Information for Potential Patients
Do you have a chemical injury to one eye?
Researchers at Massachusetts Eye and Ear (MEE) are currently enrolling patients in a corneal stem cell clinical trial. This is a study to determine the safety and feasibility of collecting stem cells from a patient’s healthy eye, cultivating those cells in a laboratory, and later transplanting them into the subject's eye that has limbal stem cell deficiency. The procedure is called cultivated autologous limbal epithelial cell (CALEC) transplantation.
This NIH-funded study is the first procedure of this kind in the United States. In this procedure, a small limbal biopsy from the healthy fellow eye will be used to expand the stem cells in a laboratory with a highly controlled technique. After 2-3 weeks, the eye with limbal stem cell deficiency will undergo reconstruction using the expanded cells. The risk to the healthy eye is minimal.
The researchers hope to show that it is possible to grow patients' own stem cells into a graft that can be safely transplanted into an injured eye. Secondarily, they hope that the transplanted graft will reduce pain and improve the scarring, cloudiness, and surface integrity of the affected eye that receives the stem cell transplant.
What are Limbal Stem Cells?
Limbal stem cells are cells that help maintain the barrier between the cornea (the clear, centrally located outermost layer of the eye) and the conjunctiva (the white areas on the sides of your eye). When limbal stem cells are absent or not functioning properly, the conjunctiva may grow over the cornea, causing vision loss. The current standard of care for limbal stem cell deficiency (LSCD) in one eye is conjunctival limbal autograft (CLAU). The CLAU procedure takes cells from the eye without LSCD and transplants them to the eye with LSCD in the same operation. The investigational CALEC graft is similar to CLAU, but different in some significant ways. During CALEC, a small amount of cells is taken from the healthy eye and transported to the laboratory where they are grown for a few weeks. After adequate growth, they are grafted into the eye with LSCD. This study will determine whether CALEC grafts are safe, feasible and effective in treating LSCD and compare the outcomes for those receiving CALEC to those receiving CLAU.
Details of the Study:
Participants enrolled in the study will be randomized to either the experimental CALEC treatment or the standard of care treatment, CLAU. There is a 67% chance of receiving the CALEC treatment versus 33% receiving CLAU during the randomization process. Patients who decide to join this research study will be asked to make 17 visits over about 20 months to MEE. Each study visit may last about two to three hours. The patients will be followed for 18 months post-operatively.
To Learn More:
Please contact either Lynette Johns, OD or Stacey Ellender, PhD for more information.
Lynette Johns, OD
Stacey Ellender, PhD
This study is listed on the ClinicalTrials.gov website and the identifier is: NCT02592330