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

Primary Purpose

Macular Degeneration, Stargardt's Macular Dystrophy

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Subretinal transplantation
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Human embryo stem cell derived retinal pigment epitheliums, Subretinal transplantation, Wet Age related Macular degeneration, Stargardt's macular dystrophy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Southwest Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hESC-RPE

Arm Description

Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums

Outcomes

Primary Outcome Measures

Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]
Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment

Secondary Outcome Measures

Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize
Visual acuity is reflected by number of ETDR letters participants can recognize
Visual Field as examined by Static perimetry
Area and sensitivity of visual field are detected by Static perimetry
Flash Electroretinogram (FERG)
Retinal electrophysiological function is tested by FERG
Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)
Optic nerve function as assessed by FVEP
Multifocal Electroretinogram (MFERG)
Local retinal function as assessed by MFERG

Full Information

First Posted
January 7, 2016
Last Updated
January 29, 2018
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT02749734
Brief Title
Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
Official Title
Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Stargardt's Macular Dystrophy
Keywords
Human embryo stem cell derived retinal pigment epitheliums, Subretinal transplantation, Wet Age related Macular degeneration, Stargardt's macular dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hESC-RPE
Arm Type
Experimental
Arm Description
Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums
Intervention Type
Procedure
Intervention Name(s)
Subretinal transplantation
Intervention Description
Transplant hESC-RPE into subretinal space of patients with macular degeneration
Primary Outcome Measure Information:
Title
Number of participants with Treatment-Related Adverse Events [Safety and Tolerability]
Description
Patients with Treatment-Related Adverse Events caused by local rejection of implanted cells or systemic immunosuppression treatment
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize
Description
Visual acuity is reflected by number of ETDR letters participants can recognize
Time Frame
up to 12 months
Title
Visual Field as examined by Static perimetry
Description
Area and sensitivity of visual field are detected by Static perimetry
Time Frame
up to 12 months
Title
Flash Electroretinogram (FERG)
Description
Retinal electrophysiological function is tested by FERG
Time Frame
up to 12 months
Title
Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)
Description
Optic nerve function as assessed by FVEP
Time Frame
up to 12 months
Title
Multifocal Electroretinogram (MFERG)
Description
Local retinal function as assessed by MFERG
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China

12. IPD Sharing Statement

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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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