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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Umbilical Cord Blood, Stem Cell Transplantation, Hematological Malignancies

Intervention / Treatment
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* Biological: ex vivo expansion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CB expnasion<br>ex-vivo expansion of cord blood for transplantation | Biological: ex vivo expansion<br>* ex-vivo expansion of cord blood for transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Number of patients with adverse events during infusion | 1 month | 
| engraftment | Time to engraftment | 3 months | 
| treatment-related toxicity | Type and severity of adverse events after transplantation using the NCI CTC scale | 3 months | 
| GVHD | Number of patients with acute and chronic GVHD after transplantation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological reconstruction | immunological reconstruction after transplantation measured by lymphocyte number and function | 5 years | 
| relapse | rate of disease recurrence | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical cord blood, ex vivo expansion, engraftment, GVHD