15 Participants Needed

Stem Cells for Retinal Disease

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of California, Davis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.26789

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.2481011

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.

Research Team

Ss

Susanna s Park, MD PhD

Principal Investigator

University of California Davis Eye Center

Eligibility Criteria

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.
See 8 more

Exclusion Criteria

Allergy to fluorescein dye
I have an eye condition affecting my vision.

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Stem cell treatedExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials
958
Recruited
4,816,000+

References

Adenovirally transduced bone marrow stromal cells differentiate into pigment epithelial cells and induce rescue effects in RCS rats. [2012]
Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. [2022]
Differentiation of human bone marrow-derived mesenchymal stem cells into neural-like cells by co-culture with retinal pigmented epithelial cells. [2021]
[Stem cells--new perspectives in the treatment of retinal disorders]. [2007]
Long-term survival of bone marrow-derived retinal nerve cells in the retina. [2019]
Long-term effects of intravitreal injection of GMP-grade bone-marrow-derived CD34+ cells in NOD-SCID mice with acute ischemia-reperfusion injury. [2021]
Bilateral Retinal Detachments After Intravitreal Injection of Adipose-Derived 'Stem Cells' in a Patient With Exudative Macular Degeneration. [2018]
Stem cells for retinal repair. [2014]
Stem Cells for Retinal Disease: A Perspective on the Promise and Perils. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
Intravitreal Administration of Human Bone Marrow CD34+ Stem Cells in a Murine Model of Retinal Degeneration. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Mertk gene expression and photoreceptor outer segment phagocytosis by cultured rat bone marrow mesenchymal stem cells. [2018]
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