- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02749734
Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
January 29, 2018 updated by: ZhengQin Yin, Southwest Hospital, China
The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400038
- Southwest Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aging from 18 to 75 years
- must have signed informed consent
- At least one visually impaired eye caused by macular degeneration diseases
- Can not be effectively treated with conventional therapies
- Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)
- Visual loss caused by macular degeneration diseases
Exclusion Criteria:
- Eyes with concomitant diseases which will interfere the visual improvement of the study
- Active intraocular inflammation regardless of the grade of severity
- Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)
- History of uveitis
- Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction
- Iris neovascularization
- Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart)
- History of intraocular surgery
- Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis
- Allergic to sodium fluorescein
- Uncontrolled hypertension (systolic pressure>140mmHg,or diastolic pressure>90mmHg)
- Coagulative function disorder
- System administration of drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.
- Involved in other clinical trials of any medicine within 1 month (or within 5 half-life periods)
- Have maternity plan in 6 months
- In pregnancy or lactation period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hESC-RPE
Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums
|
Transplant hESC-RPE into subretinal space of patients with macular degeneration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]
Time Frame: up to 12 months
|
Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize
Time Frame: up to 12 months
|
Visual acuity is reflected by number of ETDR letters participants can recognize
|
up to 12 months
|
Visual Field as examined by Static perimetry
Time Frame: up to 12 months
|
Area and sensitivity of visual field are detected by Static perimetry
|
up to 12 months
|
Flash Electroretinogram (FERG)
Time Frame: up to 12 months
|
Retinal electrophysiological function is tested by FERG
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up to 12 months
|
Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)
Time Frame: up to 12 months
|
Optic nerve function as assessed by FVEP
|
up to 12 months
|
Multifocal Electroretinogram (MFERG)
Time Frame: up to 12 months
|
Local retinal function as assessed by MFERG
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
December 1, 2018
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
January 7, 2016
First Submitted That Met QC Criteria
April 20, 2016
First Posted (Estimate)
April 25, 2016
Study Record Updates
Last Update Posted (Actual)
January 31, 2018
Last Update Submitted That Met QC Criteria
January 29, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013CB967002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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