Overview

This trial is active, not recruiting.

Condition limbal stem cell deficiency
Treatment cultivated oral mucosal epithelial cell
Phase phase 1/phase 2
Sponsor Chang Gung Memorial Hospital
Start date January 2016
End date March 2016
Trial size 30 participants
Trial identifier NCT02739113, 104-7758C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cultivated oral mucosal epithelial cell transplantation (COMET) : To treat severe limbal stem cell deficiency using cultivated autologous oral mucosal epithelial cell transplantation.
cultivated oral mucosal epithelial cell
Cell therapy for treating severe limbal stem cell deficiency using cultivated autologous oral mucosal epithelial cells.

Primary Outcomes

Measure
Re-epithelialization of cornea
time frame: 21 days

Secondary Outcomes

Measure
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
Improvement of best corrected visual acuity: At least 2 lines of improvement.
time frame: 3 months
Improvement in corneal clarity (slit lamp examination): Improvement at least one grade.
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Cultivated Autologous Oral Mucosal Epithelial Transplantation for the Treatment of Ocular Surface Diseases: Phase Ib Clinical Trial
Principal investigator David Hui-Kang Ma, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Chang Gung Memorial Hospital.