Production of iPSC Derived RPE Cells for Transplantation in AMD
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|ClinicalTrials.gov Identifier: NCT02464956|
Recruitment Status : Unknown
Verified May 2015 by Moorfields Eye Hospital NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted : June 8, 2015
Last Update Posted : June 8, 2015
|Condition or disease|
|Age Related Macular Degeneration (AMD)|
It has been shown that adult human skin cells or human blood cells can be reprogrammed to become stem cells. This type of stem cell is called an induced Pluripotent Stem Cell (iPSC).It has been shown specifically that this type of stem cell can be produced from adult human skin cells or blood cells can in turn be converted into Retinal Pigment Epithelial (RPE) cells. These RPE cells are a very important cell type in the human retina that are abnormal and ultimately lost in Age-related Macular Degeneration (AMD). Although it has been shown to be possible to make RPE cells from adult human skin, it has not been done to a level to fulfil regulatory requirements for human transplantation in AMD.
This is a feasibility study involving 10 patients. The efficiency of creating an iPSC-Derived RPE cells from a patient's own skin or blood will be examined. A sample size of 10 patients will allow us to potentially consolidate the safety and efficacy of this method in order to create these cells within the context of a future transplantation trial.
|Study Type :||Observational|
|Estimated Enrollment :||10 participants|
|Official Title:||Feasibility of Production of Induced Pluripotent Stem Cell Derived Retinal Pigment Epithelial Cells Fulfilling Regulatory Requirements for Human Transplantation in Dry Age-related Macular Degeneration|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2016|
- Successful production of a Retinal Epithelial (RPE) layer that fulfils Regulatory Regulation for transplantation. This will be confirmed with standard laboratory characterisation of RPE and completed toxicity and safety studies on the cell layer. [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464956
|Contact: Panayiotis Panayiotou||+44(0)2072533411 x firstname.lastname@example.org|