Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease

University of Liege

Status and phase

Completed

Phase 2

Conditions

Hematological Malignancies

Treatments

Procedure: Mesenchymal stem cell infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00504803

TJB0601

Details and patient eligibility

About

Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study

Enrollment

30 estimated patients

Sex

All

Ages

Under 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.