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Treatment of RP and LCA by Primary RPE Transplantation

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ClinicalTrials.gov Identifier: NCT03566147
Recruitment Status : Unknown
Verified June 2018 by Eyecure Therapeutics Inc..
Recruitment status was:  Recruiting
First Posted : June 21, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
Beijing Tongren Hospital
Information provided by (Responsible Party):
Eyecure Therapeutics Inc.

Study Description
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Brief Summary:
Early Phase I Study of the Safety and Preliminary Efficacy of Human primary Retinal Pigment Epithelial (HuRPE) Cells Subretinal Transplantation in Retinitis Pigmentosa (RP) and Leber Congenital Amaurosis (LCA) Patients

Condition or disease Intervention/treatment Phase
Leber Congenital Amaurosis, Retinitis Pigmentosa Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis by Primary Retinal Pigment Epithelial Cells Transplantation
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: low dose group
300,000 HuRPE cells
 Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells
HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.
Experimental: middle dose group
500,000 HuRPE cells
 Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells
HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.
Experimental: high dose group
1,000,000 HuRPE cells
 Biological: Human primary Retinal Pigment Epithelial (HuRPE) cells
HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.


Outcome Measures
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Primary Outcome Measures :
  1. best-corrected visual acuity (BCVA) [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT03566147


Contacts
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Contact: Jingxue Zhang, Dr 86-18610772626 jingxuezh@163.com

Locations
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China
Beijing Tongren Hospital Recruiting
Beijing, China
Contact: Jingxue Zhang, Dr    18610772626    jingxuezh@163.com   
Sponsors and Collaborators
Eyecure Therapeutics Inc.
Beijing Tongren Hospital
Investigators
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Principal Investigator: Ningli Wang Beijing Tongren Hospital
More Information
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Responsible Party: Eyecure Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT03566147    
Other Study ID Numbers: TR-RPE-RP/LCA
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: August 9, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Blindness
Retinitis
Retinitis Pigmentosa
Leber Congenital Amaurosis
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
 Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases