Hematological Malignancies, Stem Cell Transplantation, Umbilical Cord Blood
Conditions
Keywords
umbilical cord blood, ex vivo expansion, engraftment, GVHD
Brief 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.
Detailed 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.
Interventions
BIOLOGICALex vivo expansion
ex-vivo expansion of cord blood for transplantation
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Dr. Avichai Shimoni MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 1 month | Number of patients with adverse events during infusion |
| engraftment | 3 months | Time to engraftment |
| treatment-related toxicity | 3 months | Type and severity of adverse events after transplantation using the NCI CTC scale |
| GVHD | 1 year | Number of patients with acute and chronic GVHD after transplantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunological reconstruction | 5 years | immunological reconstruction after transplantation measured by lymphocyte number and function |
| relapse | 5 years | rate of disease recurrence |
Outcome results
None listed