Treatment of Central Retinal Vein Occlusion Using Stem Cells Study

Study Eye Inclusion/Exclusion Criteria:

Inclusion criteria for the study eye:

• Clinical diagnosis of central retinal vein occlusion (CRVO) confirmed by review of medical records and screening assessment.
• Best Corrected Visual Acuity (BCVA) obtained during the screening period is in the range of 20/40+ to 20/400- (ETDRS letter score in the range of 18 to 73, inclusive).
• Duration of vision loss from CRVO >= 6 months to = 9 diopters)
• Amblyopia
• Other cause contributing to vision loss at screening.
• History of any of the following procedures: corneal transplant, glaucoma surgery, or intraocular silicone oil.

Participant-level Inclusion/Exclusion Criteria:

Participant-level inclusion criteria:

• Age >=18 years
• Female participants of child-bearing potential must not be pregnant or breastfeeding and have a negative urine pregnancy test within 14 days prior to sham injection and/or CD34+ cell injection.
• Females of childbearing potential must have had a hysterectomy, be completely abstinent from intercourse or must agree to practice effective contraception for the duration of the study. Acceptable methods of contraception include hormonal contraception, intrauterine device, barrier methods (diaphragm, condom) with spermicide, or surgical sterilization (tubal ligation).
• Able and willing to sign informed consent.
• Able to keep follow-up appointments for at least 12 months as determined by the investigator.

Participant-level exclusion criteria:

• Concurrent treatment with an investigational drug or device.
• Concurrent use of systemic immunosuppressive therapy or history of use within 3 months prior to enrollment (i.e., date ICF signed).
• Concurrent use of anticoagulation therapy except for aspirin without an acceptable safe stopping plan for study treatments.
• Known history of coagulopathy or other hematologic abnormality that may put participant at risk for bleeding or infection or raise concerns about quality or quantity of CD34+ cells isolated.
• History of allergy to fluorescein dye.
• Participant who has had a prior or concomitant malignancy with the exception of the following: 1) adequately treated basal or squamous cell carcinoma of the skin, or 2) any other malignancy from which the patient has remained disease free for more than five years.
• Current active systemic infection as evidenced by fever greater than 100.4 or any evidence of systemic infection as determined by the study physician.
• Any diagnosis of active infection or vaccination within 8 weeks of study treatment.
• Diabetes mellitus with known systemic complications by self-report or physician-determined by medical history or examination.
• History of prior radiotherapy to head/neck area.
• Poorly controlled hypertension with systolic > 180 or diastolic > 95.
• Serious medical or psychiatric condition that, in the opinion of the Investigator, would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study.
• Any physical characteristic that precludes ability to perform study diagnostic testing.