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Trial record 1 of 1 for:    Cell Cure [Lead]
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Safety and Efficacy Study of OpRegen for Treatment of Advanced Dry-Form Age-Related Macular Degeneration

This study is currently recruiting participants.
Verified August 2017 by Cell Cure Neurosciences Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02286089
First Posted: November 7, 2014
Last Update Posted: August 29, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Cell Cure Neurosciences Ltd.
  Purpose
The main objective of the study is evaluation of the safety and tolerability of OpRegen - human embryonic stem cell-derived retinal pigment epithelial (RPE)cells. The study will also include initial exploration of the ability of transplanted OpRegen cells to engraft, survive, and moderate disease progression.

Condition Intervention Phase
Age-related Macular Degeneration Biological: OpRegen Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/IIa Dose Escalation Safety and Efficacy Study of Human Embryonic Stem Cell-Derived Retinal Pigment Epithelium Cells Transplanted Subretinally in Patients With Advanced Dry-Form Age-Related Macular Degeneration (Geographic Atrophy)

Resource links provided by NLM:


Further study details as provided by Cell Cure Neurosciences Ltd.:

Primary Outcome Measures:
  • Incidence and frequency of treatment emergent adverse events [ Time Frame: 12 months post transplantation ]
  • Treatment emergent changes of clinical and opthalmological parameters [ Time Frame: 12 months post transplantation ]

    The following measurements will be performed:

    • Vital signs
    • Hematology/ Blood Chemistry/Urinalysis
    • Physical examination
    • Ophthalmological evaluations, such as (not limited to):
    • Dilated Fundus Exam and Retinal Fundus Imaging
    • Intraocular Pressure
    • Slit Lamp Examination
    • Spectral Domain Optical Coherence Tomography
    • Fluorescein Angiography
    • Color Fundus Photography (CFP)


Secondary Outcome Measures:
  • Change in GA lesion area (sqr. mm) [ Time Frame: 12 months post transplantation ]
    Measurement of change in GA lesion area will be performed based on available imaging data by a central reading center.

  • Change in visual acuity [ Time Frame: 12 months post transplantation ]
    Change in visual acuity will be measured by ETDRS chart

  • Change in Quality of Life [ Time Frame: 12 months post transplantation ]
    Change in NEI VFQ-25 Quality of Life score will be measured from baseline


Estimated Enrollment: 15
Study Start Date: April 2015
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OpRegen
9 legally blind patients with best corrected visual acuity of 20/200 or less in first three cohorts and 6 patients with best corrected visual acuity of 20/100 or less in fourth cohort
Biological: OpRegen
Targeted dose of 50,000 - 500,000 cells will be delivered into the subretinal space following vitrectomy procedure

Detailed Description:

OpRegen® is a cell-based product composed of retinal pigment epithelial (RPE) cells, derived from human embryonic stem cells (hESC) and administered as a cell suspension in ophthalmic Balanced Salt Solution Plus (BSS Plus).

This is a Phase I/IIa, dose-escalation, single-center study, evaluating safety and tolerability of OpRegen transplantation to patients with progressive dry-AMD. The study includes also initial exploration of efficacy.

A total of 15 patients will be enrolled. The patients should be 50 years of age and older, with non-neovascular (dry) AMD, who have funduscopic findings of GA in the macula, with absence of additional concomitant ocular disorders.

