Stem Cells for Retinal Disease

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Davis

Must not be taking: Immunosuppressive therapy

Disqualifiers: Allergy to fluorescein, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on immunosuppressive therapy.

Is the use of CD34+ bone marrow stem cells for retinal disease safe?

Preliminary findings from a phase 1 clinical trial suggest that using CD34+ bone marrow stem cells for retinal conditions is generally safe, as these cells help repair damaged tissue. However, there have been reports of serious complications, such as retinal detachments, with other types of stem cell treatments, highlighting the importance of conducting these treatments under proper medical supervision. ^{1 2 3 4 5}

How is the CD34+ bone marrow stem cell treatment different from other treatments for retinal disease?

The CD34+ bone marrow stem cell treatment is unique because it involves injecting stem cells directly into the eye to help repair damaged retinal tissue, which is different from other treatments that may not directly target tissue repair. This approach uses the body's own cells to potentially slow down or reverse retinal damage, offering a novel method compared to traditional therapies. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment CD34+ bone marrow stem cells for retinal disease?

Research shows that CD34+ bone marrow stem cells can help repair damaged tissue, and early trials suggest they might be safe and feasible for treating retinal conditions. Animal studies and preliminary human trials provide hope that these stem cells could be used to treat retinal injuries. ^{1 6 9 10 11}

Who Is on the Research Team?

Susanna s Park, MD PhD

Principal Investigator

University of California Davis Eye Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Visual acuity 20/100 to CF

I am older than 18 years.

I have vision loss due to a specific eye condition.

Exclusion Criteria

Allergy to fluorescein dye

I have an eye condition affecting my vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Serial comprehensive eye examinations with retinal imaging and diagnostic tests

What Are the Treatments Tested in This Trial?

Interventions

• CD34+ bone marrow stem cells

Trial Overview 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.

How Is the Trial Designed?

Group I: Stem cell treated Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Adenovirally transduced bone marrow stromal cells differentiate into pigment epithelial cells and induce rescue effects in RCS rats. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Differentiation of human bone marrow-derived mesenchymal stem cells into neural-like cells by co-culture with retinal pigmented epithelial cells. [2021]

4. Poland pubmed.ncbi.nlm.nih.gov

[Stem cells--new perspectives in the treatment of retinal disorders]. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Long-term survival of bone marrow-derived retinal nerve cells in the retina. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Long-term effects of intravitreal injection of GMP-grade bone-marrow-derived CD34+ cells in NOD-SCID mice with acute ischemia-reperfusion injury. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Bilateral Retinal Detachments After Intravitreal Injection of Adipose-Derived 'Stem Cells' in a Patient With Exudative Macular Degeneration. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Stem cells for retinal repair. [2014]

9. United States pubmed.ncbi.nlm.nih.gov

Stem Cells for Retinal Disease: A Perspective on the Promise and Perils. [2017]

10. United States pubmed.ncbi.nlm.nih.gov

Intravitreal Administration of Human Bone Marrow CD34+ Stem Cells in a Murine Model of Retinal Degeneration. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Mertk gene expression and photoreceptor outer segment phagocytosis by cultured rat bone marrow mesenchymal stem cells. [2018]