Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft
Condition: Limbal Stem Cell Deficiency
MeSH terms: Limbal Stem Cell Deficiency
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main aim of the study is to determine the safety and feasibility of a cultivated
      autologous limbal epithelial cell (CALEC) transplantation in the treatment of limbal stem
      cell deficiency.
    

Detailed description: 
      This is an open label, single center study to assess safety, feasibility, and efficacy of
      Cultivated Autologous Limbal Epithelial Cell (CALEC) grafts in 17 patients with unilateral
      limbal stem cell deficiency (LSCD).

      Participants will have a corneal biopsy in their non-diseased eye, which will provide cells
      for the creation of the CALEC graft. The CALEC will be made at the Good Manufacturing
      Practice (GMP) Laboratory, Dana Farber Cancer Institute and transported to Mass. Eye and Ear
      Infirmary for application to the participant's diseased eye during their standard corneal
      reconstruction procedure. Subjects will be monitored up to month 18 post-transplant to assess
      for any delayed adverse events of the product (CALEC) or procedure as well as assessment of
      the durability of the transplant.
    

Intervention name(s): Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft; Cultivation of Limbal epithelial cells into a graft; CALEC Transplant
Intervention type(s): Procedure; Biological; Procedure
Intervention description(s): Cultivated autologous limbal epithelial cell (CALEC) therapy utilizes a bio-engineered composite of ex vivo expanded autologous corneal epithelial cells and an FDA-approved amniotic membrane (AmnioGraft®, Bio-Tissue, Inc.) to reconstruct the ocular surface. A small biopsy (2-3 mm2) from the patient's contralateral eye serves as a source epithelial (stem) cells that are expanded on the amniotic membrane in culture and the resulting product is surgically transplanted onto the cornea after excision of the fibrovascular pannus.; A graft is manufactured for transplant; Limbal epithelial cells are obtained from the healthy fellow eye and cultivated in a lab for later transplantation into the diseased eye.
Other intervention name(s): Cultivated Autologous Limbal Epithelial Cell (CALEC); Conjunctival Limbal Autograft
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive the study intervention, a stem cell graft cultivated from their own cells.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LSCD treatment; Limbal Stem Cell Deficiency; CALEC; Cultivated Autologous Limbal Epithelial Cell Transplantation; Corneal epithelial stem cells; Corneal scarring; Corneal opacity; Chemical injury eye; Thermal injury eye; Autologous stem cell; Epithelial defect; Corneal cloudiness; Ocular burn; Ocular injury; Autograft; Conjunctival Limbal Autograft; LSCD research; Chronic contact lens wear; Chronic keratoconjunctivitis; Corneal conjunctivalization; Corneal fibrovascular pannus; Corneal neovascularization; Corneal regeneration; Infectious keratitis; Limbal epithelial stem cell deficiency; Ocular injury drug toxicity; Ocular surface disorder; Neovascularization pannus; Neurotrophic keratitis; Ocular surface Inflammation; Eye injury ionizing radiation; Eye injury ultraviolet radiation; Corneal pannus; Corneal wound healing; Neurotrophic keratopathy; LSCD trial; Stem cell therapy; Epithelial surface integrity; Regrowing corneas