The patients will be divided into four cohorts, according to their best corrected visual acuity (BCVA) and administrated OpRegen dose.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 50 and older;
  2. Diagnosis of dry (non-neovascular) age related macular degeneration in both eyes;
  3. Funduscopic findings of dry AMD with progressive geographic atrophy in the macula, above 0.5 disc area (1.25mm^2 and up to 17 mm^2) in size in the study eye and above 0.5 disc area in the fellow eye;
  4. Best corrected central visual acuity equal or less than 20/200 in cohorts 1-3 and equal or less than 20/100 in cohort 4 in the study eye by ETDRS vision testing;
  5. Vision in the non-operated eye must be better than or equal to that in the operated eye;
  6. Subjects with sufficiently good health to allow participation in all study-related procedures and complete the study follow up period (medical records);
  7. Ability to undergo a vitreoretinal surgical procedure under monitored anesthesia care;
  8. Blood counts, blood chemistry, coagulation and urinalysis without abnormal significance;
  9. Negative for HIV, HBC, and HCV, negative for CMV IgM and EBV IgM;
  10. Patients with no current or history of malignancy (with the exception of successfully treated basal/squamous cell carcinoma of the skin) based on age matched screening exam (at discretion of the study physician);
  11. Willing to defer all future blood and tissue donation;
  12. Able to understand and willing to sign informed consent.

Exclusion Criteria:

  1. Evidence of neovascular AMD by history, as well as by clinical exam, fluorescein angiography (FA), or ocular coherence tomography (OCT) at baseline in either eye;
  2. History or presence of diabetic retinopathy, vascular occlusions, uveitis, Coat's disease, glaucoma, cataract or media opacity preventing posterior pole visualization or any significant ocular disease other than AMD that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome;
  3. History of retinal detachment repair in the study eye;
  4. Axial myopia greater than -6 diopters;
  5. Cataract Surgery in the study eye in the past 6 weeks and any other ocular surgery in the study eye in the past 3 months
  6. History of cognitive impairments or dementia;
  7. Contraindication for systemic immunosuppression;
  8. History of any condition other than AMD associated with choroidal neovascularization in the study eye (e.g. pathologic myopia or presumed ocular histoplasmosis);
  9. Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
  10. Female; pregnancy or lactation;
  11. Current participation in another clinical study. Past participation (within 6 months) in any clinical study of a drug administered systemically or to the eye.
  12. Currently receiving aspirin, aspirin containing products and/or any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery.
  13. History of cancer (other than a non-melanoma skin cancer). For cancers cured more than five years ago, enrollment is allowed with concurred documented approval of principal investigator and oncologist prior to enrollment.
  Contacts and Locations
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): NCT02286089


Contacts
Contact: Devora Marks Ohana 972-2-6776324 dryamdstudy@gmail.com
Contact: Vivi Dagan 972-3-9377199 eyeclinic@clalit.org.il

