Trial Outcomes & Findings for Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft (NCT NCT02592330)

Last Updated: 2025-01-15

Results Overview

The occurrence of the following adverse events at any time during the 18 months of follow-up in the recipient eye will serve as the primary safety events of interest. 1. Ocular Infection (defined as endophthalmitis or microbial keratitis \[bacterial, fungal, parasitic\]: 2. Corneal Perforation 3. Graft Detachment ≥50%

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

18 Months

Results posted on

2025-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Cultivated Autologous Limbal Epithelial Cell (CALEC) Graft Participants had a corneal biopsy in their non-diseased eye. A graft was manufactured for transplant using limbal epithelial cells, and transplanted into the diseased eye (CALEC transplant).	Control Conjunctival Limbal Autograft (CLAU) Participants who were randomized to receive Conjunctival limbal autograft (CLAU) - Prior to this arm being ended. We dropped the control arm, which was IRB approved, due to low enrollment.
Overall Study STARTED	16	1
Overall Study COMPLETED	14	1
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cultivated Autologous Limbal Epithelial Cell (CALEC) Graft Participants had a corneal biopsy in their non-diseased eye. A graft was manufactured for transplant using limbal epithelial cells, and transplanted into the diseased eye (CALEC transplant).	Control Conjunctival Limbal Autograft (CLAU) Participants who were randomized to receive Conjunctival limbal autograft (CLAU) - Prior to this arm being ended. We dropped the control arm, which was IRB approved, due to low enrollment.
Overall Study Withdrawal by Subject	1	0
Overall Study Failed Biopsy	1	0

Baseline Characteristics

Limbal Stem Cell Deficiency (LSCD) Treatment With Cultivated Stem Cell (CALEC) Graft

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 18 Months

Population: All participants receiving a CALEC transplant or CLAU transplant.

Outcome measures

Outcome measures
Measure	CALEC n=14 Participants Participants undergoing a biopsy	CLAU (Control) n=1 Participants Participants undergoing CLAU procedure.
Primary Safety Events of Interest Number of Participants with Ocular Infections	1 Participants	0 Participants
Primary Safety Events of Interest Number of Participants with Corneal Perforations	0 Participants	0 Participants
Primary Safety Events of Interest Number of Participants with Graft Detachments	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 18 Months

Population: Total number of biopsies performed. Fourteen of 16 biopsies (in 15 participants) resulted in a manufacturing success. Two failures occurred in the initial recruitment phase. One of the participant, had a second biopsy and successful transplant; the other elected not to return.

Each biopsy attempt will be classified as a "feasibility success" if it produced at least one construct that met all of the Quality Control (QC) release criteria. Manufacturing feasibility will be evaluate on a biopsy level (denominator is the total number of biopsies).The number and percentage of biopsy attempts resulting in a feasibility success will be calculated.

Outcome measures

Outcome measures
Measure	CALEC n=16 Biopsies Participants undergoing a biopsy	CLAU (Control) Participants undergoing CLAU procedure.
Manufacturing Feasibility Measures	14 Biopsies	—

SECONDARY outcome

Timeframe: 18 Months

Population: All participants undergoing a corneal biopsy. The total number of biopsy attempts are summarized.

The primary efficacy outcome will be a binary "Complete Success" of the graft defined as improvement in corneal surface integrity

Outcome measures

Outcome measures
Measure	CALEC n=14 Participants Participants undergoing a biopsy	CLAU (Control) n=1 Participants Participants undergoing CLAU procedure.
Measure of Transplant Efficacy Complete Success : 3 Months Post Transplant	7 Participants	1 Participants
Measure of Transplant Efficacy Complete Success : 12 Months Post Transplant	11 Participants	0 Participants
Measure of Transplant Efficacy Complete Success : 18 Months Post Transplant	10 Participants	1 Participants

Adverse Events

CALEC

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

CLAU

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CALEC n=16 participants at risk Participants had a corneal biopsy in their non-diseased eye. A graft was manufactured for transplant using limbal epithelial cells and transplanted into the diseased eye (CALEC transplant)	CLAU n=1 participants at risk Participants had a corneal biopsy in their non-disease eye, and transplanted into the the diseased eye.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.

