Trial Outcomes & Findings for Treatment of Central Retinal Vein Occlusion Using Stem Cells Study (NCT NCT03981549)

Last Updated: 2024-12-02

Results Overview

The primary safety outcome will be assessed at month 6. Adverse events (AE) that occur during the first 6 months of the trial will be broken down by whether the AE occurred following the sham or cellular treatment to assess differences in the adverse event experience between the cellular and sham therapies.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Months 0 to 6

Results posted on

2024-12-02

Participant Flow

Participant milestones

Participant milestones
Measure	Immediate Cellular Therapy / Deferred Sham Therapy At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Overall Study STARTED	7	9
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Central Retinal Vein Occlusion Using Stem Cells Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	67.9 years STANDARD_DEVIATION 12.59 • n=5 Participants	62.7 years STANDARD_DEVIATION 12.62 • n=7 Participants	64.9 years STANDARD_DEVIATION 12.47 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	7 Participants n=5 Participants	7 Participants n=7 Participants	14 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Months 0 to 6

Population: Number of participants randomized

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Incidence and Severity of Ocular and Systemic Adverse Events Anaemia	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Arthralgia	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Arthropod bite	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Back pain	1 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Basal cell carcinoma	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Dizziness	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Fall	0 participants	3 participants
Incidence and Severity of Ocular and Systemic Adverse Events Neuralgia	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Osteoarthritis	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Cystoid macular oedema in study eye	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Dermatochalasis in study eye	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Dry eye in study eye	2 participants	4 participants
Incidence and Severity of Ocular and Systemic Adverse Events Eye irritation in study eye	5 participants	4 participants
Incidence and Severity of Ocular and Systemic Adverse Events Eye puritis in study eye	1 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Foreign body sensation in study eye	2 participants	3 participants
Incidence and Severity of Ocular and Systemic Adverse Events Meibomian gland dysfuntion in study eye	1 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Pain in extremity	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Palpitations	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Rectal haemorrhage	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Rib fracture	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Sciatica	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Upper respiratory tract infection	1 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events White blood cell count decreased	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Visual acuity reduced in study eye	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Visual impairment in study eye	2 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Altered visual depth perception in study eye	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Chalazion in study eye	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Eye pain in study eye	4 participants	2 participants
Incidence and Severity of Ocular and Systemic Adverse Events Ocular hyperaemia in study eye	3 participants	3 participants
Incidence and Severity of Ocular and Systemic Adverse Events Periorbital irritation in study eye	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Photopsia in study eye	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Presbyopia in study eye	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Swelling of eyelid in study eye	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Vision blurred in study eye	1 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Vitreous degeneration in study eye	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Vitreous detachment in study eye	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Vitreous floaters in study eye	6 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Cystoid macular oedema in fellow eye	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Visual impairment in fellow eye	1 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Vitreous floaters in fellow eye	1 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Abdominal pain upper	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Acarodermatitis	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Appendicitis	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Cholelithiasis	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Chronic kidney disease	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Epicondylitis	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Foot deformity	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Heat exhaustion	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Hypertension	2 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Immunisation reaction	1 participants	3 participants
Incidence and Severity of Ocular and Systemic Adverse Events Migraine	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Procedural pain	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Rash	0 participants	1 participants
Incidence and Severity of Ocular and Systemic Adverse Events Soft tissue mass	1 participants	0 participants
Incidence and Severity of Ocular and Systemic Adverse Events Squamous cell carcinoma of skin	1 participants	0 participants

PRIMARY outcome

Timeframe: Day 0 and Day 182

Population: All participants with successful bone marrow aspiration

Number of CD34+ cells isolated from the bone marrow aspirate and number of cells injected into the eye

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Feasibility of the Stem Cell Therapy Number of CD34+ cells isolated from the bone marrow aspirate (pre-release)	5.4 Number of cells in millions Standard Deviation 2.20	5.9 Number of cells in millions Standard Deviation 4.65
Feasibility of the Stem Cell Therapy Number of CD34+ cells injected into the eye (pre-release)	3.8 Number of cells in millions Standard Deviation 1.69	4.6 Number of cells in millions Standard Deviation 4.14

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with visual acuity letter score recorded at Month 6

Mean change from baseline of visual acuity letter score at Month 6. The measure is calculated by subtracting the baseline visual acuity letter score from the month 6 visual acuity letter score. The participant is refracted for best corrected vision, and then reads single letters from the ETDRS charts using a visual acuity light box at a 4 meter distance (or 1 meter for participants with sufficiently reduced vision) according to a specific algorithm. A letter score is provided that ranges from 0 (unable to read any letters) to 100. A visual acuity letter score of 85 corresponds to a visual acuity of 20/20 as a Snellen equivalent. Higher is better.

