Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies

Ospedale Santa Croce-Carle Cuneo

Status and phase

Unknown

Phase 2

Phase 1

Conditions

High Risk Haematological Malignancies

Advanced Haematological Malignancies

Treatments

Procedure: Intrabone Allogeneic Transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT01613066

Emato68

Details and patient eligibility

About

Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies

Enrollment

15 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Advanced or High Risk Haematological Malignancies
Age 18-65 years
no suitable unrelated HLA-matched donors identified in a clinically useful time-frame
Informed consent

Exclusion criteria

Active infectious disease at inclusion
HIV- positivity or active hepatitis infection
Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit) at inclusion
Impaired renal function (Creatinine-clearance <60 ml/min; Serum Creatinine >1.5 x upper normal limit) at inclusion
Psychiatric diseases or conditions that might impair the ability to give informed consent