Actively Recruiting
Derivation of New Human Embryonic Stem Cell Lines Lines for Clinical Use
Led by Hadassah Medical Organization · Updated on 2025-03-05
80
Participants Needed
1
Research Sites
1482 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Derivation of New Human Embryonic Stem Cell Lines Lines for Clinical Use
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hadassah Medical Organization
Jerusalem, Israel, 91120
Actively Recruiting
Research Team
B
Benjamin E. Reubinoff, M.D. PhD.
CONTACT
S
Shelly Tannenbaum, MSQA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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