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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02464956
Other study ID # DACL1011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2015
Est. completion date February 2019

Study information

Verified date September 2021
Source Moorfields Eye Hospital NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date February 2019
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 50 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Moorfields Eye Hospital NHS Foundation Trust Medical Research Council

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year
See also
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Enrolling by invitation NCT05481827 - ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study Phase 2
Completed NCT01542866 - A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD) N/A