Clinical trial NCT01736059: Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for Retinopathy
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
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
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2012-11-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* allergy to fluorescein dye
* other concurrent retinal or optic nerve disease affecting vision

Primary outcomes:
measure: Incidence and severity of ocular adverse events
timeFrame: 1 day to 6 months
Secondary outcomes:
measure: The number of stem cells isolated and injected into the study eye
timeFrame: 1 day
Other outcomes:
measure: Incidence and severity of systemic adverse events
timeFrame: 1 day to 6 months
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
Study officials:
affiliation: University of California Davis Eye Center
name: Susanna s Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Park 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.