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Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Human Embryonic Stem Cells

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ClinicalTrials.gov Identifier: NCT03046407
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
Qi Zhou, Chinese Academy of Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Biological: retinal pigment epithelium transplantation Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: Open Label
Primary Purpose: Other
Official Title: Treatment of Dry Age Related Macular Degeneration Disease With Retinal Pigment Epithelium Derived From Human Embryonic Stem Cells
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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).
Biological: 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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Efficacy:Early treatment of diabetic retinopathy eye chart (ETDRs) [ Time Frame: 12 months ]
    Visual function measure: change in visual acuity

  2. Efficacy:Best corrected visual acuity(BCVA) [ Time Frame: 12 months ]
    Visual function measure: change in visual acuity

  3. Efficacy:Optical coherent tomography (OCT) [ Time Frame: 12 months ]
    Visual function measure

  4. Efficacy:fundus autofluorescence [ Time Frame: 12 months ]
    Transplant and host retina integrity and survival

  5. Efficacy:vision inspection [ Time Frame: 12 months ]
    Changes of judgment after transplantation of patient's visual field



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03046407


Contacts
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Contact: Wang Liu, Doctor +86-01064807858 wangliu@ioz.ac.cn
Contact: Hao Jie, Doctor +86-01062558737 haojie@ioz.ac.cn

Locations
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China, Henan
The first affiliated hospital of Zhengzhou university Recruiting
Zhengzhou, Henan, China, 450052
Contact: Wan guang ming, Doctor    0371-66862213    wgm6608@163.com   
Contact: Li fu zhen, Doctor    0371-66862213    fuzhenlii@qq.com   
Sponsors and Collaborators
Chinese Academy of Sciences
The First Affiliated Hospital of Zhengzhou University
Investigators
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Principal Investigator: Zhou Qi, Doctor Institute of zoology, Chinese Academy of Sciences

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Responsible Party: Qi Zhou, Deputy director of Institute of zoology, chinese academy of sciences, and vice president of medical school, University of chinese academy of sciences, Chinese Academy of Sciences
ClinicalTrials.gov Identifier: NCT03046407     History of Changes
Other Study ID Numbers: ChineseASZQ-004
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases