The Safety and Tolerability of Sub-retinal Transplantation of SCNT-hES-RPE Cells in Patients With Advanced Dry AMD
NCT ID: NCT03305029
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
3 participants
INTERVENTIONAL
2016-05-31
2019-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SCNT-hES-RPE Cells
Pars plana vitrectomy and Sub-retinal Transplantation of Human Somatic cell nuclear transfer Embryonic Stem Cell Derived Retinal Pigmented Epithelial Cells (SCNT-hES-RPE Cells) in Patients with Advanced Dry Age-related Macular Degeneration(AMD)
SCNT-hES-RPE Cells
Pars Plana Vitrectomy and Sub-retinal Transplantation of Human Somatic cell nuclear transfer Embryonic Stem Cell Derived Retinal Pigmented Epithelial(SCNT-hES-RPE) Cells in Patients with Advanced Dry Age-related Macular Degeneration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SCNT-hES-RPE Cells
Pars Plana Vitrectomy and Sub-retinal Transplantation of Human Somatic cell nuclear transfer Embryonic Stem Cell Derived Retinal Pigmented Epithelial(SCNT-hES-RPE) Cells in Patients with Advanced Dry Age-related Macular Degeneration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment
3. Clinical findings consistent with advanced dry AMD with evidence of one or more areas of \>250 microns of geographic atrophy (as defined in the Age-Related eye Disease Study \[AREDS\] study) involving the central fovea.
4. GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
5. The visual acuity (BCVA) of the eye to receive the transplant will be no better than 20/200 in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity.
6. The visual acuity (BCVA) of the eye that is NOT to receive the transplant will be same or better than the eye to receive the transplant
7. Medically suitable to undergo vitrectomy and subretinal injection.
8. Medically suitable for general anesthesia or waking sedation, if needed.
9. If female and of childbearing potential, willing to medically acceptable methods of contraception during the study.
10. If male, willing to use barrier and spermicidal contraception during the study.
11. Willing to defer all future blood, blood component or tissue donation.
12. Able to understand and willing to sign the informed consent.
Exclusion Criteria
2. Presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy, other retinal vascular or degenerative disease other than ARMD, optic neuropathy, uveitis, intraocular inflammatory disease, retinal detachment repair or any other sight-threatening ocular disease.
3. Presence of glaucomatous optic neuropathy in the study eye, uncontrolled IOP, or use of two or more agents to control IOP (acetazolamide, beta blocker, alpha-1-agonist, prostaglandins, anhydrous carbonic inhibitors)
4. Cataract of sufficient severity likely to necessitate surgical extraction within 1 year.
5. Axial myopia of greater than -8 diopters.
6. Axial length greater than 28 mm.
7. Presence of significant lens opacities or other media opacity.
8. History of ocular lens removal within previous 3 months in the study eye.
9. History of ocular surgery in the study eye in the previous 3 months in the study eye.
10. History of malignancy or evidence of malignancy in screening test.
11. Medically not suitable for transplantation of an embryonic stem cell line: Any laboratory value which falls slightly outside of the normal range will be reviewed by the Medical Monitor and Investigators to determine its clinical significance. If it is determined not to be clinically significant, the patient may be enrolled into the study.
* History of drug abuse, identified in medical history taking.
* Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
* Any immunodeficiency.
* Negative cancer screening within previous 12 months: complete history \& physical examination; negative chest roentgenogram (CXR); negative blood test(including CBC \& manual differential); negative urinalysis (U/A); normal thyroid exam(T3, T4, TSH); if male, negative for prostate specific antigen (PSA); negative for upper gastrointestinal series or esophagogastroduodenoscopy; negative for α-fetoprotein(AFP); negative fecal occult blood test \& negative colonoscopy; if female, normal clinical breast exam and, negative mammogram, negative breast ultrasonography; if female, normal pelvic examination with Papanicolaou smear;
* Any of the below criteria of diabetes : Fasting blood glucose≥126mg/dl; random plasma glucose with typical symptoms of diabetes≥200mg/dl; HbA1c ≥ 7%
12. History of myocardial infarction or cerebrovascular accident in previous 12 months.
13. History of cognitive impairments or dementia which may impact the patients ability participate in the informed consent process and to appropriately complete evaluations.
14. Current participation in any other clinical trial.
15. Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
16. If female, pregnancy or lactation.
17. Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CHA University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Won Kyung, Song
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHA2015-08-141
Identifier Type: -
Identifier Source: org_study_id