Trial Outcomes & Findings for Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration (NCT NCT02286089)

Last Updated: 2026-01-29

Results Overview

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. The AE's were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 3.0.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years)

Results posted on

2026-01-29

Participant Flow

The enrollment into the study was staggered with 4 week intervals between the first 3 cohorts to allow for data safety monitory board (DSMB) review. Accumulated data of participants was reviewed by the DSMB before continuation to Cohort 4. All four cohorts were then followed in parallel.

Participant milestones

Participant milestones
Measure	Cohort 1 Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Overall Study STARTED	3	3	6	12
Overall Study COMPLETED	2	2	0	0
Overall Study NOT COMPLETED	1	1	6	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Overall Study Ongoing in Study	1	1	4	10
Overall Study Withdrawal by Subject	0	0	2	2

Baseline Characteristics

Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 n=3 Participants Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 n=3 Participants Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 n=6 Participants Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 n=12 Participants Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.	Total n=24 Participants Total of all reporting groups
Age, Continuous	77.4 Years STANDARD_DEVIATION 2.7 • n=35 Participants	74.4 Years STANDARD_DEVIATION 8.7 • n=4328 Participants	80.4 Years STANDARD_DEVIATION 9.9 • n=8687 Participants	78.1 Years STANDARD_DEVIATION 8.2 • n=153 Participants	76.9 Years STANDARD_DEVIATION 8.0 • n=200 Participants
Sex: Female, Male Female	2 Participants n=35 Participants	3 Participants n=4328 Participants	2 Participants n=8687 Participants	6 Participants n=153 Participants	13 Participants n=200 Participants
Sex: Female, Male Male	1 Participants n=35 Participants	0 Participants n=4328 Participants	4 Participants n=8687 Participants	6 Participants n=153 Participants	11 Participants n=200 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=35 Participants	3 Participants n=4328 Participants	6 Participants n=8687 Participants	12 Participants n=153 Participants	24 Participants n=200 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants
Race (NIH/OMB) White	3 Participants n=35 Participants	3 Participants n=4328 Participants	6 Participants n=8687 Participants	12 Participants n=153 Participants	24 Participants n=200 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=153 Participants	0 Participants n=200 Participants

PRIMARY outcome

Timeframe: From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years)

Population: Safety Population included all participants who received OpRegen in the study.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 n=3 Participants Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 n=6 Participants Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 n=12 Participants Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Percentage of Participants With Treatment Emergent Adverse Events Blood and lymphatic system disorders	33.3 percentage of participants	33.3 percentage of participants	0 percentage of participants	8.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Cardiac disorders	33.3 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Ear and labyrinth disorders	66.7 percentage of participants	33.3 percentage of participants	16.7 percentage of participants	8.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Eye disorders	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Investigations	100 percentage of participants	66.7 percentage of participants	33.3 percentage of participants	75.0 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Musculoskeletal and connective tissue disorders	66.7 percentage of participants	66.7 percentage of participants	0 percentage of participants	33.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Psychiatric disorders	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Surgical and medical procedures	100 percentage of participants	66.7 percentage of participants	0 percentage of participants	16.7 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Vascular disorders	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	16.7 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Renal and urinary disorders	0 percentage of participants	0 percentage of participants	33.3 percentage of participants	0 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Endocrine disorders	0 percentage of participants	0 percentage of participants	0 percentage of participants	8.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Gastrointestinal disorders	66.7 percentage of participants	66.7 percentage of participants	0 percentage of participants	33.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events General disorders and administration site conditions	66.7 percentage of participants	100 percentage of participants	50.0 percentage of participants	16.7 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Infections and infestations	100 percentage of participants	66.7 percentage of participants	50.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Injury, poisoning and procedural complications	66.7 percentage of participants	100 percentage of participants	50.0 percentage of participants	16.7 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Metabolism and nutrition disorders	0 percentage of participants	0 percentage of participants	16.7 percentage of participants	33.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Neoplasms benign, malignant and unspecified (incl cysts and polyps)	0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	25.0 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Nervous system disorders	0 percentage of participants	33.3 percentage of participants	50.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Skin and subcutaneous tissue disorders	33.3 percentage of participants	33.3 percentage of participants	33.3 percentage of participants	8.3 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Product issues	66.7 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Treatment Emergent Adverse Events Respiratory, thoracic and mediastinal disorders	66.7 percentage of participants	66.7 percentage of participants	16.7 percentage of participants	0 percentage of participants

PRIMARY outcome

Timeframe: Baseline, Month 12

Population: Safety Population included all participants who received OpRegen in the study.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 n=3 Participants Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 n=6 Participants Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 n=12 Participants Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Change From Baseline in Intraocular Pressure (IOP) Baseline	13.3 mmHg Standard Error 2.3	14.0 mmHg Standard Error 0.0	13.7 mmHg Standard Error 3.7	14.6 mmHg Standard Error 3.1
Change From Baseline in Intraocular Pressure (IOP) Change from Baseline at Month 12	1.0 mmHg Standard Error 2.6	1.0 mmHg Standard Error 1.7	-0.4 mmHg Standard Error 2.5	-0.6 mmHg Standard Error 1.4

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Efficacy Population included all participants who received OpRegen in the study and for whom imaging data were available.

