Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning: a Pilot Study
Inclusion Criteria
V.1. Patients
V.1.1. Diseases
Hematological malignancies confirmed histologically and not rapidly progressing:
- AML in CR;
- ALL in CR;
- CML unresponsive/intolerant to Imatinib but not in blast crisis;
- Other myeloproliferative disorders not in blast crisis and not with extensive
myelofibrosis;
- MDS with < 5% blasts;
- Multiple myeloma;
- CLL;
- Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
- Hodgkin's disease.
V.1.2. Clinical situations
- Theoretical indication for a standard allo-transplant, but not feasible because:
- Age > 55 yrs;
- Unacceptable end organ performance;
- Patient's refusal.
- Indication for a standard auto-transplant: perform mini-allotransplantation 2-6
months after standard autotransplant.
V.1.3. Other inclusion criteria
- Male or female; fertile female patients must use a reliable contraception method;
- Age < 75 yrs.
- Informed consent given by patient or his/her guardian if of minor age.
V.1.4. Exclusion criteria
- Any condition not fulfilling inclusion criteria;
- HIV positive;
- Terminal organ failure, except for renal failure (dialysis acceptable);
- Uncontrolled infection, arrhythmia or hypertension;
- Previous radiation therapy precluding the use of 2 Gy TBI;
- HLA-identical donor.
V.2. PBSC donors
V.2.1. Inclusion criteria
- Related to the recipient (sibling, parent or child) or unrelated;
- Male or female;
- Weight > 15 Kg (because of leukapheresis);
- Fulfills generally accepted criteria for allogeneic PBSC donation;
- Informed consent given by donor or his/her guardian if of minor age, as per donor
center standard procedures.
V.2.2. Exclusion criteria
- Any condition not fulfilling inclusion criteria;
- HIV positive;
- Unable to undergo leukapheresis because of poor vein access or other reasons.
V.2.3. HLA matching
Related or unrelated donors who have 1-2 HLA mismatches, as either :
- One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
- One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1
- Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1
- One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1.
- One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C
or -DRB1
V.3. Cord blood unit
Banked cord blood units will be used if they fulfill the following criteria:
- No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic
mismatch at HLA-DRB1)
- > 2.5 x 107 TNC/kg
- Standard validation by FACT/Netcord criteria.