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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
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Moorfields Eye Hospital NHS Foundation Trust

Brief Summary:
No treatments exist for Age-related Macular Degeneration (AMD) when there is cell loss such as in late wet AMD or dry AMD. The differentiation of RPE cells from patient derived iPSC will offer valuable source of tissue for transplantation in these forms of AMD and may form basis for a future treatment option in terms of cell transplantation.

Condition or disease
Age Related Macular Degeneration (AMD)

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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
Peripheral blood sample and a skin sample will be collected from the study participants


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by Age Related Macular Degeneration (AMD)
Criteria

Inclusion Criteria:

  • Subjects over the age of 18 years
  • Subjects with the ability to give informed consent
  • Subjects with known AMD (both wet and dry)

Exclusion Criteria:

  • Unable to give informed consent
  • Subjects unable to give blood sample for medical reasons
  • Subjects with coagulopathies
  • Subjects who are known to be at risk of keloid scarring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464956


Contacts
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Contact: Panayiotis Panayiotou +44(0)2072533411 x 4652 panayiotis.panayiotou@moorfields.nhs.uk

Sponsors and Collaborators
Moorfields Eye Hospital NHS Foundation Trust
Medical Research Council

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Responsible Party: Moorfields Eye Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02464956     History of Changes
Other Study ID Numbers: DACL1011
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases