Stem Cell Therapy: Making Myths Real
Author: View Sir
Source: National and Regional Laboratory of Adult Stem Cells
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From Hiddink’s knee. "When I went to the hospital, it was like this..." Hiddink began to "haddle" in front of the reporter, drew a burst of kind laughter.
"In July this year, I walked like this..." He turned around, paused, and then trot, and the crowd applauded.
Hiddink, a well-known Dutch football coach, has brought this brand new stem cell medicine to the most intuitive curative effect display (screenshot video source: ch wonseok@YT) after receiving Cartistem treatment for 6 months.
Cartistem is 's first umbilical cord blood mesenchymal stem cell drug , and its indications include: knee cartilage damage and degenerative arthritis.
1 Cell therapy for osteoarthritis
Osteoarthritis, also known as degenerative osteoarthropathy, is closely related to age.
According to statistics, the total prevalence of osteoarthritis in my country is about 15%, more than 50% for people over 60 years old, and is as high as 80% for people over 75 years old, and it continues to increase with aging and obesity.
Cartilage Repair丨Source: SNU Seoul Hospital
An important cause of osteoarthritis is the poor regeneration ability of cartilage.
Cartilage tissue has no blood vessels, lymphatics, nerves, cells and nutrients can hardly reach damaged cartilage. People urgently need a method that can effectively regenerate cartilage.
In recent years, with the development of autologous chondrocyte transplantation and stem cell tissue engineering technology, articular cartilage diseases have gradually entered the era of cell therapy.
2 Cartilage repair cell therapy development
Data source: Dalby et al., Biochemical Journal
It can be seen that these cellular drugs are chondrocyte products (9) and mesenchymal stem cells products ( 8) Mainly.
At the same time, ACI has developed from the 1st generation to the 3rd generation.
first generation: P-ACI is an in vitro culture of autologous chondrocytes, combined with autologous periosteum to cover the defect area.
2nd generation: C-ACI replaces autologous periostium with collagen membrane. The clinical effect is equivalent to that of the first generation, but it reduces cartilage hyperplasia.
third generation: M-ACI is also called matrix-induced ACI technology, which is to plant chondrocytes on a biological scaffold material and use absorbable thread suture to fix it. The curative effect is better than the previous two generations.
3 Introduction of main cell medicines
The treatment process includes:
√ The surgeon removes the patient’s healthy cartilage tissue
√ The laboratory separates the packaging cells after expansion and cultures them. p1p
√ Surgery again,Infusion to the damaged cartilage site and seal with periosteum
In 2016, Vericel launched a new product: MACI.
Carticel then withdrew from the market.
ChondroCelect and Carticel are both the first generation of ACI products.
Over time, the main trend of clinical application has shifted to the 2nd and 3rd generation ACI products.
In addition to the reimbursement policy of major EU countries,
ChondroCelect was delisted in 2016.
Cartistem product contains 1.5ml of mesenchymal stem cells (7.5×10*6) derived from cord blood and 4% hyaluronic acid.
According to the results of the Cartistem Phase III clinical study, 98% of patients showed therapeutic effects. Even in the case of large cartilage defects, it also shows an excellent cartilage regeneration effect. In particular, it has been proven that even a single treatment has good results.
Currently, the product has completed phase I and phase IIa clinical trials in the United States, and is currently conducting phase II clinical trials in Japan.
Maci is a cartilage tissue engineering product cultured on porcine collagen membrane. It provides surgeons with a new tool to repair cartilage damage.
In 2018, data from a 5-year study published in The American Journal of Sports Medicine showed that MACI is usually more effective than microfractures for lesions larger than 3cm².
The price of US$40,000 makes MACI expensive, but American insurance companies have already taken action.
4 Market performance
Currently, the market performance of Cartistem and Maci is relatively outstanding, and even the epidemic has not caused a big impact.
Cartistem Since its launch, the cumulative sales of have exceeded 18,000 doses of . In 2017, Medipost ended the marketing entrusted contract , and sales increased significantly after turning to self-operating.
From 2017 to 2020, Cartistem has sold over 10 billion won for four consecutive years from 2017 to 2020. (approximately US$9 million) . From the perspective of market share, is obviously better than the other three stem cell drugs in Korea, .
Medipost is also working hard to develop Cartistem into a world-class stem cell therapy.
However, in the past two years, its overseas expansion has encountered difficulties. Of the 6 Cartistem copyright transfer contracts signed with domestic and foreign companies, 4 have expired or are being terminated.
Source: vcel.com
Although affected by the epidemic, MACI's sales in 2020 will still reach 94.4 million US dollars .
Source: vcel.com
In the first half of 2021, Maci sales increased by 42% compared to the same period last year.
Maci's "going to sea" attempt was not smooth.
In July 2013, Maci was approved as an advanced therapy in Europe. However, for the European health system with tight funding, Maci is too expensive to be included in reimbursement.
As a result, Maci's European manufacturing base was closed in 2014, and EMA subsequently suspended its license.
5 Domestic situation and outlook
At present,Three new stem cell drugs for the treatment of knee osteoarthritis have obtained the implied approval of the National Medical Products Administration (NMPA) clinical trial.
They are:
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CBM-ALAM.1 allogeneic human adipose-derived mesenchymal progenitor cell injection
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Sibyman’s autologous human adipose-derived mesenchymal progenitor cells Injection
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Human Umbilical Cord Mesenchymal Stem Cell Injection
The first cartilage repair cell drug Carticel has been on the market for more than 20 years. The market performance of its replacement product Maci Also getting better.
In the treatment of cartilage injury and osteoarthritis, the strength of cellular drugs has been verified. With the implementation of relevant domestic policies, new cellular drugs registered for clinical trials have sprung up, and the development of the industry is accelerating.
We believe that the cellular medicine for osteoarthritis is getting closer and closer to patients in China.
Who holds the color to practice dancing in the air: Stem cell basic and clinical research progress
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