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score	1.7 Letters read Standard Deviation 3.82	2.1 Letters read Standard Deviation 10.98

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with reduced sensitivity recorded at Month 6

Mean change from baseline of % reduced sensitivity at Month 6 as measured by microperimetry (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in % Reduced Sensitivity	0.8 percent reduced Standard Deviation 14.00	-11.4 percent reduced Standard Deviation 16.81

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with average threshold recorded at Month 6

Mean change from baseline of average threshold (dB) at Month 6 as measured by microperimetry (increase is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Average Threshold	-1.2 dB Standard Deviation 2.99	0.0 dB Standard Deviation 3.83

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal amplitude for ERG+OP a-wave under scotopic conditions recorded at Month 6

Mean change from baseline of percent of normal amplitude for ERG+OP a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=8 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Amplitude for ERG+OP (Oscillatory Potential) A-wave Under Scotopic Conditions	-7.7 percent normal amplitude Standard Deviation 36.84	18.6 percent normal amplitude Standard Deviation 18.15

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal amplitude for ERG+OP b-wave under scotopic conditions recorded at Month 6

Mean change from baseline of percent of normal amplitude for ERG+OP b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=8 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Amplitude for ERG+OP B-wave Under Scotopic Conditions	-8.4 percent normal amplitude Standard Deviation 48.94	11.6 percent normal amplitude Standard Deviation 22.50

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal latency for a-wave under scotopic conditions recorded at Month 6

Mean change from baseline of percent normal latency of ERG+OP a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=8 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Latency of ERG+OP A-wave Under Scotopic Conditions	1.3 percent normal latency Standard Deviation 21.59	-9.0 percent normal latency Standard Deviation 8.33

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal latency of ERG+OP b-wave under scotopic conditions recorded at Month 6

Mean change from baseline of percent normal latency of ERG+OP b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=8 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Latency of ERG+OP B-wave Under Scotopic Conditions	12.7 percent normal latency Standard Deviation 42.38	-1.2 percent normal latency Standard Deviation 24.95

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal amplitude for a-wave under photopic conditions recorded at Month 6

Mean change from baseline of percent normal amplitude for a-wave under photopic conditions at Month 6 as measured by Full-field ERG (increase is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Amplitude for A-wave Under Photopic Conditions	6.2 percent normal amplitude Standard Deviation 35.84	26.8 percent normal amplitude Standard Deviation 79.01

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal amplitude for b-wave under photopic conditions recorded at Month 6

Mean change from baseline of percent normal amplitude for b-wave under photopic conditions at Month 6 as measured by Full-field ERG (increase is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Amplitude for B-wave Under Photopic Conditions	-2.5 percent normal amplitude Standard Deviation 21.83	-6.0 percent normal amplitude Standard Deviation 22.83

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal latency for a-wave under photopic conditions recorded at Month 6

Mean change from baseline of percent normal latency for a-wave under photopic conditions at Month 6 as measured by Full-field ERG (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Latency for A-wave Under Photopic Conditions	-3.5 percent normal latency Standard Deviation 20.19	-0.0 percent normal latency Standard Deviation 13.08

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal latency for b-wave under photopic conditions recorded at Month 6

Mean change from baseline of percent normal latency for b-wave under photopic conditions at Month 6 as measured by Full-field ERG (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Latency for B-wave Under Photopic Conditions	-0.1 percent normal latency Standard Deviation 10.26	-4.7 percent normal latency Standard Deviation 7.59

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal flicker amplitude recorded at Month 6

Mean change from baseline in percent normal flicker amplitude at Month 6 as measured by Full-field ERG (increase is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Flicker Amplitude	-10.8 percent normal flicker amplitude Standard Deviation 14.10	2.2 percent normal flicker amplitude Standard Deviation 15.08

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with latency trough recorded at Month 6

Mean change from baseline of latency trough at Month 6 as measured by Full-field ERG (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Flicker Latency Trough	-4.2 percent latency trough Standard Deviation 8.92	-0.3 percent latency trough Standard Deviation 8.12

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal amplitude for a-wave under scotopic conditions recorded at Month 6

Mean change from baseline of percent normal amplitude for a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Amplitude for A-wave Under Scotopic Conditions	8.2 percent normal amplitude Standard Deviation 42.65	3.8 percent normal amplitude Standard Deviation 48.29

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal latency of a-wave under scotopic conditions recorded at Month 6

Mean change from baseline of percent normal latency of a-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Latency of A-wave Under Scotopic Conditions	12.4 percent normal latency Standard Deviation 56.19	-14.7 percent normal latency Standard Deviation 24.81

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal amplitude for b-wave under scotopic conditions recorded at Month 6

Mean change from baseline of percent normal amplitude for b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (increase is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Amplitude for B-wave Under Scotopic Conditions	-1.7 percent normal amplitude Standard Deviation 35.75	19.2 percent normal amplitude Standard Deviation 34.67

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with normal latency for b-wave under scotopic conditions recorded at Month 6

