDA 2019 February | Approximately 70,000 cells/cm2 area of vitiligo patches; This product is effective for vitiligo patches < 200 cm2 | Vial | Human keratinocytes and melanocytes | AT | NA |
ADC, adipose tissue-derived cell; AL, allogeneic; ALS, amyotrophic lateral sclerosis; AMDDC, autologous monocyte-derived mature dendritic cell; AMI, acute myocardial infarction; AT, autologous; AT-MSCs, adipose tissue-derived mesenchymal stem cell; AVN, avascular necrosis; BM-MSC, bone marrow-derived mesenchymal stem cell; CD, Crohn’s disease; CLI, critical limb ischemia; DC, dendritic cell; DCGI, Drug Controller General of India; DFU, diabetic foot ulcer; EMA, European Medicines Agency; FDA, Food and Drug Administration; GM-CSF, granulocyte macrophage colony stimulating factor; GvHD, graft-versus-host disease; HCEpC, human corneal epithelial cell; HPC, hematopoietic progenitor cell; HSCT, hematopoietic stem cell transplantation; ICRS, International Cartilage Repair Society; MFDS, Ministry of Food and Drug Safety; MSC, mesenchymal stem cell; NA, not available; NLF, nasolabial fold NSCLC, non-small cell lung carcinoma; OA, osteoarthritis; OCD, osteochondritis dissecans; PAP, prostatic acid phosphatase; Pca, prostate cancer; PBMNC, peripheral-blood mononuclear cell; PMDA, Pharmaceuticals and Medical Devices Agency; TBSA, total body surface area; TGA, Therapeutic Goods Administration; TNC, total nucleated cell; UCCBB, University of Colorado Cord Blood Bank. All prices are in USD.