Mesenchymal stem cells are multipotent stem cells with the capacity for both self-renewal and differentiation. They can transform into various cell types, offering a wide range of clinical applications. MSCs are present in various sources, including the umbilical cord, dental pulp, adipose tissue (fat), and bone marrow.
MSCs operate through the secretion of bioactive factors and exosomes using the endocrine and paracrine systems. They release various molecules, including cytokines, growth factors, antioxidants, pro-angiogenic factors, and factors that stimulate cell proliferation and angiogenesis. These secretions mitigate stress responses and apoptosis in damaged cells, facilitating tissue repair. Additionally, MSCs play a role in the regulation of local and systemic inflammatory and immune responses, contributing to their therapeutic effects.
MSCs possess the capability to modulate a patient’s immune system, stimulate cell growth, and differentiate into diverse specialised cell types. Their potential applications have extended to a broad spectrum of diseases, including but not limited to heart disease, diabetes, Alzheimer’s disease, spinal cord injury, chronic trauma, Graft-versus-host disease, rheumatoid arthritis, liver cirrhosis, retinal diseases, and numerous others.
Research has indicated that replenishing an adequate quantity of stem cells within the body can trigger other endogenous stem cells found in the human body. This, in turn, enhances the metabolic functions of cells and organs, ultimately leading to a potential delay in the overall ageing process.
The potential benefits encompass a wide range of improvements, including increased energy and physical vitality, enhanced overall health, anti-ageing effects, heightened libido, restoration of hormonal balance, firmer and more youthful skin, and improvements in memory.
| Content Of Mesenchymal stem cells per 200 million [Nucleated cells] | |
|---|---|
| Cord Blood | 1 cell |
| Adult Bone Marrow | 2,000 cells |
| Wharton’s Jelly | 666,000 cells |
*Reference: BMC Cell Biology 2006,7: 14
Clinical research on MSCs is on the rise, with significant trends and observations. The worldwide landscape of MSC clinical studies is notable. China, Europe, and the United States are at the forefront of clinical research in this field, indicating its global importance and widespread interest.
MSCs hold promise for the treatment of a wide array of diseases. Clinical research encompasses hundreds of conditions, with particular emphasis on three primary areas: nervous system, cardiovascular, and orthopaedic diseases.
In addition to the core areas, clinical research on MSCs extends to various other diseases, including diabetes, liver disorders, lung diseases, gastrointestinal tract conditions, skin ailments, and Graft-versus-host disease (GvHD). This diversification underscores the versatility and potential of MSCs in addressing a wide range of medical challenges.
The data from Clinicaltrials.gov reflects the growing interest and investment in MSC research and its application in addressing diverse health issues. This suggests that MSCs will continue to play a pivotal role in future medical advancements, with an expanding range of therapeutic applications.
| No. | Product Name | Company | Approved Country | Regulator | Year | Indications | Product Type |
|---|---|---|---|---|---|---|---|
| 1 | Queencell | Anterogen Co., Ltd. | South Korea | MFDS (KFDA) | 2010 | Subcutaneous tissue defects | Autologous adipose tissue-derived MSC (AT-MSC) |
| 2 | Cellgram-AMI / Cellgram® | Pharmicell Co., Ltd. | South Korea | MFDS (KFDA) | 2011 | Acute myocardial infarction; improving heart function / LVEF in AMI patients | Autologous bone marrow-derived MSC (BM-MSC) |
| 3 | Cartistem® | Medipost Co., Ltd. | South Korea | MFDS (KFDA) | 2012 | Knee cartilage defects due to degenerative osteoarthritis or repeated trauma | Allogeneic umbilical cord blood-derived MSC (UCB-MSC) |
| 4 | Cupistem® | Anterogen Co., Ltd. | South Korea | MFDS (KFDA) | 2012 | Crohn’s fistula | Autologous adipose tissue-derived MSC / ASC (AT-MSC) |
| 5 | Prochymal® / Remestemcel-L | Osiris Therapeutics Inc. / Mesoblast Ltd. | Canada, New Zealand | Health Canada, Medsafe | 2012 | Steroid-refractory acute GvHD | Allogeneic bone marrow-derived MSC (BM-MSC) |
| 6 | Neuronata-R® | Corestem Inc. / CorestemChemon Inc. | South Korea | MFDS (KFDA) | 2014 | Amyotrophic lateral sclerosis (ALS) | Autologous bone marrow-derived MSC (BM-MSC) |
| 7 | Temcell® HS Inj. | JCR Pharmaceuticals | Japan | PMDA / MHLW | 2015 | Steroid-refractory acute GvHD | Allogeneic bone marrow-derived MSC (BM-MSC) |