Mean change from baseline of percent normal latency for b-wave under scotopic conditions at Month 6 as measured by Full-field ERG (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Percent Normal Latency for B-wave Under Scotopic Conditions	-4.9 percent normal latency Standard Deviation 12.32	-5.7 percent normal latency Standard Deviation 14.47

SECONDARY outcome

Timeframe: 6 months

Population: All participants with integrity of the foveal avascular zone recorded at Month 6

Number of study eyes in each of the following categories as it relates to the integrity of the foveal avascular zone: Intact, Questionable, Disrupted (\<900 microns), Disrupted (900-1800 microns), Disrupted (\>1800 microns), and Cannot grade. Measured at Month 6 by fluorescein angiogram

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=9 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Baseline · Disrupted (900-1800 microns)	1 Participants	4 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Baseline · Disrupted (>1800 microns)	3 Participants	0 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Baseline · Cannot grade	0 Participants	0 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Month 6 · Intact	0 Participants	2 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Month 6 · Questionable	2 Participants	0 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Month 6 · Disrupted (<900 microns)	2 Participants	2 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Month 6 · Disrupted (900-1800 microns)	2 Participants	4 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Baseline · Intact	0 Participants	1 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Baseline · Questionable	2 Participants	2 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Baseline · Disrupted (<900 microns)	1 Participants	2 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Month 6 · Disrupted (>1800 microns)	1 Participants	0 Participants
Foveal Avascular Zone Integrity Foveal Avascular Zone Integrity at Month 6 · Cannot grade	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with area of non-perfusion within ETDRS grid recorded at Month 6

Mean change from baseline of area of non-perfusion within ETDRS grid at Month 6 as measured by fluorescein angiogram (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=7 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=8 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Area of Non-perfusion Within ETDRS Grid	1.4 mm^2 Standard Deviation 2.54	-3.3 mm^2 Standard Deviation 6.32

SECONDARY outcome

Timeframe: Months 0 to 6

Population: All participants with area of non-perfusion within Networc grid recorded at Month 6

Mean change from baseline of area of non-perfusion within Networc grid at Month 6 as measured by fluorescein angiogram (decrease is better)

Outcome measures

Outcome measures
Measure	Immediate Cellular Therapy / Deferred Sham Therapy n=6 Participants At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy n=5 Participants At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Change in Area of Non-perfusion Within Networc Grid	0.2 mm^2 Standard Deviation 152.70	28.0 mm^2 Standard Deviation 53.61

Adverse Events

Immediate Cellular Therapy / Deferred Sham Therapy: Months 0-6

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Immediate Sham Therapy / Deferred Cellular Therapy: Months 0-6

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Immediate Cellular Therapy / Deferred Sham Therapy: Months 6-12

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Immediate Sham Therapy / Deferred Cellular Therapy: Months 6-12

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Immediate Cellular Therapy / Deferred Sham Therapy: Months 0-6 n=7 participants at risk Data for Month 0 through Month 6. Treatment arms defined as follows. At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy: Months 0-6 n=9 participants at risk Data for Month 0 through Month 6. Treatment arms defined as follows. At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Cellular Therapy / Deferred Sham Therapy: Months 6-12 n=7 participants at risk Data for Month 6 through Month 12. Treatment arms defined as follows. At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. At 6 months: Sham bone marrow aspiration and sham intravitreal injection. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye	Immediate Sham Therapy / Deferred Cellular Therapy: Months 6-12 n=9 participants at risk Data for Month 6 through Month 12. Treatment arms defined as follows. At baseline: Sham bone marrow aspiration followed by sham intravitreal injection. At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells. Autologous Bone Marrow CD34+ Stem Cells: Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure. Sham Therapy: Sham bone marrow aspiration procedure that penetrates the skin, but does not penetrate the bone followed by sham intravitreal injection without penetration of the eye
Infections and infestations Appendicitis	0.00% 0/7 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	11.1% 1/9 • Number of events 1 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	0.00% 0/7 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	0.00% 0/9 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.
Eye disorders Vitreous haemorrhage	0.00% 0/7 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	0.00% 0/9 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	14.3% 1/7 • Number of events 1 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	0.00% 0/9 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.
Eye disorders Iris Neovascularization	0.00% 0/7 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	0.00% 0/9 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	14.3% 1/7 • Number of events 1 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.	0.00% 0/9 • Baseline to Month 12 The safety of the intravitreal injection of autologous CD34+ cells was assessed through regular eye examinations during the 12 month follow-up period. Adverse events (AEs) including new or worsening ocular conditions that occured from the time the participant signed informed consent until the final study visit were recorded, regardless of suspected cause. An AE and/or serious adverse event form was completed and the information was entered into the study electronic data capture system.

Other adverse events

Additional Information

Principal Investigator of the TRUST Data Coordinating Center

The Emmes Company, LLC

Phone: 301-251-1161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place