Globally, significant progress has been made in the clinical development stage of mesenchymal stem cell (MSC) drugs. According to statistics, 655 MSC drugs have entered the clinical development stage, far surpassing other types of stem cell therapies.

With the approval of **AmyMetoCell Injection**, China's first MSC therapeutic drug has been introduced. Currently, 17 MSC therapeutic drugs have been approved worldwide, with 10 derived from bone marrow, 3 from umbilical cord, 2 from adipose tissue, 1 from umbilical cord blood, and 1 from autologous corneal limbus.

**AmyMetoCell Injection**

Approved Country: China

Approval Date: January 2, 2025

Cell Type: Umbilical Cord Mesenchymal Stem Cells

Indication: For the treatment of acute graft-versus-host disease (aGVHD) with gastrointestinal involvement in patients aged 14 and above who have failed hormone therapy.

Price: Not yet disclosed

AmyMetoCell Injection utilizes human umbilical cord mesenchymal stem cells, functioning through immune regulation and tissue repair. Its mechanisms include inhibiting the overactivation of immune cells, regulating immune cell function, differentiating into specific cell types, and secreting various bioactive factors.

The development of this injection began in 2013, with the first submission of an Investigational New Drug (IND) application. Clinical trials were first announced in June 2020. In June 2024, the drug was included in the priority review and approval list, and a New Drug Application (NDA) was submitted in the same month.

Phase II clinical trial results showed that the drug demonstrated good efficacy and safety in treating hormone-resistant acute graft-versus-host disease. No significant safety risks related to the trial drug were observed during the clinical trials.

**Ryoncil**

Approved Country: United States

Approval Date: December 18, 2024

Cell Type: Allogeneic Bone Marrow Mesenchymal Stromal Cells

Indication: For the treatment of steroid-refractory acute graft-versus-host disease (SR-aGVHD) in children aged 2 months and above.

Price: Not yet disclosed

Dosage: Typically 8 doses. Each intravenous infusion is 2X10^6 MSC/kg, twice a week for 4 weeks, totaling 8 infusions. Infusions are spaced at least 3 days apart.

**Akuugo**

Approved Country: Japan

Approval Date: July 31, 2024 (Conditional and Time-Limited Approval)

Cell Type: Bone Marrow Mesenchymal Stem Cells

Indication: Improvement of chronic motor paralysis caused by traumatic brain injury (TBI)

Price: Not yet disclosed

AKUUGO is an allogeneic mesenchymal stem cell product that enhances the ability to regenerate nerve cells by temporarily transfecting the human Notch-1 intracellular domain gene into cultured cells. It is the world's first allogeneic cell therapy drug approved for chronic motor paralysis related to traumatic brain injury (TBI). Research results indicate that AKUUGO not only has neuroprotective effects but also promotes angiogenesis and exerts immunomodulatory functions.

**Vartocell**

Approved Country: Iran

Approval Date: 2020

Cell Type: Umbilical Cord Mesenchymal Stem Cells

Indication: Cerebral Palsy

Price: 100 million Iranian Rials (per vial containing 20 million cells), approximately $2,300

Vartocell is an umbilical cord mesenchymal stem cell product developed by Iran's Cell Tech Pharmed, primarily used for treating cerebral palsy. Approved in 2020, it is the world's first stem cell therapy drug targeting cerebral palsy.

**Stemirac**

Approved Country: Japan

Approval Date: November 21, 2018 (Conditional and Time-Limited Approval)

Cell Type: Autologous Bone Marrow Mesenchymal Stem Cells

Indication: For improving neurological dysfunction related to spinal cord injury.

Price: Approximately 15 million yen per dose (about $95,000)

Stemirac's main component is mesenchymal stem cells extracted from the patient's bone marrow fluid. These cells are cultured in vitro, suspended in a cryopreservation solution containing the patient's own serum, and then frozen. It is administered primarily via intravenous drip. In a Japanese Phase II clinical trial, Stemirac showed efficacy in improving neurological function in spinal cord injury patients, with acceptable safety.

**Alofisel**

Approved Authority: European Union (withdrawn in December 2024), Japan

Approval Date: March 23, 2018 (EU Approval); September 2021 (Japan Approval)

Cell Type: Adipose Mesenchymal Stem Cells

Indication: For the treatment of complex perianal fistulas in adult patients with Crohn's disease (CD)

Price: 5.62 million yen per dose (approximately $36,000)

Treatment Course: 6ml/vial, single treatment dose of 1.2x10^8 cells/24ml (4 vials in total)

Alofisel's approval was based on positive data from the pivotal Phase III clinical study ADMIRE-CD, which showed significant efficacy in treating complex perianal fistulas. However, in December 2024, the EU decided to withdraw Alofisel's market authorization due to insufficient data to confirm its efficacy.

**Mesestrocell**

Approved Country: Iran

Approval Date: 2018

Cell Type: Bone Marrow Mesenchymal Stem Cells

Indication: For the treatment of osteoarthritis

Price: 200 million Iranian Rials (approximately $4,600)

Dosage: Intra-articular injection of 2x10^7 cells per knee; 4x10^7 cells for both knees.

**StemSin**

Approved Country: Iran

Approval Date: 2018

Cell Type: Bone Marrow Mesenchymal Stem Cells

Indication: For the treatment of multiple sclerosis

Price: Not disclosed

**AlloStemSin**

Approved Country: Iran

Approval Date: 2018

Cell Type: Umbilical Cord Mesenchymal Stem Cells

Indication: For the treatment of amyotrophic lateral sclerosis (ALS)

Price: Not disclosed

**Temcell**

Approved Country: Japan

Approval Date: September 2015

Cell Type: Bone Marrow Mesenchymal Stem Cells

Indication: For the treatment of acute graft-versus-host disease (GvHD)

Price: 868,680 yen (approximately $7,700) per bag. A standard course involves 2 bags per week for 4 weeks, totaling 8 bags. Adult patients typically require 2-3 courses, meaning an average of at least 16 bags or up to 24 bags. Therefore, the total cost ranges from approximately $123,000 to $185,000.

