A Full Good Manufacturing Practice-Compliant Protocol for Corneal Stromal Stem Cell Cultivation.

Area of Science:

• Ophthalmology
• Regenerative Medicine
• Cell Biology

Background:

• Corneal scarring causes significant global blindness, with limited treatment options due to donor tissue scarcity.
• Current treatments like corneal transplantation are insufficient to meet patient demand.
• Cell-based therapies offer a promising alternative for corneal regeneration.

Purpose of the Study:

• To develop a Good Manufacturing Practice (GMP)-compliant protocol for isolating and expanding human corneal stromal stem cells (CSSCs).
• To establish a scalable method for producing clinical-grade CSSCs for potential transplantation.
• To address the critical shortage of donor corneas for treating corneal scarring.

Main Methods:

• Utilized surgical dissection of human corneal tissues for CSSC isolation.
• Established an ex vivo expansion protocol for CSSCs.
• Characterized CSSC yield and suitability for therapeutic use.

Main Results:

• Developed a GMP-compliant protocol for human CSSC isolation and expansion.
• Demonstrated donor tissue quality and freshness impact CSSC yield and characteristics.
• Achieved generation of up to 0.5 billion CSSCs per cornea, with passage 3 cells suitable for treatment.

Conclusions:

• The presented protocol enables the production of clinical-grade CSSCs.
• This advancement supports the development of cell-based therapies for corneal scarring.
• The method holds potential for future clinical trials and improved treatment accessibility.