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Dry Age Related Macular DegenerationPhase 1NCT03305029

The Safety and Tolerability of Sub-retinal Transplantation of SCNT-hES-RPE Cells in Patients With Advanced Dry AMD

A Phase 1 study testing SCNT-hES-RPE Cells in people with Dry Age Related Macular Degeneration, run by CHA University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the safety and tolerability of human somatic cell nuclear transfer embryonic stem cell derived retinal pigmented epithelial(SCNT-hES-RPE) cellular therapy in patients with advanced dry AMD Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Dry Age Related Macular Degeneration
What is being tested?
SCNT-hES-RPE Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteSouth Korea
Study dates
May 2016to Apr 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male or female over 50 years of age.
  • Patient should be in sufficiently good health to reasonably expect survival for at least four years after treatment
  • Clinical findings consistent with advanced dry AMD with evidence of one or more areas of >250 microns of geographic atrophy (as defined in the Age-Related eye Disease Study [AREDS] study) involving the central fovea.
  • GA defined as attenuation or loss of RPE as observed by biomicroscopy, OCT, and FA.
  • The visual acuity (BCVA) of the eye to receive the transplant will be no better than 20/200 in Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity.
  • The visual acuity (BCVA) of the eye that is NOT to receive the transplant will be same or better than the eye to receive the transplant
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  • Medically suitable to undergo vitrectomy and subretinal injection.
  • Medically suitable for general anesthesia or waking sedation, if needed.
  • If female and of childbearing potential, willing to medically acceptable methods of contraception during the study.
  • If male, willing to use barrier and spermicidal contraception during the study.
  • Willing to defer all future blood, blood component or tissue donation.
  • Able to understand and willing to sign the informed consent.

Who cannot join

  • Presence of active or inactive CNV in the eye to be treated.
  • Presence or history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serious choroidopathy, diabetic retinopathy, other retinal vascular or degenerative disease other than ARMD, optic neuropathy, uveitis, intraocular inflammatory disease, retinal detachment repair or any other sight-threatening ocular disease.
  • Presence of glaucomatous optic neuropathy in the study eye, uncontrolled IOP, or use of two or more agents to control IOP (acetazolamide, beta blocker, alpha-1-agonist, prostaglandins, anhydrous carbonic inhibitors)
  • Cataract of sufficient severity likely to necessitate surgical extraction within 1 year.
  • Axial myopia of greater than -8 diopters.
  • Axial length greater than 28 mm.
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  • Presence of significant lens opacities or other media opacity.
  • History of ocular lens removal within previous 3 months in the study eye.
  • History of ocular surgery in the study eye in the previous 3 months in the study eye.
  • History of malignancy or evidence of malignancy in screening test.
  • Medically not suitable for transplantation of an embryonic stem cell line: Any laboratory value which falls slightly outside of the normal range will be reviewed by the Medical Monitor and Investigators to determine its clinical significance. If it is determined not to be clinically significant, the patient may be enrolled into the study.
  • History of drug abuse, identified in medical history taking.
  • Serologic evidence of infection with Hepatitis B, Hepatitis C, or HIV.
  • Any immunodeficiency.
  • Negative cancer screening within previous 12 months: complete history \& physical examination; negative chest roentgenogram (CXR); negative blood test(including CBC \& manual differential); negative urinalysis (U/A); normal thyroid exam(T3, T4, TSH); if male, negative for prostate specific antigen (PSA); negative for upper gastrointestinal series or esophagogastroduodenoscopy; negative for α-fetoprotein(AFP); negative fecal occult blood test \& negative colonoscopy; if female, normal clinical breast exam and, negative mammogram, negative breast ultrasonography; if female, normal pelvic examination with Papanicolaou smear;
  • Any of the below criteria of diabetes : Fasting blood glucose≥126mg/dl; random plasma glucose with typical symptoms of diabetes≥200mg/dl; HbA1c ≥ 7%
  • History of myocardial infarction or cerebrovascular accident in previous 12 months.
  • History of cognitive impairments or dementia which may impact the patients ability participate in the informed consent process and to appropriately complete evaluations.
  • Current participation in any other clinical trial.
  • Participation within previous 6 months in any clinical trial of a drug by ocular or systemic administration.
  • If female, pregnancy or lactation.
  • Any other medical condition, which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromises patient safety, or interferes with the interpretation of the study results.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • CHA Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 463-712

Other trials in South Korea

About this study

Official title: Open-Label, Single-Center, Prospective Study to Determine the Safety and Tolerability of Sub-retinal Transplantation of SCNT-hES-RPE Cells in Patients With Advanced Dry AMD

To evaluate the safety and tolerability of human somatic cell nuclear transfer embryonic stem cell derived retinal pigmented epithelial(SCNT-hES-RPE) cellular therapy in patients with advanced dry AMD

Read the detailed description

To evaluate the safety and tolerability of the SCNT-hES-RPEs, to assess the number of SCNT-hES-RPE cells to be transplanted in future studies and to evaluate on an exploratory basis potential efficacy endpoints to be used in future studies of SCNT-hES-RPE cellular therapy.

Being tested
SCNT-hES-RPE Cells
Keywords
Age related macular degeneration, embryonic stem cells, somatic cell nuclear transfer
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCNT-hES-RPE CellsDrug

    Pars Plana Vitrectomy and Sub-retinal Transplantation of Human Somatic cell nuclear transfer Embryonic Stem Cell Derived Retinal Pigmented Epithelial(SCNT-hES-RPE) Cells in Patients with Advanced Dry Age-related Macular Degeneration

Study groups in NCT03305029
Study groupRoleWhat they receive
SCNT-hES-RPE CellsExperimentalPars plana vitrectomy and Sub-retinal Transplantation of Human Somatic cell nuclear transfer Embryonic Stem Cell Derived Retinal Pigmented Epithelial Cells (SCNT-hES-RPE Cells) in Patients with Advanced Dry Age-related Macular Degeneration(AMD)
Receives: Drug: SCNT-hES-RPE Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of SCNT-hES-RPE cells

    The transplantation of SCNT-hES-RPE cells will be considered safe in the absence of:

    1. Any grade 2 (NCI CTCAE V4.03) or greater adverse event related to the cell product
    2. Any evidence that the cells are contaminated with an infectious agent
    3. Any evidence that the cells show tumorigenic potential

    Measured: 60 months

Secondary outcomes (4)

  1. ● Change in the mean of BCVA

    Best corrected ETDRS visual acuity scores

    Measured: 60 months

  2. ● Autofluorescence photography

    Autofluorescence photography of GA

    Measured: 60 months

  3. ● Reading speed

    MNReading speed measurements

    Measured: 60 months

  4. ● Structural evidence (OCT imaging, fluorescein angiography, autofluorescense photography, slitlamp examination with fundus phot ography) that cells have been implanted in the correct location

    Evidence of structural changes

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2017
  2. Study startMay 2016
  3. Primary completionApr 2019 (estimated)
  4. Study completionApr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03305029
Sponsor's protocol ID
CHA2015-08-141
Status last verified
Oct 2017
First submitted
6 Jul 2016
Last updated
9 Oct 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SCNT-hES-RPE Cells in people with Dry Age Related Macular Degeneration, run by CHA University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of SCNT-hES-RPE cells (time frame: 60 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03305029.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.

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