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Cultivated Autologous Oral Mucosal Epithelial Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03943797
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
David Hui-Kang Ma, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Limbal Stem Cell Deficiency Biological: Cultivated oral mucosal epithelial cell transplantation Phase 1

Detailed Description:

When corneal epithelial stem cells are destroyed by severe trauma such as burn or autoimmune diseases, poor regeneration of corneal epithelium, persistent inflammatory reaction, neovascular ingrowth, and conjunctivalization may ensue, and seriously reduce the vision. In treating the diseased eye, when the other eye is healthy, limbal tissue containing corneal epithelial stem cells can be harvested for direct tissue transplantation, or ex vivo cultivation and expansion for several days before transplantation.

For patients with bilaterally damaged eyes, rejection rate in non-HLA matched allograft limbal stem cell transplantation is very high, in addition, adverse reaction to long-term immunosuppressive therapy may be life-threatening. Therefore, in 2004 Japanese researchers first proposed a novel technique to treat ocular surface diseases using cultivated autologous oral mucosal epithelial transplantation (COMET). From 2006 to 2009, investigators have also conducted a Phase I clinical trial approved by Taiwan FDA. In that Phase I trial, investigators have demonstrated efficacy of such cell therapy in promoting wound healing in patients with severe ocular surface burns (Ma DHK et al. Eye 2009; 23: 1442- 1450). Investigators have also identify long-term persistence of transplanted oral mucosal epithelial cells in the cornea (Chen HCJ et al. IOVS 2009;50:4660-4668), justifying this innovative surgical procedure as an effective alternative treatment modality.

However, in previous protocol, animal products such as fetal calf serum and 3T3 cell culture were used, raising the biosafety concern. For this, recently investigators have developed an animal ingredient-free cell culture protocol, and our protocol can meet the GTP standards, and has obtained the accreditation by Taiwan FDA and affiliated institutes. Therefore, the focus of current Phase Ib trial is to confirm the feasibility and safety of following items:

  1. To produce cell culture product not containing animal ingredient, so as to avoid zoonoses. The oral mucosal epithelial cells thus cultured are used for treating ocular surface diseases with limbal stem cell deficiency.
  2. To reduce recurrence of corneal neovascularization after COMET, Bevacizumab (Avastin) is injected locally, so as to improve corneal transparency and visual acuity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cultivated Autologous Oral Mucosal Epithelial Transplantation for the Treatment of Ocular Surface Diseases: A Clinical Study
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Cultivated oral mucosal epithelial cell transplantation
Cell therapy for treating severe limbal stem cell deficiency using cultivated autologous oral mucosal epithelial cells.
Biological: Cultivated oral mucosal epithelial cell transplantation
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




Primary Outcome Measures :
  1. The proportion of study specific AE [ Time Frame: 12 months ]
    The tolerance and safety



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943797


Contacts
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Contact: David Hui-Kang Ma, MD, PhD 03-328-1200 ext 7840 davidhkma@yahoo.com
Contact: Zheng Hua Huang, MSc 03-328-1200 ext 7840 a513115@yahoo.com.tw

Locations
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Taiwan
Core Laboratory for Cell Therapy, Veterans General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Su-Zeng Chen, Master    886-2-28712121 ext 8455    jennifercatty+ctcl@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: David Hui-Kang Ma, MD, PhD Chang Gung Memorial Hospital

Publications of Results:

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Responsible Party: David Hui-Kang Ma, Attending Physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03943797    
Obsolete Identifiers: NCT02739113
Other Study ID Numbers: 101CONS12640
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Hui-Kang Ma, Chang Gung Memorial Hospital:
Oral mucosal epithelial cells
Cornea
Amniotic membrane
Collagenase