Limbal Stem Cells DeficiencyPhase 1/2NCT06700655
A Clinical Study on Co-transplantation of Autologous Limbal Stem Cells and Corneal Stromal Stem Cells to Repair Corneal Injury
A Phase 1/2 study testing Cornea limbal stem cell transplantation group, Corneal transplantation and Cornea limbal stem cell transplantation combined corneal stromal stem cell group in people with Limbal Stem Cells Deficiency, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
This study aims to: 1) verify the feasibility of treating limbal stem cell deficiency (LSCD) caused by chemical injury with autologous limbal stem cell transplantation combined with corneal stromal stem cell transplantation; 2) evaluate the corneal healing patterns following autologous stem cell transplantation; and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Limbal Stem Cells Deficiency
- What is being tested?
- Cornea limbal stem cell transplantation group, Corneal transplantation and Cornea limbal stem cell transplantation combined corneal stromal stem cell group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Mar 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chemical injury from acid or alkali exposure
- Extensive limbal stem cell deficiency (greater than 180 degrees), with corneal stromal opacity not exceeding a depth of 250 μm
- Corneal epithelial conjunctivalization and fibrosis, with neovascularization extending into more than half of the quadrants
- Unilateral ocular involvement, with normal limbal stem cell function in the contralateral healthy eye
- No significant improvement in ocular surface signs and symptoms after pharmacological or surgical interventions, stable for over three months
Who cannot join
- Bilateral corneal stem cell deficiency, such as in Stevens-Johnson syndrome, ocular cicatricial pemphigoid, or congenital aniridia
- Subclinical limbal stem cell deficiency in the contralateral eye
- Signs of corneal endothelial decompensation, such as corneal bullae or corneal edema
- Presence of infectious inflammation on the ocular surface
- Severe dry eye
- Eyelid abnormalities requiring corrective surgery to restore normal anatomical structure
Show all 19Show fewer
- Presence of chronic dacryocystitis, cataracts, uveitis, diabetic retinopathy, retinal detachment, or other ocular diseases
- Patients who have undergone cataract surgery or other intraocular procedures
- Glaucoma patients requiring long-term topical ocular medications
- History of corneal perforation in the affected eye
- Severe primary cardiovascular, hepatic, renal, endocrine, or hematologic disorders, diabetes, or immune deficiency in the medical history
- Pregnant or lactating women
- Positive screening for infectious diseases (HIV, HBV, HTLV, EBV, CMV, or syphilis)
- Other vision-impairing diseases present
- Allergy to bovine serum products
- History of multiple drug allergies or hypersensitive constitution
- Concurrent participation in other drug clinical trials
- History of mental health disorders affecting the ability to comply with study requirements
- Judged unsuitable for participation by the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study on Co-transplantation of Autologous Limbal Stem Cells and Corneal Stromal Stem Cells to Repair Corneal Injury: an Open-label, Randomized Clinical Trial
This study aims to: 1) verify the feasibility of treating limbal stem cell deficiency (LSCD) caused by chemical injury with autologous limbal stem cell transplantation combined with corneal stromal stem cell transplantation; 2) evaluate the corneal healing patterns following autologous stem cell transplantation; and 3) establish a clinical intervention protocol based on autologous corneal stem cell transplantation. Sixty cases of single-eye LSCD were included.
Read the detailed description
Limbal Stem Cells (LSCs) are the sole source of corneal epithelial self-renewal and play a critical role in maintaining corneal transparency. Chemical or physical injury to the eye and inflammation can lead to limbal stem cell deficiency (LSCD), accompanied by a series of pathological changes, such as irreversible fibrosis of corneal stromal cells and neovascularization, ultimately resulting in blindness. The fundamental solution for such diseases is the replenishment of LSCs to reconstruct a functional cornea. However, traditional treatment methods, such as corneal transplantation, face bottlenecks, including a severe shortage of corneal donors and the risk of immune rejection. Additionally, donor corneas do not contain LSCs, making it impossible to reconstruct the patient's limbal region, resulting in poor long-term efficacy.
In 2015, autologous LSCs were approved by the European Union as a commercial stem cell product for treating patients with chemically induced LSCD. However, LSCD patients are often accompanied by damage to the corneal stroma; while LSC transplantation can restore the limbal region and corneal epithelium, it cannot repair stromal opacities. Research indicates that transplantation of corneal stromal stem cells can reconstruct organized collagen structures and restore stromal transparency. Over the past decade, clinical studies using LSCs and corneal stromal stem cells to treat LSCD patients have been conducted in multiple countries, demonstrating the safety and efficacy of these stem cell therapies for corneal blindness.
