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

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01235468
• Other study ID #: SHEBA-10-7959-AN-CTIL
• Status: Withdrawn
• Phase: Phase 1
• First received: November 2, 2010
• Last updated: December 1, 2015
• Start date: June 2012
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hematological Malignancies
• Stem Cell Transplantation
• Umbilical Cord Blood

Intervention

Biological:
• ex vivo expansion
ex-vivo expansion of cord blood for transplantation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Avichai Shimoni MD	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Number of patients with adverse events during infusion	1 month	Yes
Primary	engraftment	Time to engraftment	3 months	Yes
Primary	treatment-related toxicity	Type and severity of adverse events after transplantation using the NCI CTC scale	3 months	Yes
Primary	GVHD	Number of patients with acute and chronic GVHD after transplantation	1 year	Yes
Secondary	Immunological reconstruction	immunological reconstruction after transplantation measured by lymphocyte number and function	5 years	No
Secondary	relapse	rate of disease recurrence	5 years	No