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Stem Cell Therapy
Stem Cell Therapy for Central Retinal Vein Occlusion (TRUST Trial)
Phase 1 & 2
Waitlist Available
Led By Susanna S Park, MD, PhD
Research Sponsored by The Emmes Company, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
TRUST Trial Summary
This trial is testing whether a stem cell therapy can improve vision in people with central retinal vein occlusion. Half the participants will receive the therapy immediately, and the other half will receive it 6 months later.
Eligible Conditions
- Central Retinal Vein Occlusion
TRUST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the Stem Cell Therapy
Incidence and Severity of Ocular and Systemic Adverse Events
Secondary outcome measures
Change in % Reduced Sensitivity
Change in Area of Non-perfusion within ETDRS Grid
Change in Area of Non-perfusion within Networc Grid
+17 moreTRUST Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Immediate Cellular Therapy / Deferred Sham TherapyActive Control2 Interventions
At baseline: Bone marrow aspiration followed by intravitreal injection of CD34+ cells.
At 6 months: Sham bone marrow aspiration and sham intravitreal injection.
Group II: Immediate Sham Therapy / Deferred Cellular TherapyPlacebo Group2 Interventions
At baseline: Sham bone marrow aspiration followed by sham intravitreal injection.
At 6 months: Bone marrow aspiration followed by intravitreal injection of CD34+ cells.
Find a Location
Who is running the clinical trial?
University of California, DavisOTHER
910 Previous Clinical Trials
4,706,975 Total Patients Enrolled
National Eye Institute (NEI)NIH
546 Previous Clinical Trials
1,401,912 Total Patients Enrolled
The Emmes Company, LLCLead Sponsor
145 Previous Clinical Trials
1,051,475 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It seems like the criteria "Study Eye Inclusion" is incomplete. Can you please provide more information or context for me to assist you accurately?You have had radiation treatment to your head or neck area in the past.Your high blood pressure is not well controlled, and it is very high.Your vision, with the help of glasses or contacts, falls within a certain range on a standard eye chart.You have had an allergic reaction to fluorescein dye in the past.You have been diagnosed with a specific eye condition called central retinal vein occlusion (CRVO).You currently have or have had ongoing eye inflammation in the past.You have had an eye injury that is affecting your vision right now.You have an eye infection that is not caused by the herpes virus and was diagnosed within the past 8 weeks.You have glaucoma that needs to be treated with more than 2 medications, laser, or surgery inside the eye.Lazy eyeSomething else is causing you to have trouble seeing during the screening.You have had surgery on your eyes such as corneal transplant, glaucoma surgery, or had silicone oil put in your eyes.You have a history of blood clotting or other blood problems that may raise concerns about the quality or quantity of isolated CD34+ cells.You have a cataract that is making it hard for you to see.Your lens or lens implant is not in the right position.You have new blood vessel growth in your eyes.You have severe nearsightedness (worse than -9 prescription).You have had an eye infection called ocular herpes at the same time as something else.You have an eye disease that could affect your vision during the study.You have swelling in the back of your eye that needs regular treatment, except for a specific type of medication given at least every 8 weeks.You have a condition, like cataracts or cloudy vitreous, that makes it hard for the doctor to see inside your eye.You have experienced vision loss from CRVO for at least 6 months but no more than 42 months.You have had cancer in the past, except for certain types of skin cancer that were treated successfully, or if you have been cancer-free for more than five years.You have a fever or any signs of a serious infection.You had an infection or got a vaccine in the last 8 weeks.You have diabetes with serious complications confirmed by your doctor.You had eye treatment with certain medications or surgery within 6 months before the study or are expected to have this treatment during the study.If you need injections in your eyes to treat swelling, you are currently getting them more often than every 8 weeks, or you started getting these injections less than 24 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Cellular Therapy / Deferred Sham Therapy
- Group 2: Immediate Sham Therapy / Deferred Cellular Therapy
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does this clinical trial hope to achieve?
"The main aim of this 6-month clinical trial is to evaluate the feasibility of stem cell therapy. Secondary outcomes that will be measured include changes in non-perfusion areas within different grids, as well as the integrity of the foveal avascular zone."
Answered by AI
How many volunteers will be enrolled in this experiment?
"The listing on clinicaltrials.gov reveals that this trial is open for recruitment and has been since October 22nd, 2019. The study will take place at a single site and require 20 participants in total."
Answered by AI
Are there any current vacancies for this clinical trial?
"The study, which is still recruiting patients according to clinicaltrials.gov, was originally posted on October 22nd 2019. The listing was last updated on August 12th, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Department of Ophthalmology & Vision Science, University of California Davis Eye Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Most responsive sites:
- Department of Ophthalmology & Vision Science, University of California Davis Eye Center: < 24 hours
Average response time
- < 1 Day
Typically responds via
Phone Call
Email
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