Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World
Abstract
:1. Introduction
- Cell therapy medicinal products (CTMPs). These contain manipulated cells or tissues that are intended to be used for different essential functions in the recipient, compared to the one that they had in the donor.
- Tissue-engineered products (TEPs). Engineered cells or tissues that can regenerate, repair, or replace human tissue.
- Gene therapy medicinal products (GTMPs). Related to diagnostic, therapeutic, or prophylactic effects that use specific recombinant nucleic acids.
- Combined ATMPs (cATMPs). These integrate two or more of the products listed above [1].
2. Mesenchymal Stem Cells
3. Clinical Applications of MSCs
4. Agency-Approved MSC Therapies
Name/Year | Company | Origin | Use | Description | Dosage | AT/AL | Charge |
---|---|---|---|---|---|---|---|
Queen-cell/2010 [1,27] | Anterogen (Republic of Korea) | Republic of Korea MFDS | Connective tissue disorders | A heterogeneous mixture of AT-MSCs and other cell types such as pre-adipocytes, endothelial progenitor cells, pericytes, mast cells, and fibroblasts | 1 × 10⁶ cells/mL | AT | NA |
Cellgram AMI/2011 [1,28] | Pharmicell (Republic of Korea) | Republic of Korea MFDS | AMI | Human BM-MSCs | a. Under 60 kg = 10 mL/5.0 × 10⁷ BM-MSCs b. 61–80 kg = 14 mL/7.0 × 10⁷ BM-MSCs c. >80 kg = 18 mL/9 × 10⁷ BM-MSCs | AT | USD 15,000 per shot |
Cupistem/2012 [1,27,38] | Anterogen (Republic of Korea) | Republic of Korea MFDS | Crohn’s fistula | Human-adipose-tissue-derived MSCs | Fistula diameter: (a) ≤1 cm (3 × 10⁷ MSCs in 1 mL) (b) 1 < X< 2 cm (6 × 10⁷ MSCs in 2 mL) | AT | USD 5000 per treatment |
Cartistem/2012 [1,29] | Medipost (Republic of Korea) | Republic of Korea MFDS | Knee OA (ICRS grade IV) | Human-umbilical-cord-blood-derived MSCs | 7.5 × 10⁶ cells/vial (depending on the size of the lesion) | AL | USD 21,000 per treatment |
NeuroNataR/2014 [1,30,39] | Corestem (Republic of Korea) | Republic of Korea MFDS | ALS | Human BM-MSCs | 1 × 10⁶ BM-MSCs/kg Twice every 4 weeks | AT | USD 55,000 annually |
Holoclar/2015 [35,40] | Chiesi Farmaceutici | EMA | Limbal stem cell deficiency due to ocular burns | Limbal stem cells | 79,000–316,000 cells/cm² | AT | USD 80,000 per eye |
Reme-stemcel-L/2015 [1,5,8] | Mesoblast, Ltd. (Australia) | US FDA | Acute and refractory GvHD for pediatric patients | Human BM-MSCs | IV administration: Low (2 million cells/kg) High (8 million cells/kg) | AL | USD 200,000 per treatment |
Temcell HS/2015 [1,31,41] | JCR Pharmaceuticals (Japan) | Japan PMDA | Acute and refractory GvHD | Human BM-MSCs | IV infusion of 2 million cells/kg (each bag contains 72 million cells in 18 mL of saline); 4 mL per minute twice weekly in intervals of 3 days or more for 4 weeks | AL | USD 7600 per bag |
Stem-peucel/2016 [1,33] | Stem-peutics Research Bangalore (India) | India DCGI | CLI | Human BM-MSCs | Intramuscular injection of 1 or 2 million cells/kg body | AL | USD 2200 per treatment |
Alofisel/2018 [1,36,42] | TiGenix (US) and Takeda (UK) | EMA | Complex perianal fistulas in CD | Human-adipose-tissue-derived MSCs | Vial: 30 million MSCs/6 mL Treatment: 4 vials | AL | USD 47,485 per treatment |
Mesestro-Cell/2018 [1,34] | Cell Tech Pharmed (Iran) | Iran FDA | OA | BM-MSCs | A minimum intra-articular injection of 2 × 10⁷ cells/knee; in total, 4 × 10⁷ cells for both knees | AT | NA |
Stemirac/2018 [32,43] | Nipro Corp | Japan PMDA | Spinal cord injury | BM-MSCs | 50 to 200 million cells | AT | USD 135,000 |
5. Current Issues and Future Directions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Fernández-Garza, L.E.; Barrera-Barrera, S.A.; Barrera-Saldaña, H.A. Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World. Pharmaceuticals 2023, 16, 1334. https://doi.org/10.3390/ph16091334
Fernández-Garza LE, Barrera-Barrera SA, Barrera-Saldaña HA. Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World. Pharmaceuticals. 2023; 16(9):1334. https://doi.org/10.3390/ph16091334
Chicago/Turabian StyleFernández-Garza, Luis E., Silvia A. Barrera-Barrera, and Hugo A. Barrera-Saldaña. 2023. "Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World" Pharmaceuticals 16, no. 9: 1334. https://doi.org/10.3390/ph16091334
APA StyleFernández-Garza, L. E., Barrera-Barrera, S. A., & Barrera-Saldaña, H. A. (2023). Mesenchymal Stem Cell Therapies Approved by Regulatory Agencies around the World. Pharmaceuticals, 16(9), 1334. https://doi.org/10.3390/ph16091334