Table 1 Baseline Demographic and Clinical Characteristics

From: Cultivated autologous limbal epithelial cell (CALEC) transplantation for limbal stem cell deficiency: a phase I/II clinical trial of the first xenobiotic-free, serum-free, antibiotic-free manufacturing protocol developed in the US

Participant Characteristics

N = 14

Age at Enrollment (years) - Median [range]

42.0 [24.0, 78.0]

Sex: Female – n (%)

1 (7%)

Race/Ethnicity – n (%)

 White

12 (86%)

 Asian

1 (7%)

 Unknown/Not Reported

1 (7%)

Recipient Eye Characteristics

N = 14

Epithelial Integrity

 Epithelial Defect– n (%)

4 (29%)

 Epithelial Defect Surface Area (mm2), in 4 eyes with defect - All epithelial defects

0.3, 6.5, 16.0, 21.6

 Cornea Surface Staining (NEI Grade Scale of 0 to 15)a - Median [range]

15.0 [10.0, 15.0]

Neovascularization

 Neovascular Area (% of Total Area)b - Median [range]

7.5 [0.5, 24.2]

 Clock Hours of Limbal Involvement - Median [range]

12.0 [8.0, 12.0]

 Central 5 mm involved – n (%)

12 (86%)

Symptomatology

 OSDI Score (Scale of 0 to 100) - Median [range]

40.6 [6.8, 100.0]

 SANDE Score (Scale of 0 to 100)c - Median [range]

35.4 [6.5, 82.0]

Other Recipient Eye Characteristics

Cause of LSCD – n (%)

 Chemical burn

9 (64%)

 Thermal burn

2 (14%)

 Othere

3 (21%)

 Time from Injury to CALEC (years) - Median [range]

2 (0, 32)

 Number of Reconstructive Surgeries Prior to CALEC - Median [range]

0.5 (0.0, 4.0)

Corneal Opacification (Fantes Scale of 0 to 4) – n (%)

 2

2 (14%)

 3

6 (43%)

 4

6 (43%)

Visual Acuity – n (%)

 20/40 to 20/100

3 (21%)

 20/300 to 20/400

2 (14%)

 Hand motion or count fingers

9 (64%)

IOP (mmHg)

 Median [range]

14.5 [8.0, 24.0]

Positive Culture Growth from Conjunctival Swab – n (%)d

10 (77%)

  1. aBased on clinical assessment.
  2. bBased on digital slit lamp photos using mathematical software to calculate.
  3. cBased on multiplying 2 scores from 2 questions and taking square root.
  4. dConjunctival swab was performed 3 months prior at initial screening visit, and not repeated at baseline. If positive, participants were treated with preoperative antibiotics (vancomycin).
  5. eOther causes include contact lens use and Herpes Zoster Ophthalmicus.