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CompletedNCT02464956Updated Apr 12, 2022

Production of iPSC Derived RPE Cells for Transplantation in AMD

An observational study in Age Related Macular Degeneration (AMD), sponsored by Moorfields Eye Hospital NHS Foundation Trust. Completed. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-04-12.

Sponsored by Moorfields Eye Hospital NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
50 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Age Related Macular Degeneration (AMD)
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 3 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients affected by Age Related Macular Degeneration (AMD)

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02464956
Lead sponsor
Moorfields Eye Hospital NHS Foundation Trust
Collaborators
Medical Research Council
Responsible party
Sponsor
First posted
Jun 8, 2015
Start date
Dec 2015
Primary completion
Aug 2018
Completion
Feb 2019
Last update
Apr 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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