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Cultivated Autologous Oral Mucosal Epithelial Transplantation

NCT03943797 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-08-13

No results posted yet for this study

Summary

Earlier protocol for cultivated oral mucosal epithelial transplantation (COMET) requires trypsin/EDTA to isolate epithelial cells from tissue, and uses murine 3T3 cells as feeder cells, which results in biosafety concern. This study uses collagenase instead of trypsin/EDTA to isolate epithelial cells, and does not use 3T3 cells co-culture, so as to make an animal ingredient-free cell culture product. The purpose of the study is to evaluate the feasibility of the new protocol of COMET in clinical use.

Conditions

  • Limbal Stem Cell Deficiency

Interventions

BIOLOGICAL

Cultivated oral mucosal epithelial cell transplantation

Cultivated oral mucosal epithelial cell transplantation (COMET) will be used to treat severe limbal stem cell deficiency so as to restore the integrity of corneal surface

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • David Hui-Kang Ma, MD, PhD · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943797 on ClinicalTrials.gov