- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03944239
Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
March 25, 2020 updated by: Qi Zhou
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
10
Phase
- 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
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Beijing Tongren Hospitol,Capital Medical University
-
Contact:
- Wei Wen bin, Doctor
- Phone Number: +86-01058265736
- Email: weiwenbintr@163.com
-
Contact:
- Shen chang, Doctor
- Phone Number: +86-010-58269804
- Email: shenc_0526@163.com
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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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.).
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 epitheliums transplantation
Transplant clinical-grade hESC derived retinal pigment epitheliums into subretinal of patients with retinitis pigmentosa.The dosage is 150000.
|
Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of visual function
Time Frame: one year
|
The changes of BCVA and EDTRS were observed one year after surgery.
|
one year
|
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 (Anticipated)
May 1, 2020
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
December 27, 2018
First Submitted That Met QC Criteria
May 8, 2019
First Posted (Actual)
May 9, 2019
Study Record Updates
Last Update Posted (Actual)
March 26, 2020
Last Update Submitted That Met QC Criteria
March 25, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChineseASZQ-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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