Clinical Trial: Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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. It is Self Fu

Brief Summary: 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 .

Detailed Summary:

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.


Sponsor: Chaitanya Hospital, Pune

Current Primary Outcome: visual acuity [ Time Frame: 1 YEAR ]

Electronic Visual Acuity (EVA) technology


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Chaitanya Hospital, Pune

Dates:
Date Received: July 31, 2013
Date Started: September 2014
Date Completion: November 2016
Last Updated: September 16, 2014
Last Verified: September 2014