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Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders

Phase 1
18 Years
70 Years
Not Enrolling
Umbilical Cord Blood, Stem Cell Transplantation, Hematological Malignancies

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Trial Information

Allogenic Transplantation of Ex-vivo Expanded CB Progenitors for Haematological Disorders

Stem cell transplantation is a curative approach for patients with hematological
malignancies. Umbilical cord blood is a source of stem cells for transplantation in patients
with no related donor. However, in adults, the number of stem cells in a single unit, may be
too low to allow engraftment, and the time to engraftment may be prolonged, increasing the
risks of the transplant. In this study, we expand part of the cord blood unit, in the lab,
trying to increase unit size, such that it would be suitable for adults, and would allow
safe engraftment.

Inclusion Criteria:

- age > 18 years

- hematological malignancy

- standard indication for allogeneic transplantation

- expected survival time over 12 weeks

- no related or unrelated donor

- availability of a cord blood unit of compatible placental blood cryopreserved in at
least 2 different bags; one of the two units should have a cellular content at least
equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight

Exclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status >2

- Prior allogeneic transplantation

- Pregnant or nursing women

- Positive serology for hepatitis B or C

- HIV positive

- Left ventricular ejection fraction < 50%

- DLCO < 50%

- Psychiatric, addictive, or any disorder/disease which compromises ability to give
informed consent for participation in this study

- Treatment with other investigational drugs within 4 weeks of enrolling in this

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Number of patients with adverse events during infusion

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Arnon Nagler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chaim Sheba Medical Center


Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:




Start Date:

June 2012

Completion Date:

November 2015

Related Keywords:

  • Umbilical Cord Blood
  • Stem Cell Transplantation
  • Hematological Malignancies
  • umbilical cord blood
  • ex vivo expansion
  • engraftment
  • GVHD
  • Neoplasms
  • Hematologic Diseases
  • Hematologic Neoplasms