Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa
Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is the layer of tissue at the back of the inner eye that converts light images to nerve signals and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is used for this condition .
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Labeled Clinical Study to Evaluate the Safety and Efficacy OF Autologous Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Retinitis Pigmentosa.|
- visual acuity [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]Electronic Visual Acuity (EVA) technology
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
This study will involve about 8 visits over 1½ years .Each participant will be enrolled in study as per inclusion and exclusion criteria .Informed consent will be taken from subject before including in study. Subject will be underwent for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary outcome for this study will be a visual acuity score after one year of stem cell therapy .
Follow-up visits will be required regularly to determine the effectiveness of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in RP.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01914913
|Contact: Sachin P Jamadar, D.Orthoemail@example.com|
|Pune,, Maharashtra, India, 411030|
|Contact: Sachin P Jamadar, D ORTHO +918888788880 firstname.lastname@example.org|
|Principal Investigator: Anant E Bagul, MS,Ortho|
|Principal Investigator:||ANANT E BAGUL, MS ORTHO||Chaitanya Hospital|