The Improvement of Limbal Epithelial Culture Technique by Using Collagenase to Isolate Limbal Stem Cells

NCT02202642 | Unknown Phase 1 DMC

• 1 other identifier: 201007032D
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment of patients suffering from unilateral limbal stem cell insufficiency based on the concept of "limbal stem cells need special cell-cell contact and cell-extracellular matrix interaction to support their survival".

Conditions

Alkaline Chemical Burn Of Cornea And Conjunctival Sac; Acid Chemical Burn Of Cornea And Conjunctival Sac; Benign Mucous Membrane Pemphigoid With Ocular Involvement

Outcome Measures

Primary Outcomes (1)

• Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment.

  Nine to twelve days later after successful culture, transplantation will be performed after the cells diameter reaches 1.5-2.0 cm compact confluent epithelial sheets without evidence of contamination.

  12 months

Study Arms (1)

limbal stem cells

EXPERIMENTAL

Using collagenase to isolate limbal stem cells and improve the technique of ex vivo expansion of limbal stem cells for the treatment of patients suffering from unilateral limbal stem cell insufficiency based on the concept of "limbal stem cells need special cell-cell contact and cell-extracellular matrix interaction to support their survival"

Procedure: collagenase

Interventions

collagenase PROCEDURE

Cultured limbal stem cells transplantation

limbal stem cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: between 18-70 years old.
• Lesion eye should have limbal insufficiency more than 180 degrees.
• Lesion eye should have recurrent corneal erosions, corneal neovascularisation and poor vision caused by limbal insufficiency.
• The symptoms should be more than 1/2 year, and have no possibility of improvement by medical treatment.
• The patients will to received the operation and the long term post- operative follow-up.
• The patients are not infected by AIDS, hepatitis B/C , and willing to received the associated examinations.
• The patients does not plan to be pregnant from the day of cell culture and transplantation for 1 year. They also agree to receive the pregnant test.
• The condition of cell culture from the 1st to the clinical trial is successful.

You may not qualify if:

• Bilateral limbal insufficiency.
• No recurrent corneal erosion, corneal neovascularisation or poor vision was found due to limbal insufficiency. If corneal neovascularisation was found deeper than the anterior 1/2 of corneal stroma, or corneal thickness was less than 200 um evaluated by anterior segment OCT and ultrasound pachymetry, the patients should be excluded from the operation criteria. If corneal thickness becomes thicker, the patients can be enrolled for operation.
• About corneal sedation, if the value checked by Cocet-Bonnet esthesiometer is less than 5 mm, the patients should be excluded from operation.
• The condition can be improved by medication, or resolve spontaneously.
• Post-operative follow up is less than 1/2 year
• The patient can't receive long term postoperative follow up
• No light perception, or can be expected to have very poor prognosis
• If the intraocular pressure was more than 21 mmHg under necessary glaucoma surgery and anti-glaucoma medication, or optic disc cupping was more than 90%, or visual field was found to have severe defects, the patients were excluded from the clinical trial.
• Severe lagophthalmos or trichiasis, and does not received blepharoplasty.
• Severe dry eye syndrome. Those patients with schirmer's test result less than 1 mm should be excluded.
• If the cells in the first part of the clinical trial can't be successfully cultivated, the patients should be excluded. If the patients insisted to received further treatment, they can be enrolled 3 months later.
• Pregnancy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Wei-Li Chen

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Interventions

Collagenases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Study Officials

• Wei Li Chen, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Li Chen, MD, PhD

CONTACT

886-2-23123456; chenweili@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wei-Li Chen/Assistant Professor, National Taiwan University, Department of Ophthalmology.

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: July 29, 2014
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 29, 2014

Record last verified: 2014-07

Locations

TW (1)