University of California Davis
Sacramento, California, 95817, United States
NCT Number: NCT04925687
In this Phase 1 open-labeled prospective study, one eye of each participant with vision loss from retinitis pigmentosa will be administered intravitreal injection of autologous CD34+ stem cells harvested from bone marrow. Each participant will be examined serially for 6 months after study injection to determine safety and feasibility of this intervention.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Sacramento, California, 95817, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Autologous CD34+ cells harvested from bone marrow injected intravitreal
Time frame: 6 months
Number and severity of Ocular and systemic adverse events
Time frame: Baseline
Number of CD34+ cells harvested for intravitreal injection
Time frame: 6 months
Change in number of letters read in study eye from baseline
Time frame: 1 month
Change in number of letters read in study eye from baseline
Time frame: 6 months
Change in visual field area in study eye from baseline
Time frame: 1 month
Change in visual field area in study eye from baseline
Time frame: 6 months
Change in a and b wave amplitude in study eye from baseline
Time frame: 1 month
Change in a and b wave amplitude in study eye from baseline
Time frame: 6 months
Change in Vision Questionnaire compared to baseline
Time frame: 1 month
Change in Vision Questionnaire compared to baseline
Time frame: 6 months
Change in average threshold from baseline
Time frame: 6 months
Change percent reduced sensitivity from baseline
Time frame: 1 month
Change in average threshold from baseline
Time frame: 1 month
Change in percent reduced sensitivity from baseline
University of California, Davis
Other
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
Acronym: BMSCRP1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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