Unilateral Limbal Stem Cell Insufficiency Clinical Trial
Official title:
Phase 1 Study of Cornea Stem Cells Cultured on Amniotic Membrane Transplanted on Patients Suffering From Corneal Stem Cell Insufficiency
Name of the project：The application of cornea stem cells cultured on amniotic membrane in
patients suffering from corneal stem cell insufficiency
Purpose: To develop the technique of using ex vivo expansion of autologous limbal stem cell
cultured on amniotic membrane for treatment of patients suffering from limbal stem cell
insufficiency
Materials and Methods:
1. Patients suffering from unilateral limbal stem cell insufficiency will be chosen. Make
sure those volunteers understand the benefits and risk factors of the operation.
2. Prepare human amniotic membrane, and culture the membrane at37°C，5% CO2，95% room air.
3. One month before transplantation, take 1-2mm2 of limbal tissues from the healthy eye,
and culture the limbal tissue on amniotic membrane with 1.5 ml supplemental hormonal
epithelial medium (in 5%的 fetal calf serum)
4. Keep culturing the cells in Dulbecco's modified Eagle's medium/Ham's F12 (1:1 ratio),
added with 5 % dimethyl sulfoxide, 2 mg/ml human epidermal growth factor ,5 ug/ml
insulin, 0.5 ug/ml hydrocortisone, 50 ug/ml gentamicin, 1.25 ug/ml amphotericin B, 5%
autoserum。Two to three weeks later, transplantation will be performed after the cells
reaches 2-3 cm2
5. Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic
membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens
after operation, and apply topical antibiotics and steroids.
6. Postoperatively, observe the patients for one week. After discharge, follow up the
patients one week, two week, one month, two months, three months, six months and one
year later.
7. Pictures will be taken and the extent of corneal epithelium regeneration, visual
acuity, and complications will be recorded during follow-up visits.
8. The investigators plan to collect 20 patients from 1 July,2007 to 30, June, 2010
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment