NCT03015779

Brief Summary

The aim of this trials investigates the therapeutic effects of application autologous oral mucosal epithelial cell sheets in the treatment of limbal stem cell deficiency disease.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

January 5, 2017

Last Update Submit

January 8, 2017

Conditions

Limbal Stem Cell Deficiency

Outcome Measures

Primary Outcomes (1)

  • The area of reepithelialization of corneal epithelium

    The preoperative status of the eye will be recorded on the basis of clinical drawings and pre-and post-operative photographs. These pictures will be sent to two corneal experts in order to evaluate the results. Judgement criterion: the results will be tested with a slit lamp: Normal: no epithelial loss; Mild: the area of epithelial loss \<1/3; Moderate: the area of epithelial loss \>1/3 \<2/3; Severe: the area of epithelial loss\> 2/3

    3 months

Secondary Outcomes (2)

  • Improvement of best correct visual acuity

    one year

  • Decrease of corneal neovascularization

    one year

Study Arms (1)

experimental group

EXPERIMENTAL

cultured autologous oral mucosal epithelial cell sheet

Other: cultured autologous oral mucosal epithelial cell sheet

Interventions

cultured autologous oral mucosal epithelial cell sheetOTHER

a prospective study,Before and after self control

experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged\>=18 years old
  • Normal intraocular pressure
  • Normal Eyelid
  • No cataract and retinal disease
  • No ulcers and tumor in the mouth

You may not qualify if:

  • Severe Systemic infection
  • History of acute phase of ocular and oral inflammation
  • History of hyper sensibility or allergy to antibiotics or serum
  • Women who are or may be pregnant
  • Patients with infectious diseases
  • Patients with other complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zhang M, Zheng Y, Yao T, Wang L, Yu H, Wang Z. Impact of Smoking on the Efficacy of Human Autologous Oral Mucosal Epithelial Cell Sheet Transplantation for Treating Limbal Stem Cell Deficiency. Stem Cells Int. 2026 Jan 5;2026:3769266. doi: 10.1155/sci/3769266. eCollection 2026.

    PMID: 41503585DERIVED

MeSH Terms

Conditions

Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 10, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

January 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share