Clinical Trial of Autologous Intravitreal Bone-marrow CD34+ Stem Cells for 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.
Dry Age-related Macular Degeneration
Retina Vein Occlusion
Drug: CD34+ bone marrow stem cells intravitreal
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Incidence and severity of ocular adverse events [ Time Frame: 1 day to 6 months ] [ Designated as safety issue: Yes ]As evident on eye examination by severe decrease in vision and/or adverse effect requiring major treatment intervention directly attributable to study treatment.
- The number of stem cells isolated and injected into the study eye [ Time Frame: 1 day ] [ Designated as safety issue: No ]Will determine the yield of the bone marrow aspiration and stem cell isolation procedures.
- Incidence and severity of systemic adverse events [ Time Frame: 1 day to 6 months ] [ Designated as safety issue: Yes ]Any systemic adverse event attributable to the bone marrow aspiration or intravitreal injection of the stem cells.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Experimental: Stem cell treated||Drug: CD34+ bone marrow stem cells intravitreal|
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.
|Contact: Susanna S Park, MD PhDfirstname.lastname@example.org|
|Contact: Marisa Salvadoremail@example.com|
|United States, California|
|University of California Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Sub-Investigator: Lawrence S Morse, MD PhD|
|Sub-Investigator: Jan Nolta, PhD|
|Sub-Investigator: Gerhard Bauer|
|Sub-Investigator: Carol Richman, MD|
|Sub-Investigator: Mehrdad Abedi, MD|
|Sub-Investigator: Douglas Taylor, MD|
|Principal Investigator:||Susanna s Park, MD PhD||University of California Davis Eye Center|