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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03566147 |
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Date of registration:
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12/06/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Treatment of RP and LCA by Primary RPE Transplantation
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Scientific title:
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Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation |
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Date of first enrolment:
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August 1, 2018 |
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Target sample size:
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30 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT03566147 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Ningli Wang |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing Tongren Hospital |
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Name:
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Jingxue Zhang, Dr |
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Address:
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Telephone:
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18610772626 |
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Email:
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jingxuezh@163.com |
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Affiliation:
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Name:
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Jingxue Zhang, Dr |
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Address:
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Telephone:
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86-18610772626 |
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Email:
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jingxuezh@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Diagnosis of RP or LCA;
2. Experimental eye with best-corrected visual acuity (BCVA) of no more than 35 letters
or visual field of less than 10 degree;
3. Patient understand and sign the consent form.
Exclusion Criteria:
1. Blood routine examination is abnormal (hemoglobin<10gm/dL; blood platelet
count<100k/mm³; neutrophil count<1000/mm³)
2. Blood biochemistry is abnormal (ALT/AST>1.5; creatinine>1.3mg/dL)
3. Experimental eye has optic nerve atrophy caused by glaucoma
4. Experimental eye has retinal detachment, or has received retinal detachment surgery.
5. Patients with uveitis and other endophthalmitis
6. Patients with other ocular disease affecting vision.
7. Patients have participated in clinical study of ocular or systemic drug use in recent
6 months.
8. Patients with medical history of malignant cancer (except resected basal cell
carcinoma and squamous-cell carcinoma).
9. Patients with medical history of myocardial infarction
10. Patient with diabetes
11. Patient with Parkinson disease or Alzheimer's disease
12. Patients are under the treatment of immunosuppressive agent (except intermittent,
low-dose corticosteroid treatment).
13. Patients with other medical conditions that restricts the compliance and safety of
patients, or affects experimental results.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leber Congenital Amaurosis, Retinitis Pigmentosa
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Intervention(s)
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Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells
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Primary Outcome(s)
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best-corrected visual acuity (BCVA)
[Time Frame: 12 months]
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Secondary ID(s)
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TR-RPE-RP/LCA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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