What is the mechanism of action of this treatment?

The most common treatments for Diabetic Retinopathy include anti-VEGF injections, corticosteroids, laser therapy, and vitrectomy. Anti-VEGF injections work by inhibiting vascular endothelial growth factor, reducing abnormal blood vessel growth and leakage. Corticosteroids reduce inflammation and edema in the retina. Laser therapy seals leaking blood vessels and prevents further vision loss. Vitrectomy removes blood and scar tissue from the vitreous. These treatments are crucial as they help manage symptoms and prevent progression of the disease. Similar to these treatments, the CD34+ stem cell injection trial aims to repair or replace damaged retinal cells, offering a regenerative approach that could potentially restore vision and address the underlying damage caused by Diabetic Retinopathy.

What side effects are associated with this type of intervention?

Common treatments for diabetic retinopathy include anti-VEGF injections, corticosteroids, laser therapy, and vitrectomy. Anti-VEGF injections, such as aflibercept, can cause side effects like eye pain, vitreous floaters, and increased intraocular pressure. Corticosteroids, such as Ozurdex, may lead to cataract formation and elevated intraocular pressure. Laser therapy can result in peripheral vision loss and night vision difficulties. Vitrectomy, a surgical procedure, carries risks of retinal detachment and infection. Treatments similar to CD34+ stem cell injections, which aim to regenerate retinal cells, are still under investigation, but potential side effects could include immune reactions, infection, and unintended cell proliferation.

What prior FDA approvals exist?

The FDA has approved several treatments for Diabetic Retinopathy, primarily focusing on anti-VEGF (vascular endothelial growth factor) therapies such as ranibizumab (Lucentis), aflibercept (Eylea), and bevacizumab (Avastin). These drugs work by inhibiting the growth of abnormal blood vessels in the retina. While these treatments do not directly repair or replace damaged retinal cells, they help manage the condition and prevent further damage. Regenerative therapies like CD34+ stem cell injections, which aim to repair or replace damaged retinal cells, are still under investigation and have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to CD34+ stem cell injections for diabetic retinopathy include: 1) Aflibercept (Eylea), which has shown potential in improving macular thickness in patients previously treated with other anti-VEGF therapies like ranibizumab and bevacizumab. 2) Gene therapy approaches targeting specific molecular pathways involved in retinal damage. 3) Induced pluripotent stem cells (iPSCs) for generating patient-specific retinal cells. 4) Anti-angiogenic therapies targeting novel molecular targets beyond VEGF. These alternatives are in various stages of research and clinical trials, offering potential new avenues for treatment.

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Stem Cell Therapy

Stem Cells for Retinal Disease

Phase 1

Waitlist Available

Led By Susanna s Park, MD PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years of age

Vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion, or diabetic retinopathy

Must not have

Other concurrent retinal or optic nerve disease affecting vision

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if injecting special cells from bone marrow into the eye is safe and possible for patients who are permanently blind due to retinal diseases. The hope is that these cells can help fix the damaged parts of their eyes.

Who is the study for?

This trial is for adults over 18 with vision loss from conditions like macular degeneration or diabetic retinopathy. Participants must have a visual acuity ranging from 20/100 to hand movement and the affected eye should be the one with worse vision. They shouldn't have had certain eye treatments in the last 6 months, no blood disorders, active diseases, or be on immunosuppressive therapy.

What is being tested?

The study tests injecting CD34+ stem cells directly into the eye of patients who are blind due to various retinal diseases. It aims to assess if this approach is safe and can feasibly improve sight.

What are the potential side effects?

Potential side effects may include discomfort at injection site, inflammation inside the eye, increased intraocular pressure, bleeding, infection risk post-procedure and possible immune reaction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have vision loss due to a specific eye condition.

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I haven't had treatments for eye swelling or abnormal blood vessels in the eye in the last 6 months.

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I am not on any immunosuppressive therapy.

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I have had vision loss for more than 3 months.

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I do not have any active eye or systemic diseases.

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I do not have any blood clotting or blood disorders.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an eye condition affecting my vision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and severity of ocular adverse events

Secondary study objectives

The number of stem cells isolated and injected into the study eye

Other study objectives

Incidence and severity of systemic adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stem cell treatedExperimental Treatment1 Intervention

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Diabetic Retinopathy include anti-VEGF injections, corticosteroids, laser therapy, and vitrectomy. Anti-VEGF injections work by inhibiting vascular endothelial growth factor, reducing abnormal blood vessel growth and leakage. Corticosteroids reduce inflammation and edema in the retina. Laser therapy seals leaking blood vessels and prevents further vision loss. Vitrectomy removes blood and scar tissue from the vitreous. These treatments are crucial as they help manage symptoms and prevent progression of the disease. Similar to these treatments, the CD34+ stem cell injection trial aims to repair or replace damaged retinal cells, offering a regenerative approach that could potentially restore vision and address the underlying damage caused by Diabetic Retinopathy.