Based on these findings above, the investigators have established a serum-free, carrier-free culture system that enables efficient and uniform in vitro expansion of functional LSCs and corneal stromal stem cells. By obtaining a 2 x 5 mm limbal tissue sample from the healthy eye of the patient, the investigators can acquire a sufficient number of cells for transplantation. Preclinical studies have confirmed that the expanded cells are effective and safe for treating LSCD animal models. This study aims to use autologous LSCs combined with corneal stromal stem cell transplantation to treat patients with unilateral LSCD, restoring their corneal transparency and visual function. This approach provides a novel treatment method for patients and promotes the application of stem cell regenerative medicine for the treatment of corneal blindness in China.
- Conditions
- Limbal Stem Cells Deficiency
- Being tested
- Cornea limbal stem cell transplantation group, Corneal transplantation, Cornea limbal stem cell transplantation combined corneal stromal stem cell group
- Keywords
- Limbal stem cell, Limbal stem cells deficiency, Corneal stromal stem cells, Corneal transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cornea limbal stem cell transplantation groupBiological
The corneal limbal tissue (2mm x 5mm) was harvested from the patient's healthy eye, and ex vivo amplification was performed to obtain an adequate quantity of transplantable corneal limbal stem cells.
Corneal transplantationProcedure or surgery
The patient awaited allogeneic corneal donation and underwent corneal transplantation surgery.
Cornea limbal stem cell transplantation combined corneal stromal stem cell groupBiological
The corneal limbal tissue (2mm x 5mm) was harvested from the patient's healthy eye, and ex vivo amplification was performed to obtain an adequate quantity of transplantable corneal limbal stem cells and corneal stromal stem cells.
| Study group | Role | What they receive |
|---|---|---|
| Cornea limbal stem cell transplantation group | Experimental | The corneal limbal tissue (2mm x 5mm) was harvested from the patient's healthy eye, and ex vivo amplification was performed to obtain an adequate quantity of transplantable corneal limbal stem cells The patient was followed up and re-examined for 2 years postoperatively. Receives: Biological: Cornea limbal stem cell transplantation group |
| Cornea limbal stem cell transplantation combined corneal stromal stem cell group | Experimental | The corneal limbal tissue (2mm x 5mm) was harvested from the patient's healthy eye, and ex vivo amplification was performed to obtain an adequate quantity of transplantable corneal limbal stem cells and corneal stromal stem cells. The patient was followed up and re-examined for 2 years postoperatively. Receives: Biological: Cornea limbal stem cell transplantation combined corneal stromal stem cell group |
| Corneal transplantation group | Active comparator | The patient awaited allogeneic corneal donation and underwent corneal transplantation surgery. Postoperatively, the patient was followed up and re-examined for 2 years. Receives: Procedure: Corneal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision
The patient should initially be positioned 5 meters from the visual acuity chart in a well-lit environment. Each eye is tested separately (the non-tested eye should be completely covered with an eye patch without applying pressure on the eyeball). During the test, the patient first views the largest line on the chart. If they can identify it, they proceed from top to bottom, viewing progressively smaller lines until the smallest identifiable line is determined. The patient should not spend more than 5 seconds reading each character.
Measured: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
Secondary outcomes (8)
Efficacy Scoring
The efficacy of cell transplantation will be evaluated based on corneal epithelial defect, area of leukoplakia, transparency, neovascularization, and corneal edema.
Measured: [set the corneal limbal tissue sampling date at the begin] First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
Ocular adverse event evaluation
The transplantation area for the cells is the ocular surface, so the primary measure of safety will focus on post-transplant ocular symptoms. These include eye irritation symptoms, conjunctival hyperemia, corneal surface edema, and anterior chamber flare. Adverse events are defined as follows: eye irritation symptoms scoring ≥1, conjunctival hyperemia scoring ≥2, corneal surface edema scoring ≥2, anterior chamber flare scoring ≥2, or a total score of 7 or above.
The healthy eye requires postoperative observation, and if infection or delayed healing occurs after tissue sampling, treatment will be necessary.
