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Cultivated Autologous Oral Mucosal Epithelial Transplantation for the Treatment of Ocular Surface Diseases

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ClinicalTrials.gov Identifier: NCT02739113
Recruitment Status : Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : April 14, 2016
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 Phase 1 Phase 2

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. Invest Ophthalmol Vis Sci 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 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 : 30 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: Phase Ib Clinical Trial
Study Start Date : January 2016
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  1. Re-epithelialization of cornea [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Regression of corneal neovascularization: Final averaged length of corneal blood vessels less than 35% total corneal area occupied by blood vessels. [ Time Frame: 6-12 months ]
  2. Improvement of best corrected visual acuity: At least 2 lines of improvement. [ Time Frame: 3 months ]
  3. Improvement in corneal clarity (slit lamp examination): Improvement at least one grade. [ Time Frame: 3 months ]


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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): NCT02739113


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: NCT02739113     History of Changes
Other Study ID Numbers: 104-7758C
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by David Hui-Kang Ma, Chang Gung Memorial Hospital:
OMECs
Cornea
Amniotic membrane
Collagenase