Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation

Limbal Stem Cell Deficiency Clinical Trial

Official title:

An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT02149732
• Other study ID #: COMET trial
• Secondary ID: MKKim
• Status: Available
• Phase: Phase 1/Phase 2
• First received: May 14, 2014
• Last updated: April 18, 2016
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: Mee Kum Kim, MD, PhD
• Phone: 82-10-6277-0798
• Email: kmk9[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Expanded Access

Clinical Trial Summary

To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.

Description:

Interventional study for treatment of patients with cicatricial change of ocular surface.

Single Group: (Limbal stem cell deficiency group)

Treatment: After cultivating autologous Oral mucosal epithelial cell sheet, the sheet will be transplanted to the ocular surface of the patients

Inclusion criteria

1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea

2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment

3. patient who agree this clinical trial

4. patient with the eyes in which best corrected visual acuity is less than counting finger

5. patient who is older than sixteen year old

Exclusion criteria

1. patient who has relevant corneal transparency

2. patient who is on the pregnancy or has a plan of pregnancy within 1 year

3. patient who has corneal infection

4. patient who has diagnosis of HBV, HCV, HIV, syphilis

5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease

6. patient who has malignancy

7. patient who shows hypersensitivity to bovine protein.

Primary outcome Epithelization of corneal surface (6 months after cell sheet transplantation)

Secondary outcome Visual acuity (6 months after cell sheet transplantation)

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea

2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment

3. patient who agree this clinical trial

4. patient with the eyes in which best corrected visual acuity is less than counting finger

5. patient who is older than sixteen year old

Exclusion Criteria:

1. patient who has relevant corneal transparency

2. patient who is on the pregnancy or has a plan of pregnancy within 1 year

3. patient who has corneal infection

4. patient who has diagnosis of HBV, HCV, HIV, syphilis

5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease

6. patient who has malignancy

7. patient who shows hypersensitivity to bovine protein.

Study Design

N/A

Related Conditions & MeSH terms

• Chemical Burn
• Limbal Stem Cell Deficiency
• Ocular Cicatricial Pemphigoid
• Stevens-Johnson Syndrome

Intervention

Biological:
• cultivated oral mucosal epithelial sheet transplantation
Autologous cultivated oral mucosal epithelial cell sheet transplantation using oral mucosal adult stem cells in the patients with intractable corneal limbal deficiency

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National Unversity Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Nishida K, Yamato M, Hayashida Y, Watanabe K, Yamamoto K, Adachi E, Nagai S, Kikuchi A, Maeda N, Watanabe H, Okano T, Tano Y. Corneal reconstruction with tissue-engineered cell sheets composed of autologous oral mucosal epithelium. N Engl J Med. 2004 Sep 16;351(12):1187-96. — View Citation