Other adverse events

Additional Information

Michael Cheung, MS, CCRP (Clinical Research Project Manager)

Massachusetts Eye and Ear

Phone: 617-573-6981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	CALEC n=14 Participants Participants undergoing a biopsy with CALEC	CLAU (Control) n=1 Participants Participant(s) undergoing a biopsy with CLAU	Total n=15 Participants Total of all reporting groups
Age, Continuous	42.0 Years n=5 Participants	53.0 Years n=7 Participants	46.0 Years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	0 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants	1 Participants n=7 Participants	15 Participants n=5 Participants
Epithelial Integrity	15.0 units on a scale n=5 Participants	10.0 units on a scale n=7 Participants	15.0 units on a scale n=5 Participants
Neovascularization	7.5 Neovascular Area (% of total area) n=5 Participants	3.6 Neovascular Area (% of total area) n=7 Participants	7.2 Neovascular Area (% of total area) n=5 Participants
Ocular Surface Disease Index Score	40.6 units on a scale n=5 Participants	95.5 units on a scale n=7 Participants	41.7 units on a scale n=5 Participants
Symptom Assessment in Dry Eye Score	35.4 units on a scale n=5 Participants	72.7 units on a scale n=7 Participants	39.1 units on a scale n=5 Participants

Measure	CALEC n=16 participants at risk Participants had a corneal biopsy in their non-diseased eye. A graft was manufactured for transplant using limbal epithelial cells and transplanted into the diseased eye (CALEC transplant)	CLAU n=1 participants at risk Participants had a corneal biopsy in their non-disease eye, and transplanted into the the diseased eye.
Eye disorders Allergic Conjunctivitis	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Anterior Chamber Flare	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Blepharitis (Eyelid Irritation)	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Conjunctival Hyperemia	62.5% 10/16 • Number of events 10 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Conjunctival Injection	12.5% 2/16 • Number of events 2 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Corneal Bleeding	56.2% 9/16 • Number of events 9 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Corneal Edema	43.8% 7/16 • Number of events 7 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Corneal Epithelium Defect	93.8% 15/16 • Number of events 15 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 2 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Corneal Neovascularization	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Dry Eye	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Ecchymosis - Skin	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eye Acne	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eye Discharge	12.5% 2/16 • Number of events 2 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eye Infection NOS	12.5% 2/16 • Number of events 2 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eye Irritation	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eye Itching	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eye Pain	62.5% 10/16 • Number of events 10 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eye Redness	0.00% 0/16 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eye Tearing	31.2% 5/16 • Number of events 5 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eyelid Disorder	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Foreign Body Sensation	25.0% 4/16 • Number of events 5 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Intraocular Pressure Increased	18.8% 3/16 • Number of events 4 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Persistent Corneal Epithelial Defect	31.2% 5/16 • Number of events 6 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Photophobia	43.8% 7/16 • Number of events 10 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Sensitivity to Light	12.5% 2/16 • Number of events 2 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Soreness in Eyes	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Subconjunctival Hemorrhage	68.8% 11/16 • Number of events 11 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Blurry Vision	12.5% 2/16 • Number of events 2 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Conjunctival Disorder	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Corneal Haze	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Eyelid Margin Crusting	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Foreign Body Sensation in Eyes	12.5% 2/16 • Number of events 2 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Hazy Vision	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Eye disorders Subconjunctival/Conjunctival Hemorrhage	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Injury, poisoning and procedural complications Bruise	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Gastrointestinal disorders Diarrhea	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
General disorders Fatigue	0.00% 0/16 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
General disorders Fever	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Injury, poisoning and procedural complications Foot Injury	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Nervous system disorders Headache	56.2% 9/16 • Number of events 11 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Nervous system disorders Migrane Headache	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Gastrointestinal disorders Nausea	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/16 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Respiratory, thoracic and mediastinal disorders Streptococcal Sore	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
General disorders Toothache	6.2% 1/16 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	0.00% 0/1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	0.00% 0/16 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.
Gastrointestinal disorders Vomiting	0.00% 0/16 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.	100.0% 1/1 • Number of events 1 • 18 Months Adverse Events Occurring in the Recipient Eye. Adverse Events Occurring in the Donor Eye. Systemic Adverse Events.