Limbus CorneaePhase 1NCT04773431
Safety Evaluation of LSCD101 Transplantation for Limbal Stem Cell Deficiency
A Phase 1 study testing LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation in people with Limbus Corneae and Limbus Corneae Insufficiency Syndrome, run by CliPS Co., Ltd at 1 site in South Korea.
Trial summary
Clinical Study Objective: To evaluate the tolerability and safety after transplantation of LSCD101 in patients with intractable limbal stem cell deficiency Study Method: Subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Limbus Corneae, Limbus Corneae Insufficiency Syndrome
- What is being tested?
- LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Jan 2020to 14 Jan 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 19 or older
- Diagnosed with intractable limbal stem cell deficiency in single eye, with severity in which corneal neovascularization invades more than two quadrants
- No improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment
- BCVA 20/40 or less at screening in the eye with the limbal stem cell deficiency
- Voluntarily agreed to participate in this study and signed a consent form
Who cannot join
- Inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet.
- Difficulty in reconstruction of the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency.
- Severe dry eye with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia < 2 mm/5 min at screening)
- Acute ocular surface inflammation of both corneas at Visit 2
- Malignant tumor history (except in case of no recurrence more than 5 years after surgery)
- Uncontrolled comorbidities such as moderate to severe infections and bleeding
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- Positive for virus infection (HBV, HCV, HIV, CMV, HTLVⅠ/Ⅱ, syphilis)
- Uncontrolled diabetes (HbA1c ≥9.0%)
- Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg despite taking antihypertensives at screening)
- Uncontrolled glaucoma (IOP > 21 mmHg despite taking glaucoma medication)
- Pregnant or lactating women
- Women with childbearing potential, those who do not agree to contraception by medically accepted contraceptive methods during clinical trials
- Participation in another clinical study within 4 weeks
- Subjects judged by the investigator to be inappropriate to participate in the clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study to Evaluate Safety of LSCD101(Cultured Autologous Limbal Epithelial Cell Sheet) Transplantation for Limbal Stem Cell Deficiency
Clinical Study Objective:
To evaluate the tolerability and safety after transplantation of LSCD101 in patients with intractable limbal stem cell deficiency
Study Method:
Subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the investigational product. Adverse drug reaction will be confirmed during 24 weeks after transplantation.
- Being tested
- LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantationDrug
LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
| Study group | Role | What they receive |
|---|---|---|
| LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation | Experimental | LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion. Receives: Drug: LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adverse event
Adverse event
Measured: From limbal tissue collection until 24 weeks after transplantation
Secondary outcomes (7)
Rate of normal/abnormal results in clinical laboratory test
Comparisons between pre-/post- transplantation are summarized and presented
Measured: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Blood pressure(systolic/diastolic) at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Measured: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Pulse rate at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Measured: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of normal/abnormal results in Electrocardiogram
Comparisons between pre-/post- transplantation are summarized and presented.
Measured: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of normal/abnormal results in physical examination at each visit
Comparisons between pre-/post- transplantation are summarized and presented.
Measured: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of eye infection and inflammation
Eye infection and inflammation test (slit lamp microscopy)
Measured: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Intraocular pressure test
Intraocular pressure test
Measured: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start31 Jan 2020
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbus CorneaeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CliPS Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SoHyang Chung, MD,Ph.D, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773431
- Sponsor's protocol ID
- LSCD101_P1
- Status last verified
- Jan 2021
- First submitted
- 22 Jan 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Evaluate Safety of LSCD101(Cultured Autologous Limbal Epithelial Cell Sheet) Transplantation for Limbal Stem Cell Deficiency
- ClinicalTrials.gov ID
- NCT04773431
- Acronym / sponsor ID
- LSCD101_P1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CliPS Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical Study Objective:
To evaluate the tolerability and safety after transplantation of LSCD101 in patients with intractable limbal stem cell deficiency
Study Method:
Subjects who finally meet the inclusion/exclusion criteria results of the subject eligibility evaluation will receive transplantation of the investigational product. Adverse drug reaction will be confirmed during 24 weeks after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation | Experimental | Drug: LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantationLSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 19 or older
- Diagnosed with intractable limbal stem cell deficiency in single eye, with severity in which corneal neovascularization invades more than two quadrants
- No improvement of indication by known treatment (non-surgical/surgical) method according to investigator's judgment
- BCVA 20/40 or less at screening in the eye with the limbal stem cell deficiency
- Voluntarily agreed to participate in this study and signed a consent form
Key exclusion criteria (14 listed)
- Inappropriate for harvesting limbal epithelial cells for the production of limbal epithelial cell sheet.
- Difficulty in reconstruction of the corneal epithelium because the eye is not closed due to eyelid function problems in the eye with the limbal stem cell deficiency.
- Severe dry eye with problem with tear secretion in both eyes (value of Schirmer I test without anesthesia < 2 mm/5 min at screening)
- Acute ocular surface inflammation of both corneas at Visit 2
- Malignant tumor history (except in case of no recurrence more than 5 years after surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantationLSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion. | Drug | LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation |
Primary outcome
Rate of Adverse event
Time frame: From limbal tissue collection until 24 weeks after transplantation
Adverse event
7 secondary outcomes
Rate of normal/abnormal results in clinical laboratory test
Time frame: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Blood pressure(systolic/diastolic) at each visit
Time frame: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Pulse rate at each visit
Time frame: Before treatment, 1 day, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of normal/abnormal results in Electrocardiogram
Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of normal/abnormal results in physical examination at each visit
Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Rate of eye infection and inflammation
Time frame: Before treatment, 1 week, 2 weeks, 4 weeks, 12 weeks, 24 weeks after transplantation
Intraocular pressure test
Time frame: Before treatment, 4 weeks, 12 weeks, 24 weeks after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
Related trials for Limbus Corneae
RecruitingObservational study
Limbal Stem Cell Deficiency of Genetic Origin: Genotype-phenotype Correlation
Limbus Corneae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SoHyang Chung, MD,Ph.D principal investigator
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation in people with Limbus Corneae and Limbus Corneae Insufficiency Syndrome, run by CliPS Co., Ltd 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 5 inclusion and 14 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: finished, as of the sponsor's last update on 26 Feb 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of Adverse event (time frame: From limbal tissue collection until 24 weeks after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2021.