Synthetic Substitute for human-amniotic membrane for Limbal Stem Cell Transplant

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“Research Innovation to Clinic” Support for Synthetic Substitute for human-amniotic membrane for Limbal Stem Cell Transplant

A Leading Eye Institute from India engaged Nextvel to help with initial regulatory strategy and advice for a novel Synthetic Substitute for human-amniotic membrane for Limbal Stem Cell Transplant. The Institute had collaborated with a UK University on this project.

Nextvel supported the Institute with all the required steps including regulatory clearances and the Phase I clinical trial. All approvals from the government were obtained before conducting the trial and the study was successfully concluded with this unique product and results were published in British Medical Journal for Ophthalmology. The feedback from the study with respect to the design of the product is being implemented so that the next phase of the clinical trial can be done in many subjects.

The novel product is a synthetic scaffold which supports limbal stem cell growth and transfer to the ocular surface in a predictable manner. Vision improvement was noted in 60% of the subjects. The subjects enrolled had low visual acuity.

In this study for the first time the Synthetic membrane was used as a carrier for transplanting limbal cells to the ocular surface of human subjects for the treatment of limbal stem cell deficiency. In all patients, an intact ocular surface was regenerated by 3 months and vision improved in 60% of patients. There were no safety concerns and the synthetic membrane degraded as predicted.

The material has the potential to replace the human amniotic membrane in the future, thus making the technique of corneal surface regeneration easily accessible.