Intrabone Infusion of Umbilical Cord Blood Stem Cells

Inclusion Criteria:

• One to 21 years of age;
• More than 10 kg in weight;
• Diagnosis of hematopoietic disorders (malignant or not) with an indication for hematopoietic stem cell transplantation;
• Absence of an HLA-identical related donor;
• Availability of a single cord blood (CB) with at least 3 x 10^7 nucleated cells (NCs)/kg (if HLA identical or 1 HLA-mismatch) or at least 4 x 10^7 NCs/kg (if a 2 HLA-mismatch) at freezing. Use of two CB units ("double cord transplant") will be allowed provided that: 1) a single CB unit fulfilling the above criteria is not available; 2) a maximum of 2 HLA mismatch is present for each CB unit; and 3) a minimum of 4 x 10^7 NCs/kg (as the sum for both CB units) is present at freezing.
• A myeloablative-conditioning regimen;
• A Lansky (for patients less than 16 years of age) or Karnofsky (for patients more than 16 years of age) score equal to or higher than 70%.
• Adequate organ function as follows:
• Cardiac (ejection fraction > 50%);
• Renal (serum creatinine within the normal range for age, and creatinine clearance or a GFR > 70 ml/min/1.73m2);
• Hepatic (AST or ALT < 5 x upper limit of normal for age);
• Pulmonary (FEV1, FVC, and DLCO ≥ 50% by pulmonary function tests or, in children unable to cooperate, no sign of dyspnea at rest, no exercise intolerance, no supplementary oxygen therapy, and a normal pulmonary radiography or pulmonary scan);
• No sign of uncontrolled systemic bacterial, fungal or viral infection;
• Written informed consent by the patient or his/her legal guardian

Exclusion Criteria:

• Non-myeloablative conditioning;
• Pregnancy or breastfeeding;
• HIV positive serology;
• Bone disease (e.g. osteopetrosis, osteogenesis imperfecta)
• Previous autologous or allogeneic hematopoietic stem cell transplantation performed up to one year before enrolment, except in the case of non-engraftment or early rejection of a previous allogeneic stem cell transplantation.
• Active skin infection at the site of intrabone injection.
• History of intolerance/allergy to sedation medications or local anesthetics.
• Contraindication to sedation