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Clinical Trials in Israel / NCT00353197
Recruiting Observational

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

NCT00353197 · tracked via the Priya Life Science Israel tracker
Sponsor
Hadassah Medical Organization
Phase
Observational
Started
2002-07-07
Last updated
2025-03-05

Condition(s) studied

Infertility

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Couple has embryos derived through IVF that they wish to donate to research. * Couple has finished building their family. * Couple has them stored in liquid nitrogen for \> or = to 5 years. * Couple will submit to an interview, blood tests, and physical exam by a physician. * Couple will give informed consent and will consent to have their medical history examined by the research group. Exclusion Criteria: * Couple has not finished building their family. * Couple has embryos but they have not been stored for \> or = to 5 years. * Couple will not submit to an interview, blood tests, or physical exam by a physician. * Couple refuse to give informed consent, or will not consent to have their medical history examined by the research group. * Couple has spent an extended period of time in exclusion countries (HIV or vCJD risk). * Couple tests positive for exclusion viruses (as listed in the Informed Consent).

Trial sites (1)

FacilityCityRegionStatus
Hadassah Medical Organization Jerusalem Israel Recruiting

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Other trials for the same condition

The Derivation of Human Embryonic Stem Cell Lines From PGD Embryos Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00353197 on ClinicalTrials.gov ↗ ← All trials in Israel