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Completed

NCT Number: NCT02464956

Production of iPSC Derived RPE Cells for Transplantation in AMD

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.

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Key information

Conditions

Age Related Macular Degeneration (AMD) Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust

Other

Collaborators

  • Medical Research Council

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jun 8, 2015
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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