Drugdu.com expert's response:

Stem cell therapy has entered the clinical treatment stage and is continuously advancing globally, with multiple countries approving related therapies for specific diseases, while numerous clinical trials are underway to verify their safety and efficacy.

I. Approved Stem Cell Therapies

United States: In 2010, the FDA approved Prochymal® (allogeneic bone marrow mesenchymal stem cells) for the treatment of pediatric graft-versus-host disease (GvHD), marking the world's first approved stem cell drug.

European Union: In 2015, the EU approved Holoclar® (autologous limbal stem cells) for the treatment of severe limbal stem cell deficiency.

Japan: In 2018, Japan approved Temcell® (allogeneic bone marrow mesenchymal stem cells) for the treatment of GvHD.

South Korea: In 2022, South Korea approved Cartistem® (umbilical cord blood-derived mesenchymal stem cells) for the treatment of degenerative arthritis.

China: In 2024, China's National Medical Products Administration (NMPA) approved "Aimaituosai Injection" (human umbilical cord mesenchymal stem cell injection) for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD), marking China's first approved stem cell drug.

II. Global Clinical Trial Progress

According to ClinicalTrials.gov data, over 7,000 stem cell-related clinical trials are underway globally, covering various disease areas including neurological disorders (such as Parkinson's disease, spinal cord injury), cardiovascular diseases (such as heart failure), autoimmune diseases (such as Crohn's disease), and orthopedic diseases (such as osteoarthritis). Some trials have yielded positive results. For example, clinical trials for Parkinson's disease have shown that stem cell transplantation can improve patients' motor function, while trials for diabetes have indicated that stem cell therapy can promote the regeneration of pancreatic beta cells and reduce insulin dependency.

III. Technological Breakthroughs and Application Expansion

Induced Pluripotent Stem Cells (iPSCs): iPSC technology can avoid ethical controversies and differentiate into specific cell types, offering possibilities for personalized treatment. For instance, Kyoto University's iPS Cell Research Institute has conducted clinical trials of iPSC-derived retinal cell transplantation for age-related macular degeneration.

3D Bioprinting: Combining stem cell technology with 3D printing can construct tissues or organs with physiological functions, providing new avenues for organ transplantation.

Gene Editing Technology: Tools like CRISPR/Cas9 combined with stem cells can correct pathogenic gene mutations and treat genetic diseases.

IV. Challenges

Safety: Stem cell therapy may pose risks such as tumor formation and immune rejection, requiring strict monitoring.

Standardization: Variations in stem cell quality prepared by different laboratories necessitate the establishment of unified production and quality control standards.

Cost: The complexity of stem cell therapy technology and high costs limit its widespread application.

V. Future Prospects

1. With continuous technological advancements and in-depth clinical trials, stem cell therapy is expected to achieve breakthroughs in more disease areas.

2. International cooperation and improved regulatory policies will accelerate the clinical translation of stem cell therapies.

3. It is anticipated that within the next 5-10 years, stem cell therapy will become a vital component of routine medical practices.