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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


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

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