Creating new human embryonic stem cell lines for clinical use
Official title: The Derivation of New Human Embryonic Stem Cell Lines for Clinical Use
Run by Hadassah Medical Organization · NCT00353197 · Data updated 2026-11-12
This study is trying to create new human embryonic stem cell lines from donated embryos to see if they can be safely used in future treatments for conditions that need regenerative medicine and transplants.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Status | Recruiting |
| Started | July 7, 2002 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | March 5, 2025 |
| Trial ID | NCT00353197 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are couples who have completed their family and have embryos stored for at least five years that they wish to donate for research.
✕Probably not a fit
Patients who have not completed their family or whose embryos have not been stored for the required duration will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to derive new human embryonic stem cell (hESC) lines from early human embryos donated by couples who have completed their families. The hESCs will be cultivated using FDA-approved materials in a non-animal culture system, ensuring compliance with Good Manufacturing Practices (GMP). The derived cell lines will undergo rigorous safety testing and screening for infectious agents to ensure their suitability for future clinical applications, particularly in regenerative medicine and transplantation therapies.
Why it matters
Potential benefit: If successful, this could provide a renewable source of safe and effective stem cells for treating various degenerative diseases.
How similar studies have gone: Other studies have successfully derived hESC lines, but this approach emphasizes the use of FDA-approved materials and GMP conditions, making it a novel contribution to the field.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Hadassah Medical Organization
Jerusalem, Israel Recruiting
Study contacts
- Principal investigator: Benjamin E. Reubinoff, M.D. PhD. — Hadassah Medical Organization
- Study coordinator: Benjamin E. Reubinoff, M.D. PhD.
- Email: reubinof@md.huji.ac.il
- Phone: 011-972-2-677-7111
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.