Measured: [set the corneal limbal tissue sampling date at the begin] before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
ophthalmic examination（slit-lamp）
including cornea, conjunctiva, lens, vitreous body and retina. Score each indicator from 0 to 3 based on the standards in the table, and then calculate the final score.
Measured: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
cornea confocal
Corneal microscopic structure examination. Observe whether the morphology of each layer of the cornea is normal.
Measured: [set the tissue sampling date at the begin] Enrollment, before the transplantation, Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
corneal topography
Analyze the morphology and curvature characteristics of the entire corneal surface.
Measured: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
Optical Coherence Tomography
Observe the depth of corneal lesions to assess the condition and treatment efficacy.
Measured: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
anterior segment photography
record the statement of ocular surface
Measured: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
VFQ-25 questionnaire
The VFQ-25 (Visual Function Questionnaire-25) is a widely used tool to assess the health-related quality of life related to visual function. It consists of 25 questions to evaluate how vision affects daily activities, emotional well-being, and social interactions. The questionnaire covers several domains: general vision, near and distance vision, social functioning, role difficulties, mental health, and driving. It is often used in clinical settings to track the progression of eye diseases, evaluate treatment outcomes, or compare the quality of life between different patient groups. A higher score indicates better visual function and quality of life, meaning the patient experiences fewer difficulties and less impairment in daily activities due to vision problems. Therefore, higher scores are better in this context.
Measured: [set the tissue sampling date at the begin] Enrollment, before the transplantation, Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limbal Stem Cells DeficiencyStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700655
- Sponsor's protocol ID
- 2021GXB01-4
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on Co-transplantation of Autologous Limbal Stem Cells and Corneal Stromal Stem Cells to Repair Corneal Injury: an Open-label, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06700655
- Acronym / sponsor ID
- 2021GXB01-4
- Conditions
- Limbal Stem Cells Deficiency
- Keywords
- Limbal stem cell, Limbal stem cells deficiency, Corneal stromal stem cells, Corneal transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 22 Nov 2024 (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.
This study aims to: 1) verify the feasibility of treating limbal stem cell deficiency (LSCD) caused by chemical injury with autologous limbal stem cell transplantation combined with corneal stromal stem cell transplantation; 2) evaluate the corneal healing patterns following autologous stem cell transplantation; and 3) establish a clinical intervention protocol based on autologous corneal stem cell transplantation. Sixty cases of single-eye LSCD were included.
Detailed description
Limbal Stem Cells (LSCs) are the sole source of corneal epithelial self-renewal and play a critical role in maintaining corneal transparency. Chemical or physical injury to the eye and inflammation can lead to limbal stem cell deficiency (LSCD), accompanied by a series of pathological changes, such as irreversible fibrosis of corneal stromal cells and neovascularization, ultimately resulting in blindness. The fundamental solution for such diseases is the replenishment of LSCs to reconstruct a functional cornea. However, traditional treatment methods, such as corneal transplantation, face bottlenecks, including a severe shortage of corneal donors and the risk of immune rejection. Additionally, donor corneas do not contain LSCs, making it impossible to reconstruct the patient's limbal region, resulting in poor long-term efficacy.
In 2015, autologous LSCs were approved by the European Union as a commercial stem cell product for treating patients with chemically induced LSCD. However, LSCD patients are often accompanied by damage to the corneal stroma; while LSC transplantation can restore the limbal region and corneal epithelium, it cannot repair stromal opacities. Research indicates that transplantation of corneal stromal stem cells can reconstruct organized collagen structures and restore stromal transparency. Over the past decade, clinical studies using LSCs and corneal stromal stem cells to treat LSCD patients have been conducted in multiple countries, demonstrating the safety and efficacy of these stem cell therapies for corneal blindness.
