Cultivated Autologous Oral Mucosal Epithelial Transplantation

NCT03943797 | Unknown Phase 1 DMC

• 1 other identifier: 101CONS12640
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral mucosal epithelial cells; Cornea; Amniotic membrane; Collagenase

Outcome Measures

Primary Outcomes (1)

• The proportion of study specific AE

  The tolerance and safety

  12 months

Study Arms (1)

Cultivated oral mucosal epithelial cell transplantation

EXPERIMENTAL

Cell therapy for treating severe limbal stem cell deficiency using cultivated autologous oral mucosal epithelial cells.

Biological: Cultivated oral mucosal epithelial cell transplantation

Interventions

Cultivated oral mucosal epithelial cell transplantation BIOLOGICAL

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

Cultivated oral mucosal epithelial cell transplantation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe corneal epithelial deficiency
• Having favorable prognosis potential
• Normal of the intraocular pressure
• Normal of the light perception for the optic nerve
• No retinal diseases for the inflicted eyes
• No severe dry eye

You may not qualify if:

• Having unfavorable prognosis potential
• Severe systemic disorders
• Unable to use daily vision
• Mentally retarded to execute permit on surgery
• Pregnant woman

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Core Laboratory for Cell Therapy, Veterans General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (13)

• Chen HC, Chen HL, Lai JY, Chen CC, Tsai YJ, Kuo MT, Chu PH, Sun CC, Chen JK, Ma DH. Persistence of transplanted oral mucosal epithelial cells in human cornea. Invest Ophthalmol Vis Sci. 2009 Oct;50(10):4660-8. doi: 10.1167/iovs.09-3377. Epub 2009 May 20.

  PMID: 19458337 RESULT

• Chen HC, Yeh LK, Tsai YJ, Lai CH, Chen CC, Lai JY, Sun CC, Chang G, Hwang TL, Chen JK, Ma DH. Expression of angiogenesis-related factors in human corneas after cultivated oral mucosal epithelial transplantation. Invest Ophthalmol Vis Sci. 2012 Aug 17;53(9):5615-23. doi: 10.1167/iovs.11-9293.

  PMID: 22850415 RESULT

• Inatomi T, Nakamura T, Koizumi N, Sotozono C, Yokoi N, Kinoshita S. Midterm results on ocular surface reconstruction using cultivated autologous oral mucosal epithelial transplantation. Am J Ophthalmol. 2006 Feb;141(2):267-275. doi: 10.1016/j.ajo.2005.09.003.

  PMID: 16458679 RESULT

• Inatomi T, Nakamura T, Kojyo M, Koizumi N, Sotozono C, Kinoshita S. Ocular surface reconstruction with combination of cultivated autologous oral mucosal epithelial transplantation and penetrating keratoplasty. Am J Ophthalmol. 2006 Nov;142(5):757-64. doi: 10.1016/j.ajo.2006.06.004. Epub 2006 Sep 20.

  PMID: 16989763 RESULT

• Li W, Sabater AL, Chen YT, Hayashida Y, Chen SY, He H, Tseng SC. A novel method of isolation, preservation, and expansion of human corneal endothelial cells. Invest Ophthalmol Vis Sci. 2007 Feb;48(2):614-20. doi: 10.1167/iovs.06-1126.

  PMID: 17251457 RESULT

• Ma DH, Kuo MT, Tsai YJ, Chen HC, Chen XL, Wang SF, Li L, Hsiao CH, Lin KK. Transplantation of cultivated oral mucosal epithelial cells for severe corneal burn. Eye (Lond). 2009 Jun;23(6):1442-50. doi: 10.1038/eye.2009.60. Epub 2009 Apr 17.

  PMID: 19373264 RESULT

• Nakamura T, Inatomi T, Sotozono C, Amemiya T, Kanamura N, Kinoshita S. Transplantation of cultivated autologous oral mucosal epithelial cells in patients with severe ocular surface disorders. Br J Ophthalmol. 2004 Oct;88(10):1280-4. doi: 10.1136/bjo.2003.038497.

  PMID: 15377551 RESULT

• Nakamura T, Takeda K, Inatomi T, Sotozono C, Kinoshita S. Long-term results of autologous cultivated oral mucosal epithelial transplantation in the scar phase of severe ocular surface disorders. Br J Ophthalmol. 2011 Jul;95(7):942-6. doi: 10.1136/bjo.2010.188714. Epub 2010 Nov 19.

  PMID: 21097786 RESULT

• Petsoglou C, Balaggan KS, Dart JK, Bunce C, Xing W, Ali RR, Tuft SJ. Subconjunctival bevacizumab induces regression of corneal neovascularisation: a pilot randomised placebo-controlled double-masked trial. Br J Ophthalmol. 2013 Jan;97(1):28-32. doi: 10.1136/bjophthalmol-2012-302137. Epub 2012 Oct 20.

  PMID: 23087419 RESULT

• Satake Y, Higa K, Tsubota K, Shimazaki J. Long-term outcome of cultivated oral mucosal epithelial sheet transplantation in treatment of total limbal stem cell deficiency. Ophthalmology. 2011 Aug;118(8):1524-30. doi: 10.1016/j.ophtha.2011.01.039. Epub 2011 May 14.

  PMID: 21571372 RESULT

• Takeda K, Nakamura T, Inatomi T, Sotozono C, Watanabe A, Kinoshita S. Ocular surface reconstruction using the combination of autologous cultivated oral mucosal epithelial transplantation and eyelid surgery for severe ocular surface disease. Am J Ophthalmol. 2011 Aug;152(2):195-201.e1. doi: 10.1016/j.ajo.2011.01.046. Epub 2011 Jun 8.

  PMID: 21652025 RESULT

• Hsueh YJ, Huang SF, Lai JY, Ma SC, Chen HC, Wu SE, Wang TK, Sun CC, Ma KS, Chen JK, Lai CH, Ma DH. Preservation of epithelial progenitor cells from collagenase-digested oral mucosa during ex vivo cultivation. Sci Rep. 2016 Nov 8;6:36266. doi: 10.1038/srep36266.

  PMID: 27824126 RESULT

• Ma DH, Hsueh YJ, Ma KS, Tsai YJ, Huang SF, Chen HC, Sun CC, Kuo MT, Chao AS, Lai JY. Long-term survival of cultivated oral mucosal epithelial cells in human cornea: generating cell sheets using an animal product-free culture protocol. Stem Cell Res Ther. 2021 Oct 7;12(1):524. doi: 10.1186/s13287-021-02564-7.

  PMID: 34620226 DERIVED

MeSH Terms

Conditions

Limbal Stem Cell Deficiency; Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• David Hui-Kang Ma, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Hui-Kang Ma, MD, PhD

CONTACT

03-328-1200; davidhkma@yahoo.com

Zheng Hua Huang, MSc

CONTACT

03-328-1200; a513115@yahoo.com.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: Attending Physician

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 9, 2019
• Study Start: March 1, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 13, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)