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Macular DegenerationPhase 1/2NCT02749734

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

A Phase 1/2 study testing Subretinal transplantation in people with Macular Degeneration and Stargardt's Macular Dystrophy, run by Southwest Hospital, China at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Subretinal transplantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
May 2015to Dec 2019
Phase
Phase 1/2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Southwest Hospital

    Chongqing, Chongqing Municipality, 400038

Other trials in China

About this study

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).

Being tested
Subretinal transplantation
Keywords
Human embryo stem cell derived retinal pigment epitheliums, Subretinal transplantation, Wet Age related Macular degeneration, Stargardt's macular dystrophy
Medical subject headings
Macular Degeneration

What participants receive

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

  • Subretinal transplantationProcedure or surgery

    Transplant hESC-RPE into subretinal space of patients with macular degeneration

Study groups in NCT02749734
Study groupRoleWhat they receive
hESC-RPEExperimentalSubretinal transplantation of Human embryo stem cell derived retinal pigment epitheliums
Receives: Procedure: Subretinal transplantation

What is being measured

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

  1. 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

    Measured: up to 12 months

Secondary outcomes (5)

  1. Number of Early Treatment Diabetic Retinopathy (ETDR ) letters participants can recognize

    Visual acuity is reflected by number of ETDR letters participants can recognize

    Measured: up to 12 months

  2. Visual Field as examined by Static perimetry

    Area and sensitivity of visual field are detected by Static perimetry

    Measured: up to 12 months

  3. Flash Electroretinogram (FERG)

    Retinal electrophysiological function is tested by FERG

    Measured: up to 12 months

  4. Amplitude and Latency of Flash Visual Evoked Potentials (FVEP)

    Optic nerve function as assessed by FVEP

    Measured: up to 12 months

  5. Multifocal Electroretinogram (MFERG)

    Local retinal function as assessed by MFERG

    Measured: up to 12 months

Timeline

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

  1. First posted25 Apr 2016 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2018 (estimated)
  4. Study completionDec 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749734
Sponsor's protocol ID
2013CB967002
Status last verified
Jan 2018
First submitted
7 Jan 2016
Last updated
31 Jan 2018
Results posted
No
Data monitoring committee
No

Publications

  • Lv YX, Li QY, Duan P, Zhang MF, Liu B, Li SY, Zhao TT, Wang H, Liu Y, Yin ZQ. Safe CNV removal is crucial for successful hESC-RPE transplantation in wet age-related macular degeneration. Stem Cell Reports. 2025 Mar 11;20(3):102424. doi: 10.1016/j.stemcr.2025.102424. Epub 2025 Feb 27.

    PubMed 40020685

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Subretinal transplantation in people with Macular Degeneration and Stargardt's Macular Dystrophy, run by Southwest Hospital, China at 1 site in China.

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 6 inclusion and 16 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 31 Jan 2018. 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 China. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Number of participants with Treatment-Related Adverse Events [Safety and Tolerability] (time frame: up to 12 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 NCT02749734, which also lists 1 linked publication.

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 31 Jan 2018.

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