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

Hematological Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504803
• Other study ID #: TJB0601
• Status: Completed
• Phase: Phase 2
• First received: July 19, 2007
• Last updated: September 1, 2011
• Start date: December 2006
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Graft vs Host Disease
• Hematological Malignancies

Intervention

Procedure:
• Mesenchymal stem cell infusion
Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.

Locations

Country	Name	City	State
Belgium	CHU Sart Tilman	Liege

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Day-100 incidence of non-relapse mortality		100 days	Yes
Secondary	1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution		365 days	Yes