Clinical Trial: Feasibility and Safety of Adult Human Bone Marrow-derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Feasibility and Safety of Adult Human Bone Marrow-Derived Mesenchymal Stem Cells by Intravitreal Injection in Patients With Retinitis Pigmentosa

Brief Summary: The purpose of this study is to determine the feasibility and safety of adult human bone marrow-derived mesenchymal stem cells by intravitreal injection in patients with retinitis pigmentosa.

Detailed Summary: Retinitis pigmentosa (RP) is an inherited disorder of the photoreceptor cells in the retina. Patients may lose vision since they were young or later in life. Currently, there are more than 60 genes identified as the cause of this condition, one of which, RPE65, has been studied in several gene therapy trials for Leber congenital amaurosis with promising results. Another treatment approach for RP is stem cell therapy. Studies in animal models of RP have shown that subretinal injection of bone marrow-derived mesenchymal stem cells may delay degenerative changes of photoreceptor cells.
Sponsor: Mahidol University

Current Primary Outcome: Change from baseline in laser flare and cell measurements [ Time Frame: up to 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change from baseline in visual function tests [ Time Frame: up to 12 months ]

Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: February 6, 2012
Date Started: February 2012
Date Completion:
Last Updated: February 8, 2012
Last Verified: February 2012