A Study of Experimental Stem Cell Injection for Central Retinal Vein Occlusion (vision loss due to decreased blood supply in eye)

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"Volunteer for research at UC Davis Eye Center"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Central Retinal Vein Occlusion, Vision loss, Eye, Eye Center, Vein Occlusion, Retina
Type: Biological study, Phase [1, 2]
Target:
20 Participants
Investigator:
Description
Central retinal vein occlusion (CRVO) is an eye condition often associated with permanent loss of vision. CRVO blocks the blood supply to the retina. The retina is the part of the eye that captures the images that the eye sees and transmits the information to the brain. This blockage can damage your retina causing vision loss.

In this study, we aim to learn more about a new procedure that involves injecting your own (autologous) stem cells into the eye. This approach is investigational and we do not have a lot of information about it. However, this stem cell procedure was used in a smaller study of 9 patients with different eye diseases including 1 patient with CRVO. The study was conducted by the same team led by Dr. Susanna Park at UC Davis. The aim of the current larger study is to get more information about this new procedure for patients with vision loss from CRVO.

All participants will be randomly assigned to 1 of 2 groups. Both groups will receive one stem cell injection in the study eye. You will not be told which group you are in until the end of the study.

Group 1 will have a bone marrow aspiration and stem cell injection during Study Period 1 or at the beginning of the study. During Study Period 2 or around 6 months into the study, Group 1 will have a sham or fake aspiration and a sham or fake injection.

Group 2 will have a sham or fake aspiration and a sham or fake injection during Study Period 1 or at the beginning of the study. During Study Period 2 or around 6 months into the study, Group 2 will have bone marrow aspiration and stem cell injection.
This study requires

The study team will make sure you qualify to take part in the study. In order to determine if you qualify, the study team may ask you to send medical records from your Ophthalmologist and Primary Care Physician.

We expect that you will be in this research study for 24 months. You will be asked to visit the research site approximately 20 times. Please refer to the attached visit schedule for the timeline, number, and length of study appointments.

All study visits will take place in Sacramento, CA.

Travel expenses will be the responsibility of the participant.

Who can participate

This is a list of general criteria. The full list can be viewed by clicking the link to the ClinicalTrials.gov website.

Inclusion criteria for the study eye:

  • Clinical diagnosis of central retinal vein occlusion (CRVO)
  • Visual Acuity (BCVA) obtained during the screening period is in the range of 20/60+ to 20/400
  • Duration of vision loss from CRVO for less than 3 years.

Exclusion criteria for the study eye:

  • Previous eye treatment with intravitreal or periocular steroids, intravitreal injection, laser or intraocular surgery within 6 months prior to enrollment (i.e., date ICF signed) or treatment expected during the study period.
  • Glaucoma requiring treatment with more than 1 medication, laser or intraocular surgery.
  • Presence of cataract that is impairing vision.
  • History of ocular trauma that is currently impairing vision.
  • History or concurrent optic nerve or retinal disease, including macular degeneration, myopic degeneration, retinitis pigmentosa, retinal tear or detachment.
  • High myopia
  • History of any of the following procedures: corneal transplant, glaucoma surgery, photodynamic therapy, retinal cryopexy, pneumatic retinopexy, intraocular oil or scleral buckle.

Participant-level Inclusion

  • Age > 18 years of age.
  • 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 stem 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 to keep follow-up appointments for at least 24 months in Sacramento, CA.

Participant-level Exclusion

  • 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.
  • History of allergy to fluorescein dye.
  • Any diagnosis of active infection or vaccination within 8 weeks of study treatment.
  • Diabetes mellitus with known systemic complications.
  • History of prior radiotherapy to head/neck area.
  • Poorly controlled hypertension with systolic > 180 or diastolic > 95.
  • Any physical characteristic that precludes ability to perform study diagnostic testing.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
PDF Docs
TRUST Study Visit Schedule
Schedule
Study duration and period
We expect that you will be in this research study for 24 months. You will be asked to visit the research site approximately 20 times.
Recruitment period
From July 8, 2016 to Dec. 18, 2020
Location
UC Davis Eye Center
4860 Y Street
Suite 2400
Sacramento, CA 95817
Research Topic
Conditions:
  • Central Retinal Vein Occlusion

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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