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Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa

Clinicaltrials.gov identifier NCT03944239

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted March 26, 2020

Study Description

Brief summary:

This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.

  • Condition or Disease:Retinitis Pigmentosa
  • Intervention/Treatment: Biological: Retinal pigment epitheliums transplantation
  • Phase: Phase 1
Detailed Description

This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 10 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Other
  • Official Title: Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
  • Estimated Study Start Date: May 2020
  • Estimated Primary Completion Date: October 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: retinal pigment epitheliums transplantation
Transplant clinical-grade hESC derived retinal pigment epitheliums into subretinal of patients with retinitis pigmentosa.The dosage is 150000.
Biological: Retinal pigment epitheliums transplantation
Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.
Outcome Measures
  • Primary Outcome Measures: 1. Adverse events and serious adverse events occurred within 1 year after transplantation [ Time Frame: one year ]
    The occurrence of adverse events (AE), severe adverse events (SAE), treatment-related adverse events (TEAE), and clinically significant vital signs during the study period.
  • Secondary Outcome Measures: 1. Improvement of visual function [ Time Frame: one year ]
    The changes of BCVA and EDTRS were observed one year after surgery.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Age above 18 and under 80 years of age, both gender, in good health.

- Clinical diagnosis of retinitis pigmentosa, the results of eye electrophysiological
examination accord with retinitis pigmentosa.

- The BCVA of target eye will not be better than 20/400.

- The BCVA of contralateral eye is not worse than 20/400.

- Diopter is smaller than 8.00 D, axial 28 mm or less.

- Voluntary as test subjects, signed informed consent, regular follow-up will be
effected according to the specified time.

Exclusion Criteria:

- Subject with other additional retinal diseases, like diabetic or hypertensive
retinopathy vascular diseases.

- Target eye ever have had a eye surgery;

- Subject with active serious diseases of the digestive system, liver kidney impairment
(ALT/AST) > 1.5 or any known liver disease, creatine > 1.3 mg/dL) and/serious temic
diseases, such as cardiovascular tem, respiratory tem, nervous tem, endocrine tem
urogenital tem diseases, etc.), the history of malignancy;

- Have been ready for pregnancy during test, are lactating women;

- Ready to birth of men during the test;

- Subject with any immunodeficiency;

- Subject in the immunosuppressive therapy in the current;

- Subject with the tacrolimus or other large ring lactone class drug allergies;

- Participate in any clinical subjects in nearly six months;

- Has a history of alcohol or illicit drug abuse;

- Poor adherence to complete studies;

- Researchers believe that there may be an increased risk subjects or interfere with the
clinical trials of any situation (such as when a patient is prone to mental tension,
depression, mental illness, cognitive dysfunction, etc.).

Contacts and Locations
Contacts

Contact: Wang Liu, Doctor +86-01064807858 wangliu@ioz.ac.cn

Contact: Hao Jie, Doctor +86-01062558737 haojie@ioz.ac.cn

Locations

China, Beijing
Beijing Tongren Hospitol,Capital Medical University
Beijing

Sponsors and Collaborators

Qi Zhou

Beijing Tongren Hospital

Investigators

Principal Investigator: Zhou Qi, Doctor Institute of zoology, Chinese Academy of Sciences

More Information
  • Responsible Party: Qi Zhou
  • ClinicalTrials.gov Identifier: NCT03944239 History of Changes
  • Other Study ID Numbers: ChineseASZQ-002
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: March 26, 2020
  • Last Verified: March 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Retinitis Pigmentosa Retinitis