Non-exudative Age-related Macular DegenerationPhase 1NCT01736059
Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
A Phase 1 study testing CD34+ bone marrow stem cells intravitreal in people with Non-exudative Age-related Macular Degeneration and Diabetic Retinopathy, run by University of California, Davis at 1 site in United States.
Trial summary
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 are irreversibly blind from various retinal conditions. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-exudative Age-related Macular Degeneration, Diabetic Retinopathy, Retina Vein Occlusion
- What is being tested?
- CD34+ bone marrow stem cells intravitreal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18 years of age
- visual acuity 20/100 to CF
- duration of vision loss > 3 months
- vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy
- the study eye has the worse visual acuity
- no active eye or systemic disease
Show all 11Show fewer
- no history of macular edema or retinal/choroidal neovascularization requiring treatment within 6 months
- no significant media opacity
- no coagulopathy or other hematologic abnormality
- no concurrent immunosuppressive therapy
- able to keep follow-up for 6 months
Who cannot join
- allergy to fluorescein dye
- other concurrent retinal or optic nerve disease affecting vision
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis
Sacramento, California, 95817
About this study
Official title: A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy
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 are irreversibly blind from various retinal conditions.
Read the detailed description
In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.
- Conditions
- Non-exudative Age-related Macular Degeneration, Diabetic Retinopathy, Retina Vein Occlusion, Retinitis Pigmentosa, Hereditary Macular Degeneration
- Being tested
- CD34+ bone marrow stem cells intravitreal
- Keywords
- Stem cells, intravitreal, bone marrow CD34+ cells, retinal disease, clinical trial, autologous
- Medical subject headings
- Diabetic Retinopathy, Retinitis Pigmentosa, Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD34+ bone marrow stem cells intravitrealDrug
| Study group | Role | What they receive |
|---|---|---|
| Stem cell treated | Experimental | Not described Receives: Drug: CD34+ bone marrow stem cells intravitreal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of ocular adverse events
As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.
Measured: 1 day to 6 months
Secondary outcomes (1)
The number of stem cells isolated and injected into the study eye
Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-exudative Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanna s Park, MD PhD, Principal investigator, University of California Davis Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736059
- Sponsor's protocol ID
- 906595
- Other IDs
- BMSCRetPilot
- Status last verified
- Jan 2026
- First submitted
- 25 Jul 2012
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Once study is completed, the study findings will be published in peer reviewed publication for public access.
Publications
Park SS. Cell Therapy Applications for Retinal Vascular Diseases: Diabetic Retinopathy and Retinal Vein Occlusion. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(5):ORSFj1-ORSFj10. doi: 10.1167/iovs.15-17594.
PubMed 27116667Park SS, Bauer G, Abedi M, Pontow S, Panorgias A, Jonnal R, Zawadzki RJ, Werner JS, Nolta J. Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. Invest Ophthalmol Vis Sci. 2014 Dec 9;56(1):81-9. doi: 10.1167/iovs.14-15415.
PubMed 25491299
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial of the Feasibility and Safety of Intravitreal Autologous Adult Bone Marrow Stem Cells in Treating Eyes With Vision Loss From Retinopathy
- ClinicalTrials.gov ID
- NCT01736059
- Acronym / sponsor ID
- 906595
- Conditions
- Non-exudative Age-related Macular Degeneration, Diabetic Retinopathy, Retina Vein Occlusion, Retinitis Pigmentosa, Hereditary Macular Degeneration
- Keywords
- Stem cells, intravitreal, bone marrow CD34+ cells, retinal disease, clinical trial, autologous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 are irreversibly blind from various retinal conditions.
Detailed description
In this pilot clinical trial, eyes with irreversible vision loss from retinal degenerative conditions (macular degeneration or retinitis pigmentosa) or retinal vascular disease (diabetic retinopathy or retinal vein occlusion) will be treated with intravitreal injection of autologous CD34+ stem cells isolated from bone marrow aspirate under Good Manufacturing Practice conditions. This study will determine whether there are any major safety and feasibility concerns using this therapy. Patients will be followed for 6 months after treatment by serial comprehensive eye examination supplemented with various retinal imaging and diagnostic tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stem cell treated | Experimental | Drug: CD34+ bone marrow stem cells intravitreal |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- age >18 years of age
- visual acuity 20/100 to CF
- duration of vision loss > 3 months
- vision loss from macular degeneration, retinitis pigmentosa, retinal vein occlusion or diabetic retinopathy
- the study eye has the worse visual acuity
Key exclusion criteria (2 listed)
- allergy to fluorescein dye
- other concurrent retinal or optic nerve disease affecting vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD34+ bone marrow stem cells intravitreal | Drug | Stem cell treated |
Primary outcome
Incidence and severity of ocular adverse events
Time frame: 1 day to 6 months
As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.
1 secondary outcome
The number of stem cells isolated and injected into the study eye
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background: PubMed 27116667Park SS. Cell Therapy Applications for Retinal Vascular Diseases: Diabetic Retinopathy and Retinal Vein Occlusion. Invest Ophthalmol Vis Sci. 2016 Apr 1;57(5):ORSFj1-ORSFj10. doi: 10.1167/iovs.15-17594.
- Results publication: PubMed 25491299Park SS, Bauer G, Abedi M, Pontow S, Panorgias A, Jonnal R, Zawadzki RJ, Werner JS, Nolta J. Intravitreal autologous bone marrow CD34+ cell therapy for ischemic and degenerative retinal disorders: preliminary phase 1 clinical trial findings. Invest Ophthalmol Vis Sci. 2014 Dec 9;56(1):81-9. doi: 10.1167/iovs.14-15415.
- Learn more or sign up for the study here!Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once study is completed, the study findings will be published in peer reviewed publication for public access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanna s Park, MD PhD principal investigator
University of California Davis Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD34+ bone marrow stem cells intravitreal in people with Non-exudative Age-related Macular Degeneration and Diabetic Retinopathy, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of ocular adverse events (time frame: 1 day to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01736059, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.