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Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases

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ClinicalTrials.gov Identifier: NCT02749734
Recruitment Status : Active, not recruiting
First Posted : April 25, 2016
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
ZhengQin Yin, Southwest Hospital, China

Brief Summary:
The purpose of this study was to determine the safety and therapeutic effect of sub-retinal transplantation of human embryo stem cell derived retinal pigment epitheliums (hESC-RPE) in patients with macular degeneration diseases, and explore new treatment modalities for macular degeneration diseases (Age-related macular degeneration and Stargardt's macular dystrophy).

Condition or disease Intervention/treatment Phase
Macular Degeneration Stargardt's Macular Dystrophy Procedure: Subretinal transplantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: hESC-RPE
Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums
Procedure: Subretinal transplantation
Transplant hESC-RPE into subretinal space of patients with macular degeneration




Primary Outcome Measures :
  1. Number of participants with Treatment-Related Adverse Events [Safety and Tolerability] [ Time Frame: up to 12 months ]
    Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment


Secondary Outcome Measures :
  1. Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize [ Time Frame: up to 12 months ]
    Visual acuity is reflected by number of ETDR letters participants can recognize

  2. Visual Field as examined by Static perimetry [ Time Frame: up to 12 months ]
    Area and sensitivity of visual field are detected by Static perimetry

  3. Flash Electroretinogram (FERG) [ Time Frame: up to 12 months ]
    Retinal electrophysiological function is tested by FERG

  4. Amplitude and Latency of Flash Visual Evoked Potentials (FVEP) [ Time Frame: up to 12 months ]
    Optic nerve function as assessed by FVEP

  5. Multifocal Electroretinogram (MFERG) [ Time Frame: up to 12 months ]
    Local retinal function as assessed by MFERG



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aging from 18 to 75 years
  • must have signed informed consent
  • At least one visually impaired eye caused by macular degeneration diseases
  • Can not be effectively treated with conventional therapies
  • Best corrected visual acuity scores between 19 and 73 letter in ETDRs (early treatment diabetic retinopathy ) eye chart , including 19 and 73 (or the equivalent of Snellen eyesight from 20/400 to 20/40)
  • Visual loss caused by macular degeneration diseases

Exclusion Criteria:

  • Eyes with concomitant diseases which will interfere the visual improvement of the study
  • Active intraocular inflammation regardless of the grade of severity
  • Active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, ophthalmia)
  • History of uveitis
  • Severe cataract, glaucoma, retinal blood vessels occlusion, retinal detachment, macular hole, vitreous-macula traction
  • Iris neovascularization
  • Patients who have only one functioning eye, or the best corrected vision of untreated eye scores less than 24 letters in ETDRS chart(corresponding to 20/320 in Snellen chart)
  • History of intraocular surgery
  • Severe systemic diseases: Stroke, coronary heart disease, angina pectoris, renal insufficiency needing dialysis
  • Allergic to sodium fluorescein
  • Uncontrolled hypertension (systolic pressure>140mmHg,or diastolic pressure>90mmHg)
  • Coagulative function disorder
  • System administration of drugs that are toxic to lens, retina, or optic nerve like hydroxychloroquine, phenothiazine, ethambutol, tamoxifen, etc.
  • Involved in other clinical trials of any medicine within 1 month (or within 5 half-life periods)
  • Have maternity plan in 6 months
  • In pregnancy or lactation period.

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): NCT02749734


Locations
China, Chongqing
Southwest Hospital
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Southwest Hospital, China

Responsible Party: ZhengQin Yin, Professor, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02749734     History of Changes
Other Study ID Numbers: 2013CB967002
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by ZhengQin Yin, Southwest Hospital, China:
Human embryo stem cell derived retinal pigment epitheliums
Subretinal transplantation
Wet Age related Macular degeneration
Stargardt's macular dystrophy

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