The GA lesion area was based on available Fundus Autofluorescence (FAF) imaging data by a central reading center.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 n=3 Participants Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 n=6 Participants Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 n=12 Participants Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Change From Baseline in Geographic Atrophy (GA) Lesion Area Change from Baseline at Month 12	2.3 mm^2 Standard Deviation 1.9	1.6 mm^2 Standard Deviation NA NA: Standard deviation cannot be calculated for 1 participant.	2.5 mm^2 Standard Deviation 4.0	1.8 mm^2 Standard Deviation 0.8
Change From Baseline in Geographic Atrophy (GA) Lesion Area Baseline	13.5 mm^2 Standard Deviation 6.4	18.5 mm^2 Standard Deviation 10.6	9.4 mm^2 Standard Deviation 2.0	7.4 mm^2 Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Efficacy Population included all participants who received OpRegen in the study.

Change from baseline in visual acuity was measured by retro illuminated ETDRS chart from 4 meters distance. Visual acuity was reported as the number of letters read correctly.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 n=3 Participants Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 n=6 Participants Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 n=12 Participants Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Change From Baseline in Visual Acuity Change from Baseline at Month 12	15.7 number of letters Standard Deviation 34.2	3.0 number of letters Standard Deviation 8.7	-1.4 number of letters Standard Deviation 17.8	7.6 number of letters Standard Deviation 8.7
Change From Baseline in Visual Acuity Baseline	20.0 number of letters Standard Deviation 18.0	14.3 number of letters Standard Deviation 7.2	29.8 number of letters Standard Deviation 6.8	44.8 number of letters Standard Deviation 7.5

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Efficacy Population included all participants who received OpRegen in the study.

The NEI VFQ-25 is a 25 item patient-reported questionnaire. The composite score ranges from 0-100 with the higher score indicating better visual function.

Outcome measures

Outcome measures
Measure	Cohort 1 n=3 Participants Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 n=3 Participants Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 n=6 Participants Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 n=12 Participants Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Quality of Life Baseline	50.3 score on a scale Standard Deviation 15.3	42.9 score on a scale Standard Deviation 6.0	46.9 score on a scale Standard Deviation 18.8	62.2 score on a scale Standard Deviation 13.8
Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Quality of Life Change from Baseline at Month 12	5.1 score on a scale Standard Deviation 10.8	-5.7 score on a scale Standard Deviation 17.6	3.1 score on a scale Standard Deviation 18.2	3.7 score on a scale Standard Deviation 11.4

Adverse Events

Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 2

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 3

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 4

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort 1 n=3 participants at risk Participants in cohort 1 with Best Corrected Visual Acuity (BCVA) of 20/200 or less received a single subretinal delivery of the low dose of OpRegen on Day 0.	Cohort 2 n=3 participants at risk Participants in cohort 2 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 3 n=6 participants at risk Additional participants in cohort 3 with BCVA of 20/200 or less received a single subretinal delivery of the high dose of OpRegen on Day 0.	Cohort 4 n=12 participants at risk Participants in cohort 4 with BCVA of 20/64 to 20/250 received a single subretinal delivery of the high dose of OpRegen on Day 0.
Infections and infestations Respiratory tract infection	33.3% 1/3 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	33.3% 1/3 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	33.3% 1/3 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
General disorders Chest pain	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	33.3% 1/3 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Infections and infestations Cellulitis	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	33.3% 1/3 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Infections and infestations Pneumonia	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	33.3% 1/3 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Investigations Electrocardiogram change	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	33.3% 1/3 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	33.3% 1/3 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Eye disorders Retinal detachment	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	16.7% 1/6 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	8.3% 1/12 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	16.7% 1/6 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	16.7% 1/6 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/12 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	8.3% 1/12 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Endocrine disorders Hypercalcaemia	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	8.3% 1/12 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Eye disorders Macular fibrosis	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	8.3% 1/12 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	8.3% 1/12 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	8.3% 1/12 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Nervous system disorders Syncope	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	8.3% 1/12 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.
Vascular disorders Arterial thrombosis	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/3 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	0.00% 0/6 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.	8.3% 1/12 • Number of events 1 • From study start till 12 months following last subject dosed, plus up to 90 days (up to approximately 6.5 years) Safety Population included all participants who received OpRegen in the study.