- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03046407
Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Human Embryonic Stem Cells
January 30, 2018 updated by: Qi Zhou, Chinese Academy of Sciences
This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD).And we will assess the safety and efficacy of RPE transplants to treat dry AMD.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This project intends to transplant human embryonic stem cells derived retinal pigment epitheliums into subretinal space of patients to treat dry age-related macular degeneration(dry-AMD).
Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the safety and efficacy of RPE transplants to treat dry AMD.
Study Type
Interventional
Enrollment (Anticipated)
10
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
-
-
Henan
-
Zhengzhou, Henan, China, 450052
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
-
Contact:
- Wan guang ming, Doctor
- Phone Number: 0371-66862213
- Email: wgm6608@163.com
-
Contact:
- Li fu zhen, Doctor
- Phone Number: 0371-66862213
- Email: fuzhenlii@qq.com
-
-
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
55 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 55-80 years;
- Clinical diagnosis is consistent with the definition of late dry AMD in the age-related eye disease study (AREDS) (with one or more >250 micron geographic atrophy in the fovea;
- No CNV;
- The BCVA of target eye will not be better than 20/200;
- -8.00D<diopter<+8.00D,21mm<axis oculi≤28mm;
- voluntary as test subjects, signed informed consent, regular follow-up on time.
Exclusion Criteria:
- The macular atrophy caused by other diseases in addition to AMD;
- Suffer from retinitis pigmentosa, choroidal retinitis, central serous chorositis, diabetic retinopathy or other retinal vascular and degenerative diseases besides AMD;
- Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy and other ocular history;
- Other intraocular surgery history besides cataract surgery;
- In the last 6 months, there were severe heart failure (New York Heart Association grade III and IV) or the left ventricular ejection fraction <35% in any examinations
- One of the following circumstances: (1) dialysis or eGFR<20ml/min/1.73m2; (2) urinary protein / urinary creatinine is ≥1g/g; (3) creatinine or albumin / urinary creatinine is ≥600mg/g;
- Chronic liver disease, ALT increased >3 times normal value of the upper limit;
- Combined with other serious systemic diseases, such as cor pulmonale, severe COPD (FEV1%<50%) and so on;
- Combined with severe infectious diseases (such as HIV, syphilis antibody positive, etc;
- The quantitative detection of HCV-RNA was positive, the quantitative detection of HBV-DNA was greater than 103 IU/ml, and tuberculosis was in the contagious period, etc;
- Patients who are using anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days(The results of VerifyNow test show that AUC is greater than 470 and PRU is more than 208);
- Abnormal blood coagulation function or other obvious abnormal laboratory test results;
- Malignant tumor and history of malignant tumor;
- Women who are pregnant,prepare to be pregnant during the trial, be lactating;men who prepare to have baby during the trial;
- Any immune deficiency;
- Glucocorticoids or immunosuppressive drugs have been used in the last 3 months;
- Antipsychotic drugs have been used in the last 3 months, such as antidepressants, antipsychotic drugs, and so on;
- With hypersensitivity to tacrolimus or other macrolides;
- The history of addiction to alcoholism or prohibited drugs;
- Being participating in any intervention clinical trials;
- Poor compliance, difficult to complete the study;
- The person who did not receive the informed consent;
- Some researchers believe that there may be situations that can increase risks of the subjects or interfere clinical trials (for example, patients are prone to mental stress, depression, mental disorders, cognitive dysfunction, etc.).
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: retinal pigment epithelium transplantation
transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
|
Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety and tolerance of transplantation
Time Frame: 12 months
|
The safety and tolerance of transplantation of hESC-derived RPE will be considered safe: no above moderate adverse events or severe adverse events which related to transplantation of retinal pigment epithelial cells ; Cells without infectious; No tumorigenicity.
Through the clinical signs of subjects and laboratory examination to judge the tolerance, integrity, repellency of RPE cells, and monitoring the presence of local or systemic infection, and presence of metastatic tumor cells.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs)
Time Frame: 12 months
|
Visual function measure: change in visual acuity
|
12 months
|
Efficacy:Best corrected visual acuity(BCVA)
Time Frame: 12 months
|
Visual function measure: change in visual acuity
|
12 months
|
Efficacy:Optical coherent tomography (OCT)
Time Frame: 12 months
|
Visual function measure
|
12 months
|
Efficacy:fundus autofluorescence
Time Frame: 12 months
|
Transplant and host retina integrity and survival
|
12 months
|
Efficacy:vision inspection
Time Frame: 12 months
|
Changes of judgment after transplantation of patient's visual field
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
September 6, 2017
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
December 1, 2020
Study Registration Dates
First Submitted
February 2, 2017
First Submitted That Met QC Criteria
February 6, 2017
First Posted (Estimate)
February 8, 2017
Study Record Updates
Last Update Posted (Actual)
January 31, 2018
Last Update Submitted That Met QC Criteria
January 30, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChineseASZQ-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Dry Age-related Macular Degeneration
-
Luxa Biotechnology, LLCNational Eye Institute (NEI); National Institutes of Health (NIH); Regenerative...RecruitingDry Age-related Macular DegenerationUnited States
-
CHABiotech CO., LtdTerminatedDry Age Related Macular DegenerationKorea, Republic of
-
Smilebiotek Zhuhai LimitedActive, not recruitingDry Age-related Macular DegenerationUnited States
-
Chinese Academy of SciencesBeijing Tongren HospitalUnknownDry Age-related Macular DegenerationChina
-
Apheresis Research InstituteCompletedDry Age Related Macular DegenerationGermany
-
i-Lumen Scientific, Inc.WithdrawnDry Age-related Macular Degeneration
-
CHA UniversityUnknownDry Age Related Macular DegenerationKorea, Republic of
-
LumiThera, Inc.RecruitingDry Age-related Macular DegenerationNorway
-
LumiThera, Inc.National Eye Institute (NEI)RecruitingDry Age-related Macular DegenerationUnited States
-
Sucampo Pharma Americas, LLCSucampo Pharmaceuticals, Inc.CompletedDry Age-related Macular DegenerationAustria
Clinical Trials on retinal pigment epithelium transplantation
-
Chinese Academy of SciencesBeijing Tongren HospitalUnknownDry Age-related Macular DegenerationChina
-
Centre d'Etude des Cellules SouchesActive, not recruitingRetinitis PigmentosaFrance
-
Qi ZhouBeijing Tongren HospitalUnknown
-
University Hospital Inselspital, BerneTerminatedAge-related Macular Degeneration | Macular Edema | Retinal Vein Occlusion | Central Serous Chorioretinopathy | Retinal NeovascularizationSwitzerland
-
Shanghai General Hospital, Shanghai Jiao Tong University...Eyecure Therapeutics Inc.UnknownDegenerative Myopia With Macular Hole
-
Eyecure Therapeutics Inc.Beijing Tongren HospitalUnknownLeber Congenital Amaurosis, Retinitis PigmentosaChina
-
The First Affiliated Hospital with Nanjing Medical...UnknownMacular Degeneration | Age Related Macular Degeneration | AMDChina
-
Astellas Institute for Regenerative MedicineEnrolling by invitationMacular Degenerative DiseaseUnited Kingdom, United States
-
Singapore National Eye CentreSingapore Eye Research InstituteSuspended
-
Hospices Civils de LyonRecruitingTotal Bilateral Limbal Cell DeficiencyFrance