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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 7, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date January 31, 2018
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02749734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
  • 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
  • Visual Field as examined by Static perimetry [ Time Frame: up to 12 months ]
    Area and sensitivity of visual field are detected by Static perimetry
  • Flash Electroretinogram (FERG) [ Time Frame: up to 12 months ]
    Retinal electrophysiological function is tested by FERG
  • Amplitude and Latency of Flash Visual Evoked Potentials (FVEP) [ Time Frame: up to 12 months ]
    Optic nerve function as assessed by FVEP
  • Multifocal Electroretinogram (MFERG) [ Time Frame: up to 12 months ]
    Local retinal function as assessed by MFERG
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
Official Title  ICMJE Clinical Study of Subretinal Transplantation of Human Embryo Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Macular Degeneration Diseases
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Degeneration
  • Stargardt's Macular Dystrophy
Intervention  ICMJE Procedure: Subretinal transplantation
Transplant hESC-RPE into subretinal space of patients with macular degeneration
Study Arms  ICMJE Experimental: hESC-RPE
Subretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums
Intervention: Procedure: Subretinal transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 20, 2016)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02749734
Other Study ID Numbers  ICMJE 2013CB967002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ZhengQin Yin, Southwest Hospital, China
Study Sponsor  ICMJE Southwest Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Southwest Hospital, China
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP