Ann: CYP-001s FDA Approval Pathway Not Impeded, page-12

And since you mentioned chatgpt here is the response to are iPSC's safe. I didn't bring chatgpt up by the way, so now I guess you will say they are out of date?

are ipsc's safe

ChatGPT said:

Great question — let’s unpack that carefully.

Induced pluripotent stem cells (iPSCs) are a type of stem cell created by reprogramming adult somatic cells (like skin or blood cells) to revert them into a pluripotent state, meaning they can differentiate into almost any cell type in the body. They’re hugely valuable for research, drug testing, disease modeling, and regenerative medicine.

As for safety — it depends on the context of their use.
Here’s a breakdown:

✅ iPSC Safety Positives:

• Ethically preferable: No embryos are destroyed to create them.

• Patient-specific potential: You can generate iPSCs from a patient’s own cells, minimizing the risk of immune rejection.

• Lab research & disease modeling: In vitro uses are considered safe.

⚠️ iPSC Safety Concerns:

• Genetic instability: The reprogramming process can introduce genetic mutations or epigenetic abnormalities.

• Tumorigenicity: Like embryonic stem cells, iPSCs can form teratomas (benign tumors of mixed tissue) if undifferentiated cells are transplanted.

• Reprogramming factors: Traditional methods used viral vectors to introduce genes like c-Myc, which is oncogenic (cancer-promoting). Newer, safer techniques (non-integrating methods like episomal vectors, mRNA, or CRISPR-based systems) reduce this risk but aren’t entirely risk-free.

• Incomplete differentiation: If cells aren’t fully or correctly differentiated before transplantation, unintended effects can occur.

Current Status:

• In lab and preclinical contexts, they’re widely used and relatively safe.

• In clinical trials (there are a handful ongoing globally — e.g., for macular degeneration, Parkinson’s), safety is still being rigorously tested.

• Regulatory authorities like the FDA or EMA closely oversee any therapeutic use.

In summary:
✅ Safe in lab research.
⚠️ Potential risks for clinical applications — being actively addressed through better reprogramming, differentiation, and screening techniques.