Temcell, developed by Mesoblast and marketed by Japan's JCR Pharmaceuticals, is the world's first mesenchymal stem cell product for treating acute graft-versus-host disease (aGVHD).

**Stempeucel**

Approved Authority: European Union, India

Approval Date: June 2015 (EU Orphan Drug Designation); August 2020 (India Approval)

Cell Type: Bone Marrow Mesenchymal Stem Cells

Indication: For the treatment of critical limb ischemia (CLI), including Buerger's Disease and CLI caused by atherosclerotic peripheral arterial disease.

Price: $2,200 (2017)

**Holoclar**

Approved Authority: European Union

Approval Date: February 2015

Cell Type: Autologous Limbal Stem Cells

Indication: For the treatment of moderate to severe limbal stem cell deficiency (LSCD) caused by physical or chemical factors, particularly unilateral or bilateral LSCD due to eye burns.

Price: Not disclosed, but reports suggest a treatment cost of approximately $80,000 per eye.

Holoclar, developed by Italy's Chiesi Farmaceutici, is the first stem cell-based advanced therapy product and the first product for treating limbal stem cell deficiency (LSCD). This therapy repairs damaged corneal cells using in vitro-expanded autologous human corneal epithelial cells (containing stem cells), improving or resolving symptoms such as pain and photophobia, and enhancing visual acuity.

**NeuroNATA-R**

Approved Country: Korea

Approval Date: July 30, 2014

Cell Type: Autologous Bone Marrow Mesenchymal Stem Cells

Indication: For the treatment of amyotrophic lateral sclerosis (ALS) and other motor neuron diseases.

Price: Varies based on patient weight, ranging from approximately $18,000 to $72,000.

Dosage: Typically two injections every 4 weeks.

NeuroNATA-R, developed by Korea's Corestem, is the world's first stem cell-based therapy for ALS. It involves the injection of autologous bone marrow mesenchymal stem cells, offering neuroprotective effects that delay motor neuron death, thereby slowing ALS progression. Clinical trials have shown good safety and some efficacy.

**Prochymal**

Approved Country: Canada, New Zealand (withdrawn in 2016)

Approval Date: May 17, 2012

Cell Type: Bone Marrow Mesenchymal Stem Cells

Indication: For the treatment of acute graft-versus-host disease (GvHD) in children.

Price: $200,000 per course (typically 4 doses)

Prochymal, developed by Osiris Therapeutics, is the world's first approved allogeneic bone marrow mesenchymal stem cell therapy drug.

On May 17, 2012, Prochymal was approved by Health Canada for treating acute GvHD in children.

In 2012, Prochymal was approved in New Zealand but was withdrawn in 2016.

In 2013, Mesoblast acquired Prochymal from Osiris Therapeutics and renamed it Remestemcel-L.

In 2016, Remestemcel-L was approved in Japan under the brand name Temcell.

In December 2024, the US FDA approved Ryoncil (remestemcel-L), based on Prochymal, for treating steroid-refractory acute GvHD (SR-aGVHD) in children aged 2 months and above.

**Cupistem**

Approved Country: Korea

Approval Date: January 2012

Cell Type: Autologous Adipose Mesenchymal Stem Cells

Indication: For the treatment of complex perianal fistulas in Crohn's disease.

Price: Approximately 6 million Korean won (about $5,000 per treatment)

Cupistem received health insurance price approval from Korea's Health Insurance Review & Assessment Service (HIRA) in 2014.

**Cartistem**

Approved Country: Korea

Approval Date: January 2012

Cell Type: Umbilical Cord Blood Mesenchymal Stem Cells

Indication: For the treatment of degenerative arthritis and knee cartilage damage.

Price: $19,000 - $21,000

Umbilical cord blood mesenchymal stem cells, stimulated by injury factors in the damaged cartilage microenvironment, secrete growth factors, cytokines, and ligands, promoting cartilage differentiation, regulating inflammatory responses, inhibiting cartilage-degrading protein activity, and inducing cartilage regeneration.

Since its launch in 2012, Cartistem has seen a steady increase in surgical cases, from 228 in the first year to 1,237 in 2015, a fivefold increase. By 2024, the cumulative number of patients treated with Cartistem exceeded 30,000.

**CellGram**

Approved Country: Korea

Approval Date: July 1, 2011

Cell Type: Autologous Bone Marrow Mesenchymal Stem Cells

Indication: For the treatment of acute myocardial infarction (AMI)

Price: 18 million Korean won (approximately $15,000), not covered by health insurance.

In 2018, CellGram's sales peaked at 2.5 billion Korean won, then declined to 800 million Korean won in 2023.

At launch, CellGram was required to provide clinical data for 600 patients within 6 years. Pharmicell later applied to reduce this number to 60 but was refused, raising concerns about its future approval status.

With in-depth research into the mechanisms of MSC therapies and the continuous development of new indications, this innovative treatment holds promise for more patients. Meanwhile, scientists are exploring more effective delivery methods and optimizing treatment protocols to enhance efficacy and minimize potential side effects. We have reason to believe that in the near future, MSC therapies will demonstrate their unique value and immense potential in more disease areas, profoundly impacting global healthcare.