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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00353197
First received: July 16, 2006
Last updated: September 7, 2014
Last verified: September 2014
  Purpose

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.


Condition
Infertility

Study Type: Observational
Official Title: The Derivation of New Human Embryonic Stem Cell Lines for Clinical Use

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Biospecimen Retention:   Samples With DNA

Blood serum samples of donor couple.


Estimated Enrollment: 40
Study Start Date: July 2002
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Embryo donors who have derived embryos via IVF and have surplus embryos that they will not use for family-building.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353197

Contacts
Contact: Benjamin E. Reubinoff, M.D. PhD. 011-972-2-677-7111 ext 74569 reubinof@md.huji.ac.il
Contact: Nitzchiya Geva, B.S.N. 011-972-2-677-7111 ext 7174 NitshiaG@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    011-972-2-677-7111 ext 76095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    011-972-2-677-7111 ext 77572    lhadas@hadassah.org.il   
Principal Investigator: Benjamin E. Reubinoff, M.D. PhD.         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Benjamin E. Reubinoff, M.D. PhD. Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00353197     History of Changes
Other Study ID Numbers: 33-26.07.02-HMO-CTIL
Study First Received: July 16, 2006
Last Updated: September 7, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
IVF
embryos
research
donation
surplus
stem cells

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on November 27, 2014