Allogenic Transplantation of Ex-vivo Expanded Cord Blood (CB)

Dr. Avichai Shimoni MD

Status and phase: Withdrawn; Phase 1

Conditions: Stem Cell Transplantation; Hematological Malignancies; Umbilical Cord Blood

Treatments: Biological: ex vivo expansion

Study type: Interventional

Funder types: Other

Identifiers

NCT01235468

SHEBA-10-7959-AN-CTIL

Details and patient eligibility

About

The aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.

Full description

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 protocol

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

CB expnasion

Experimental group

Description:

ex-vivo expansion of cord blood for transplantation

Treatment:

Biological: ex vivo expansion