Based on these findings above, the investigators have established a serum-free, carrier-free culture system that enables efficient and uniform in vitro expansion of functional LSCs and corneal stromal stem cells. By obtaining a 2 x 5 mm limbal tissue sample from the healthy eye of the patient, the investigators can acquire a sufficient number of cells for transplantation. Preclinical studies have confirmed that the expanded cells are effective and safe for treating LSCD animal models. This study aims to use autologous LSCs combined with corneal stromal stem cell transplantation to treat patients with unilateral LSCD, restoring their corneal transparency and visual function. This approach provides a novel treatment method for patients and promotes the application of stem cell regenerative medicine for the treatment of corneal blindness in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cornea limbal stem cell transplantation group | Experimental | Biological: Cornea limbal stem cell transplantation groupThe corneal limbal tissue (2mm x 5mm) was harvested from the patient's healthy eye, and ex vivo amplification was performed to obtain an adequate quantity of transplantable corneal limbal stem cells The patient was followed up and re-examined for 2 years postoperatively. |
| Cornea limbal stem cell transplantation combined corneal stromal stem cell group | Experimental | Biological: Cornea limbal stem cell transplantation combined corneal stromal stem cell groupThe corneal limbal tissue (2mm x 5mm) was harvested from the patient's healthy eye, and ex vivo amplification was performed to obtain an adequate quantity of transplantable corneal limbal stem cells and corneal stromal stem cells. The patient was followed up and re-examined for 2 years postoperatively. |
| Corneal transplantation group | Active comparator | Procedure: Corneal transplantationThe patient awaited allogeneic corneal donation and underwent corneal transplantation surgery. Postoperatively, the patient was followed up and re-examined for 2 years. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chemical injury from acid or alkali exposure
- Extensive limbal stem cell deficiency (greater than 180 degrees), with corneal stromal opacity not exceeding a depth of 250 μm
- Corneal epithelial conjunctivalization and fibrosis, with neovascularization extending into more than half of the quadrants
- Unilateral ocular involvement, with normal limbal stem cell function in the contralateral healthy eye
- No significant improvement in ocular surface signs and symptoms after pharmacological or surgical interventions, stable for over three months
Key exclusion criteria (19 listed)
- Bilateral corneal stem cell deficiency, such as in Stevens-Johnson syndrome, ocular cicatricial pemphigoid, or congenital aniridia
- Subclinical limbal stem cell deficiency in the contralateral eye
- Signs of corneal endothelial decompensation, such as corneal bullae or corneal edema
- Presence of infectious inflammation on the ocular surface
- Severe dry eye
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 |
|---|---|---|
| Cornea limbal stem cell transplantation groupThe corneal limbal tissue (2mm x 5mm) was harvested from the patient's healthy eye, and ex vivo amplification was performed to obtain an adequate quantity of transplantable corneal limbal stem cells. | Biological | Cornea limbal stem cell transplantation group |
| Corneal transplantationThe patient awaited allogeneic corneal donation and underwent corneal transplantation surgery. | Procedure or surgery | Corneal transplantation group |
| Cornea limbal stem cell transplantation combined corneal stromal stem cell groupThe corneal limbal tissue (2mm x 5mm) was harvested from the patient's healthy eye, and ex vivo amplification was performed to obtain an adequate quantity of transplantable corneal limbal stem cells and corneal stromal stem cells. | Biological | Cornea limbal stem cell transplantation combined corneal stromal stem cell group |
Primary outcome
Vision
Time frame: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
The patient should initially be positioned 5 meters from the visual acuity chart in a well-lit environment. Each eye is tested separately (the non-tested eye should be completely covered with an eye patch without applying pressure on the eyeball). During the test, the patient first views the largest line on the chart. If they can identify it, they proceed from top to bottom, viewing progressively smaller lines until the smallest identifiable line is determined. The patient should not spend more than 5 seconds reading each character.
8 secondary outcomes
Efficacy Scoring
Time frame: [set the corneal limbal tissue sampling date at the begin] First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
Ocular adverse event evaluation
Time frame: [set the corneal limbal tissue sampling date at the begin] before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
ophthalmic examination（slit-lamp）
Time frame: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
cornea confocal
Time frame: [set the tissue sampling date at the begin] Enrollment, before the transplantation, Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
corneal topography
Time frame: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
Optical Coherence Tomography
Time frame: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
anterior segment photography
Time frame: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
VFQ-25 questionnaire
Time frame: [set the tissue sampling date at the begin] Enrollment, before the transplantation, Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cornea limbal stem cell transplantation group, Corneal transplantation and Cornea limbal stem cell transplantation combined corneal stromal stem cell group in people with Limbal Stem Cells Deficiency, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 19 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: opening soon, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Ouyang, researcher (+86 13825030822, Ouyhong3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vision (time frame: [set the tissue sampling date at the begin] Enrollment, before the transplantation, First follow-up (Day 32), Second follow-up (Day 48), Third follow-up (Day 108), Fourth follow-up (6 months), Fifth follow-up (1 year), Sixth follow-up (2 years)). 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 22 Nov 2024.