NCT06700655

Brief 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 3) establish a clinical intervention protocol based on autologous corneal stem cell transplantation. Sixty cases of single-eye LSCD were included.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
35mo left

Started Dec 2024

Longer than P75 for phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Dec 2024Mar 2029

First Submitted

Initial submission to the registry

November 17, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

November 17, 2024

Last Update Submit

November 20, 2024

Conditions

Limbal Stem Cells Deficiency

Keywords

Limbal stem cellLimbal stem cells deficiencyCorneal stromal stem cellsCorneal transplantation

Outcome Measures

Primary Outcomes (1)

  • 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.

    [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

    [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

    [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）

    [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

    [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

    [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)

  • +3 more secondary outcomes

Other Outcomes (11)

  • Lung Condition

    [set the tissue sampling date at the begin] Enrollment, Sixth follow-up (2 years)

  • Cardiac Function

    [set the tissue sampling date at the begin] Enrollment, Sixth follow-up (2 years)

  • Number of participants with abnormal hematologic parameters as assessed by standard criteria (the normal scale on the report)

    [set the tissue sampling date at the begin] Enrollment, before the transplantation, Second follow-up (Day 48), Third follow-up (Day 108), Fifth follow-up (1 year), Sixth follow-up (2 years)

  • +8 more other outcomes

Study Arms (3)

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.

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.

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.

Procedure: Corneal transplantation

Interventions

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.

Cornea limbal stem cell transplantation group
Corneal transplantationPROCEDURE

The patient awaited allogeneic corneal donation and underwent corneal transplantation surgery.

Corneal transplantation group
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.

Cornea limbal stem cell transplantation combined corneal stromal stem cell group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Corneal Transplantation

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeTransplantation

Central Study Contacts

Hong Ouyang, researcher

CONTACT

+86 13825030822Ouyhong3@mail.sysu.edu.cn

Yuan Jin, Professor

CONTACT

+86 13825141659yuanjincornea@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2024

First Posted

November 22, 2024

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share