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

NCT02149732 | Unknown

• 2 other identifiers: COMET trialMKKim
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Limbal Stem Cell Deficiency; Stevens-johnson Syndrome; Ocular Cicatricial Pemphigoid; Chemical Burn

Keywords

Limbal stem cell deficiency; Cultivated oral mucosal cell sheet transplantation; Ocular surface reconstruction

Interventions

cultivated oral mucosal epithelial sheet transplantation BIOLOGICAL

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

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea
• patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment
• patient who agree this clinical trial
• patient with the eyes in which best corrected visual acuity is less than counting finger
• patient who is older than sixteen year old

You may not qualify if:

• patient who has relevant corneal transparency
• patient who is on the pregnancy or has a plan of pregnancy within 1 year
• patient who has corneal infection
• patient who has diagnosis of HBV, HCV, HIV, syphilis
• patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease
• patient who has malignancy
• patient who shows hypersensitivity to bovine protein.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Health & Welfare, Korea: collaborator

Study Sites (2)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

AVAILABLE

Seoul National Unversity Hospital

Seoul, Seoul, 110-744, South Korea

AVAILABLE

Related 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. doi: 10.1056/NEJMoa040455.

  PMID: 15371576 BACKGROUND

MeSH Terms

Conditions

Limbal Stem Cell Deficiency; Stevens-Johnson Syndrome; Pemphigoid, Benign Mucous Membrane; Burns, Chemical

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Conjunctival Diseases; Burns; Wounds and Injuries

Study Officials

• Mee Kum Kim, MD, PhD

  Department of Ophthalmology, Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mee Kum Kim, MD, PhD

CONTACT

82-10-6277-0798; kmk9@snu.ac.kr

Yu Jeong Kim, MD

CONTACT

82-10-2559-1377; 21cnasa@naver.com

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2014
• First Posted: May 29, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

KR (2)