Anti-inflammatory Repair

Osteoarthritis (OA) is a degenerative joint disease that severely impacts patients' quality of life and imposes a significant burden on their families. OA not only causes joint pain, deformity, and dysfunction but also elevates the risk of cardiovascular adverse events, lower-extremity deep-vein thromboembolism, hip fractures, and all-cause mortality.

 

The gradual progression from healthy bone and joint to osteoarthritis.

 

Currently, there are over 300 million OA patients globally. In China, the prevalence of primary OA among individuals over 40 years old has reached 46.3%. With the aging population, the prevalence of OA is expected to rise. Knee osteoarthritis (KOA) is the most common form, characterized by knee pain and limited mobility, and is a major cause of disability among middle-aged and elderly populations in China.

 

Although various treatments are available, each has limitations. Many treatments face safety or tolerability issues, restricting dosage and clinical benefits. Therefore, there is an urgent need for a therapeutic agent that promotes cartilage development, has minimal adverse effects, and improves long-term patient outcomes.

 

Mesenchymal Stem Cells (MSCs) are a group of stem cells with self-renewal and multi-directional differentiation potential. Through their potent paracrine functions, MSCs can promote the repair and regeneration of damaged tissues and suppress inflammation, eventually restore and maintain tissue homeostasis through repair, regeneration, and anti-inflammatory effects.

 

Mechanism of MSC in KOA Treatment

 

MSCs lack MHC class II molecules and costimulatory molecules, granting them immune privilege. Allogeneic MSC transplantation does not provoke severe immune rejection. These properties provide broad prospects for their application in regenerative medicine and cell therapy, particularly in treating tissue injuries and autoimmune diseases.

 

Induced pluripotent stem cells (iPSC) have the potential for unlimited expansion, differentiation into the three germ layers, and easy genetic modification. Based on the characteristics of unlimited expansion and differentiation into the three germ layers, iPSCs can be used to produce large batches of MSCs, addressing issues of heterogeneity, standardization, scalability, and cost associated with adult-derived MSCs. Genetic modifications at the iPSC stage can yield MSCs with enhanced functions with scalability while retaining homogeneity. 
 
"NCR100 Injection for the Treatment of KOA" - The First iPSC-derived MSC Cell Therapy Approved for Clinical Trials in China
 
This product, developed by Nuwacell, is industrially and large-scale produced under cGMP standards,
offering a novel and effective treatment option for KOA patients.
Nuwacell plans to develop additional iMSC-based therapies for various therapeutic indications to meet diverse patient needs. 
 

 

References:
  • iMSC
    Knee Osteoarthritis (CTR20232672)
    Pipeline Progress
    Phase I/II clinical trials
  • iMSCplus
    undisclosed
    Pipeline Progress
    IND-enabling studies