CAOMECS Transplantation to Patients with LSCD

• Research type

  Research Study

• Full title

  MULTICENTER STUDY OF CULTURED AUTOLOGOUS ORAL MUCOSAL EPITHELIAL CELL-SHEET (CAOMECS) TRANSPLANTATION TO PATIENTS WITH TOTAL LIMBAL STEM CELL DEFICIENCY

• IRAS ID

  90496

• Contact name

  Harminder Dua

• Sponsor organisation

  Cellseed France S.A.R.L.

• Eudract number

  2011-000598-30

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Limbal stem cells, located in the epithelium of the eye, are responsible for maintaining the health of the cornea. Certain diseases or injuries to the eyes can lead to a deficiency of these cells resulting in corneal clouding with decreased vision, photophobia, pain, tearing, and chronic inflammation. This is called Limbal Stem Cell Deficiency (LSCD). Current treatments include increasing the ocular surface moisture with lubrication, bandage contact lenses and eyedrops; however these measures only relieve the symptoms and do not correct the actual problem.More recent therapy is to transplant healthy limbal tissue from a patient's unaffected eye into the diseased eye. However, due to the removal of large segments of limbal tissue, this method carries the risk of creating LSCD to the healthy eye. In patients with unilateral or partial bilateral LSCD, limbal transplantation using the patient??s own cells cultivated on a supportive ??scaffold?? of human tissue, like human amniotic membrane, collagen or fibrin gel, can be used to reconstruct the ocular surface. However little is known about the integration of the ??scaffold?? carriers into the patient??s natural eye tissues and they may interfere with the grafting processes. In patients with bilateral total LSCD, limbal transplantation from tissue that is not the patient??s own tissue is required. However, this method poses the risk of rejection and therefore need long-term systemic immunosuppression. Alternative sources of ??same patient?? tissue for ocular surface reconstruction that may functionally replace the corneal epithelium have been considered. Several studies suggest that the transplantation of cultivated autologous oral mucosal epithelial cell-sheet (CAOMECS) is a feasible alternative and this study is designed to evaluate this in adults and children.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  11/EM/0455

• Date of REC Opinion

  6 Mar 2012

• REC opinion

  Further Information Favourable Opinion