NCT01914913

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

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 Funded (Patients' Own Funding) Clinical Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Chaitanya Hospital, Pune · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 description

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.

Conditions

• Retinitis Pigmentosa

Interventions

Type	Name	Description
BIOLOGICAL	BMMNCs	Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-08-02
• Last updated: 2014-09-17

Locations

1 site across 1 country: India