In this procedure, only a small limbal biopsy from the healthy fellow eye will be used to expand the stem cells in a good manufacturing practice (GMP) facility at the Dana Farber Cancer Institute with a highly controlled technique. After 2-3 weeks, the eye with LSCD will undergo the reconstruction using the expanded cells. By this procedure, the risk to the healthy fellow eye is minimal. This randomized study will enroll 24 patients with unilateral limbal stem cell deficiency; 17 will receive CALEC and 7 will undergo the standard of care conjunctival limbal autograft (CLAU) as the control. All patients will be followed for 18 months. Investigators, study personnel, and subjects will be aware of the study assignment, given the different procedures required for each, during and after surgery.

 

 

Inclusion Criteria:

• Unilateral limbal stem cell deficiency (LSCD)
• 18-80 years old
• Conjunctivalization / fibrovascular pannus –Affected Eye >2 mm from the limbus ≥6 clock hours
• Optional: Lack of limbal palisades of Vogt ≥9 clock hours

 

Exclusion Criteria:

Ocular Exclusion:

• Corneal or ocular surface infection within 30 days prior to study entry
• History of allo-limbal transplantation
• Ocular surface malignancy
• Severe cicatricial eye disease
• Schirmer’s test
  • ≤ 2mm in LSCD eye
  • ≤ 5mm in unaffected eye
• Conjunctivalization / fibrovascular pannus in unaffected eye >2 mm from the limbus ≥3 clock hours
• Lack of limbal palisades of Vogt for ≥3 clock hours in unaffected eye

Systemic Exclusion:

• HIV infection or AIDS, active hepatitis B or C
• Pregnancy (positive test) or lactation.
• Uncontrolled diabetes with most recent HgA1c >8.5%
• Inability to tolerate monitored anesthesia
• Signs of current infection, including fever and current treatment with antibiotics

 

 

To Learn More: