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

NCT00353197 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2025-03-05

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Benjamin E. Reubinoff, M.D. PhD. · Hadassah Medical Organization

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-07-07
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00353197 on ClinicalTrials.gov