| 8 | Holoclar® | Chiesi Farmaceutici | European Union | EMA | 2015 | Moderate to severe limbal stem cell deficiency caused by physical or chemical ocular burns | Autologous ex vivo expanded human corneal epithelial cells containing limbal stem cells |
| 9 | Astrostem | Nature Cell Co., Ltd. | Japan | MHLW | 2015 | Autoimmune disease | Allogeneic adipose-derived MSC (AD-MSC) |
| 10 | Stempeucel® | Stempeutics Research Pvt. Ltd. | India | CDSCO / DCGI | 2016 / 2020 | Critical limb ischemia, especially no-option CLI due to Buerger’s disease and atherosclerotic peripheral arterial disease | Allogeneic pooled bone marrow-derived MSC / mesenchymal stromal cells |
| 11 | Alofisel® (darvadstrocel) | TiGenix NV / Takeda | European Union, Japan | EMA; MHLW/PMDA | 2018 EU; 2021 Japan | Complex perianal fistulas in Crohn’s disease | Expanded allogeneic adipose-derived MSC (eASC) |
| 12 | Stemirac® | Nipro Corporation | Japan | PMDA / MHLW | 2018 | Spinal cord injury | Autologous bone marrow-derived MSC (BM-MSC) |
| 13 | MesestroCell / Mesestro-Cell | Cell Tech Pharmed (Iran) | Iran | Iran FDA | 2018 | Osteoarthritis | Autologous bone marrow-derived MSC (BM-MSC) |
| 14 | Ryoncil® (remestemcel-L-rknd) | Mesoblast Limited | United States | US FDA | 2024 | Steroid-refractory acute GvHD in paediatric patients 2 months and older | Allogeneic bone marrow-derived MSC / mesenchymal stromal cell therapy |
| 15 | Ruibosheng® (Amimestrocel Injection) | Platinumlife Biotechnology (Beijing) Co., Ltd. | China | NMPA | 2025 | Steroid-refractory acute GvHD with predominant gastrointestinal involvement in patients aged 14 years and older | Allogeneic human umbilical cord-derived MSC (hUC-MSC) |
| No. | Product Name |
|---|---|
| 1 | Queencell |
| 2 | Cellgram-AMI / Cellgram® |
| 3 | Cartistem® |
| 4 | Cupistem® |
| 5 | Prochymal® / Remestemcel-L |
| 6 | Neuronata-R® |
| 7 | Temcell® HS Inj. |
| 8 | Holoclar® |
| 9 | Astrostem |
| 10 | Stempeucel® |
| 11 | Alofisel® (darvadstrocel) |
| 12 | Stemirac® |
| 13 | MesestroCell / Mesestro-Cell |
| 14 | Ryoncil® (remestemcel-L-rknd) |
| 15 | Ruibosheng® (Amimestrocel Injection) |
| Company | Approved Country | Regulator | Year | Indications | Product Type |
|---|---|---|---|---|---|
| Anterogen Co., Ltd. | South Korea | MFDS (KFDA) | 2010 | Subcutaneous tissue defects | Autologous adipose tissue-derived MSC (AT-MSC) |
| Pharmicell Co., Ltd. | South Korea | MFDS (KFDA) | 2011 | Acute myocardial infarction; improving heart function / LVEF in AMI patients | Autologous bone marrow-derived MSC (BM-MSC) |
| Medipost Co., Ltd. | South Korea | MFDS (KFDA) | 2012 | Knee cartilage defects due to degenerative osteoarthritis or repeated trauma | Allogeneic umbilical cord blood-derived MSC (UCB-MSC) |
| Anterogen Co., Ltd. | South Korea | MFDS (KFDA) | 2012 | Crohn’s fistula | Autologous adipose tissue-derived MSC / ASC (AT-MSC) |
| Osiris Therapeutics Inc. / Mesoblast Ltd. | Canada, New Zealand | Health Canada, Medsafe | 2012 | Steroid-refractory acute GvHD | Allogeneic bone marrow-derived MSC (BM-MSC) |
| Corestem Inc. / CorestemChemon Inc. | South Korea | MFDS (KFDA) | 2014 | Amyotrophic lateral sclerosis (ALS) | Autologous bone marrow-derived MSC (BM-MSC) |
| JCR Pharmaceuticals | Japan | PMDA / MHLW | 2015 | Steroid-refractory acute GvHD | Allogeneic bone marrow-derived MSC (BM-MSC) |
| Chiesi Farmaceutici | European Union | EMA | 2015 | Moderate to severe limbal stem cell deficiency caused by physical or chemical ocular burns | Autologous ex vivo expanded human corneal epithelial cells containing limbal stem cells |
| Nature Cell Co., Ltd. | Japan | MHLW | 2015 | Autoimmune disease | Allogeneic adipose-derived MSC (AD-MSC) |
| Stempeutics Research Pvt. Ltd. | India | CDSCO / DCGI | 2016 / 2020 | Critical limb ischemia, especially no-option CLI due to Buerger’s disease and atherosclerotic peripheral arterial disease | Allogeneic pooled bone marrow-derived MSC / mesenchymal stromal cells |
| TiGenix NV / Takeda | European Union, Japan | EMA; MHLW/PMDA | 2018 EU; 2021 Japan | Complex perianal fistulas in Crohn’s disease | Expanded allogeneic adipose-derived MSC (eASC) |
| Nipro Corporation | Japan | PMDA / MHLW | 2018 | Spinal cord injury | Autologous bone marrow-derived MSC (BM-MSC) |
| Cell Tech Pharmed (Iran) | Iran | Iran FDA | 2018 | Osteoarthritis | Autologous bone marrow-derived MSC (BM-MSC) |
| Mesoblast Limited | United States | US FDA | 2024 | Steroid-refractory acute GvHD in paediatric patients 2 months and older | Allogeneic bone marrow-derived MSC / mesenchymal stromal cell therapy |
| Platinumlife Biotechnology (Beijing) Co., Ltd. | China | NMPA | 2025 | Steroid-refractory acute GvHD with predominant gastrointestinal involvement in patients aged 14 years and older | Allogeneic human umbilical cord-derived MSC (hUC-MSC) |