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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether CD34+ stem cells from bone marrow can safely aid individuals with permanent vision loss from certain retinal diseases. The goal is to determine if injecting these cells into the eye is safe and feasible. Individuals who have experienced vision loss for over three months due to conditions like macular degeneration or diabetic retinopathy, and have worse vision in one eye, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in humans, offering participants the chance to be among the first to receive this innovative therapy.

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 there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using CD34+ stem cells from bone marrow to treat eye diseases is generally safe. Studies have found that this type of stem cell therapy is well tolerated when injected into the eye. In earlier tests, patients with eye conditions did not experience any serious side effects after receiving the treatment. These studies primarily aimed to assess the safety and practicality of the treatment, and the results were promising. Although this is early research, the consistent findings suggest that the treatment does not cause major side effects and is considered practical.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for retinal diseases, which often focus on slowing vision loss through medications or procedures like laser therapy, CD34+ bone marrow stem cells offer a regenerative approach. These stem cells have the potential to repair and regenerate damaged retinal tissue, tackling the root cause of vision impairment rather than just managing symptoms. Researchers are excited about this treatment because it taps into the body's natural healing processes, offering hope for more effective, long-term restoration of vision.

What evidence suggests that CD34+ bone marrow stem cells might be an effective treatment for retinal disease?

Research shows that injecting certain stem cells from bone marrow into the eye may help people with retinal diseases. Previous studies have found this method possible and safe for patients with conditions like age-related macular degeneration and retinitis pigmentosa. In this trial, participants will receive CD34+ bone marrow stem cells to repair damaged parts of the eye, potentially improving vision or preventing further deterioration. Early results primarily focus on safety, but the concept is that these stem cells can repair the eye's cells. More research is needed to confirm its effectiveness, but the underlying science is promising.12346

Who Is on the Research Team?

Ss

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.
See 8 more

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?
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+

Citations

Intravitreal Autologous Bone Marrow CD34+ Cell Therapy for ...Intravitreal autologous BM CD34+ cell therapy appears feasible and well tolerated in eyes with ischemic or degenerative retinal conditions and merits further ...
Randomized Study of Intravitreal Autologous CD34+ Stem ...The primary study objective was to assess the safety and feasibility of the stem cell therapy as determined by the following outcome measures: ...
Phase I Study of Intravitreal Injection of Autologous CD34+ ...Purpose. To evaluate the feasibility and safety of intravitreal injection of autologous CD34+ stem cells from bone marrow (BMSCs) in eyes with ...
Study Details | NCT01736059 | Clinical Trial of Autologous ...This pilot study is to determine whether it would be safe and feasible to inject CD34+ stem cells from bone marrow into the eye as treatment for patients who ...
Cell therapy for retinal degenerative disorders: a systematic ...This meta-analysis aims to comprehensively evaluate the efficacy of cell therapy in treating age-related macular degeneration (AMD), retinitis pigmentosa (RP), ...
Phase 1 Study of Intravitreal Autologous CD34+ Stem Cell ...Phase 1 Study of the Feasibility and Safety of Intravitreal Autologous Bone Marrow CD34+ Stem Cell Therapy for Eyes With Vision Loss From Retinitis Pigmentosa.
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