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Updated: Jun 14, 2025
Corneal Tissue Engineering: An In Vitro Model of the Stromal-nerve Interactions of the Human Cornea
Published on: January 24, 2018
Isolation, Culture, and Quality Assessment of Clinical-Grade Corneal Stromal Stem Cells
Mithun Santra1, Moira L Geary1, Martha L Funderburgh1
1Corneal Regeneration Laboratory, Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
Abstract:
The challenge of treating corneal scarring through keratoplasties lies in the limited availability of donor tissue. Various studies have shown the therapeutic use of cultivated corneal stromal stem cells (CSSCs) to mitigate tissue inflammation and suppress fibrosis and scar tissue formation in preclinical corneal wound models. To develop CSSC therapy for clinical trials on patients with corneal scarring, it is necessary to generate clinical-grade CSSCs in compliant to Good Manufacturing Practice (GMP) regulations. This chapter elucidates human CSSC isolation, culture, and cryopreservation under GMP-compliant conditions. It underscores quality assessment encompassing morphological traits, expression of stemness markers, anti-inflammatory activity, and keratocyte differentiation potency.
Insights
Cultivated corneal stromal stem cells (CSSCs) offer a promising alternative to donor tissue for treating corneal scarring. This study details GMP-compliant methods for generating clinical-grade CSSCs for future patient trials.
Area of Science:
- Ophthalmology
- Regenerative Medicine
- Cell Therapy
Background:
- Corneal scarring significantly impacts vision, with keratoplasty limited by donor tissue scarcity.
- Cultivated corneal stromal stem cells (CSSCs) show potential in preclinical models to reduce inflammation and fibrosis.
- Clinical application requires Good Manufacturing Practice (GMP)-compliant CSSC production.
Purpose of the Study:
- To outline GMP-compliant methods for isolating, culturing, and cryopreserving human CSSCs.
- To establish quality assessment criteria for clinical-grade CSSCs.
Main Methods:
- Human CSSC isolation and expansion under GMP conditions.
- Cryopreservation protocols for long-term storage.
- Quality control assessments including morphology, stemness markers, anti-inflammatory function, and differentiation capacity.
Main Results:
- Established protocols for producing clinical-grade human CSSCs.
- Defined quality assessment parameters ensuring cell potency and safety.
- Demonstrated feasibility of GMP-compliant CSSC generation for therapeutic use.
Conclusions:
- GMP-compliant production of CSSCs is achievable.
- Standardized quality assessment ensures therapeutic potential for corneal scarring treatment.
- This work paves the way for clinical trials using CSSC therapy.
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