Derivation of New Human Embryonic Stem Cell Lines Lines for Clinical Use

Human embryonic stem cells (hESCs) are isolated from the early human embryo and have the capability to proliferate indefinitely in culture and to develop into nearly every cell of the human body. Therefore, hESCs may serve as a renewable unlimited source of cells for transplantation therapy. Because of the use of animal products in their derivation, and due to the lack of appropriate quality and process controls in the manufacturing of existing cell lines worldwide, existing hESC lines are not suitable for utilization in transplantation therapy. Our objective is to derive several new hESC lines that will be suitable for clinical trials. The investigators plan on deriving the new hESC lines utilizing only FDA-approved raw materials in a non-animal culture system. They will be produced entirely under GMP conditions, using appropriately documented procedures and analytical methods, completely safety tested, and screened for infectious and adventitious agents.

NCT Number	NCT00353197
Lead Sponsor	Hadassah Medical Organization
Conditions	Infertility
Enrollment	80 participants
Start Date	2002-07-07
Primary Completion	2030-12 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2025-03-05