Locations
United States, California
Retina Vitreous Associates Medical Group Recruiting
Los Angeles, California, United States, 90017
Contact: Janet Kurokouchi, B.Sc.    310-289-2478 ext 1243    JKurokouchi@laretina.com   
Contact: Kelly Hu, B.Sc.    (310) 289 2478 ext 1243    khu@laretina.com   
Principal Investigator: David Boyer, MD         
Sub-Investigator: Pouya N. Dayani, MD         
Sub-Investigator: David S. Liao, MD         
Sub-Investigator: Richard Roe, MD         
Sub-Investigator: Roger L. Novack, MD         
Sub-Investigator: Thomas G. Chu, MD         
Sub-Investigator: Firas M. Rahhal, MD         
Sub-Investigator: Homayoun Tabandeh, MD         
Sub-Investigator: Daniel D. Esmaili, MD         
Sub-Investigator: Jeffrey J. Tan, MD         
West Coast Retina Medical Group, Inc Recruiting
San Francisco, California, United States, 94109
Contact: Kaitlin E. Miani, BA    415-972-4607    kmiani@westcoastretina.com   
Contact: Angela C. Fender, BA    (415)9724608    a.gomez@westcoastretina.com   
Principal Investigator: Richard McDonald, MD         
Sub-Investigator: Anita Agarwal, MD         
Sub-Investigator: Ananda Kalevar, MD         
Sub-Investigator: J Michael Jumper, MD         
Sub-Investigator: Judy Ju-Yi Chen, MD         
Sub-Investigator: Arthur D. Fu, MD         
Sub-Investigator: Robert N. Johnson, MD         
Israel
Hadassah Ein Kerem University Hospital Recruiting
Jerusalem, Israel, 91120
Contact: Devora Marks Ohana    972-2-6776324    dryamdstudy@gmail.com   
Principal Investigator: Tareq Jaouni, MD         
Sub-Investigator: Yuval Tal, MD         
Sub-Investigator: Eyal Banin, MD, Prof         
Sub-Investigator: Ytzhak Hemo, MD         
Rabin Medical Center Recruiting
Petah Tikva, Israel
Contact: Vivi Dagan    972-3-9377199    eyeclinic@clalit.org.il   
Principal Investigator: Dov Weinberger, MD, Prof.         
Sub-Investigator: Ruth Siegel, MD, Prof.         
Sub-Investigator: Irit Rosenblat, MD         
Sub-Investigator: Rita Ehrlich, MD         
Sub-Investigator: Iris Daitch, MD         
Sub-Investigator: Herrado Morvenik, MD         
Sub-Investigator: Irena Srov, MD         
Sub-Investigator: Michal Shahaf-Fogler, MD         
Sub-Investigator: Orly Gal Or, MD         
Sub-Investigator: Kfir Tal, MD         
Kaplan Medical Center Recruiting
Rehovot, Israel
Contact: Michal Scwartzberg    972-8-9441691    kaplaneye1@gmail.com   
Principal Investigator: Ayala Pollack, MD, Prof.         
Sub-Investigator: Haia Morori-Katz, MD         
Sub-Investigator: Amir Bukelman, MD         
Sub-Investigator: Reut Parness-Yosifon, MD         
Sub-Investigator: Oren Yovel-Shmuel, MD         
Sub-Investigator: Yoel Greenwald, MD         
Sub-Investigator: Alexandra Goz, MD         
Sub-Investigator: Guy Kleinman, MD         
Sub-Investigator: Arie Marcovich, MD         
Sub-Investigator: Tamir Vainberg, MD         
Tel Aviv Souraski Medical Center Recruiting
Tel Aviv, Israel, 91121
Contact: Sagit Bechor    03-6974361    sagitba@tlvmc.gov.il   
Principal Investigator: Adiel Barak, MD, Prof.         
Sub-Investigator: Anat Loewenstein, MD, Prof.         
Sub-Investigator: Michaela Goldshtein, MD         
Sub-Investigator: Shiri Shulman, MD         
Sub-Investigator: Michael Regenbogen, MD         
Sub-Investigator: Sholamit Shortz, MD         
Sub-Investigator: Hadas Nueman, MD         
Sub-Investigator: Zohar Habot-Wilner, MD         
Sub-Investigator: Nurit Erlich, MD         
Sub-Investigator: Dina Zur, MD         
Sub-Investigator: Efrat Flysing, MD         
Sub-Investigator: Nor Azam, MD         
Sub-Investigator: Michael Martinez, MD         
Sponsors and Collaborators
Cell Cure Neurosciences Ltd.
Investigators
Study Director: Maria Gurevich Cell Cure Neurosciences Ltd.
Principal Investigator: Tareq Jaouni, MD Hadassah Ein Kerem University Hospital
Principal Investigator: Dov Weinberger, MD, Prof. Rabin Medical Center
Principal Investigator: Ayala Pollack, MD, Prof. Kaplan Medical Center
Principal Investigator: Adiel Barak, MD, Prof. Tel Aviv Souraski Medical Center
Principal Investigator: Richard McDonald, MD West Coast Retina Medical Group, Inc.
Principal Investigator: David Boyer, MD Retina-Vitreous Associates Medical Group
  More Information

Publications:
Responsible Party: Cell Cure Neurosciences Ltd.
ClinicalTrials.gov Identifier: NCT02286089     History of Changes
Other Study ID Numbers: CCN_CT02
First Submitted: November 2, 2014
First Posted: November 7, 2014
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Cell Cure Neurosciences Ltd.:
dry-AMD
Geographic Atrophy

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