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

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Primary and study completion dates: Dec 2025 to Dec 2030v36
  2. 5 versions Re-verified since Aug 11, 2021, no change to tracked fieldsv31-v35
  3. Start date: Jul 2002 to Jul 7, 2002
    • Site contact updated
    v30
  4. Re-verified, no change to tracked fieldsv29
  5. Enrollment target: 40 to 80v28
Show 26 earlier versionsHide 26 earlier versions
  1. 2 versions Re-verified since Feb 24, 2019, no change to tracked fieldsv26-v27
  2. Primary and study completion dates: Dec 2020 to Dec 2025v25
  3. Re-verified, no change to tracked fieldsv24
  4. Primary and study completion dates: Dec 2018 to Dec 2020v23
  5. 2 versions Re-verified since Sep 1, 2015, no change to tracked fieldsv21-v22
  6. Primary and study completion dates: Dec 2015 to Dec 2018v20
  7. Primary and study completion dates: Dec 2014 to Dec 2015v19
  8. Primary completion date: Jul 2014 to Dec 2014v18
  9. Re-verified, no change to tracked fieldsv17
  10. Primary completion date: Jul 2013 to Jul 2014v16
  11. Primary completion date: Jul 2012 to Jul 2013
    • Study completion date: Dec 2013 to Dec 2014
    v15
  12. 2 versions Re-verified since Nov 1, 2011, no change to tracked fieldsv13-v14
  13. Primary completion date: Jul 2012
    • Study completion date: Dec 2012 to Dec 2013
    v12
  14. Study completion date: Dec 2011 to Dec 2012
    • Eligibility criteria revised
    • Study description expanded, about 10 words
    v11
  15. Study completion date: Dec 2010 to Dec 2011v10
  16. Re-verified, no change to tracked fieldsv9
  17. Study completion date: Dec 2009 to Dec 2010v8
  18. Study completion date: Jul 2009 to Dec 2009v7
  19. Re-verified, no change to tracked fieldsv6
  20. Study completion date: Jul 2008 to Jul 2009v5
  21. Enrollment target: 20 to 40v4
  22. 2 versions Re-verified since Aug 18, 2006, no change to tracked fieldsv2-v3
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00353197
Lead Sponsor Hadassah Medical Organization
Conditions
(from sponsor)		 Infertility
Related terms Infertility
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov