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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yves Beguin, University Hospital of Liege
ClinicalTrials.gov Identifier:
NCT00504803
First received: July 19, 2007
Last updated: September 1, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Hematological Malignancies
Procedure: Mesenchymal stem cell infusion
Phase 2

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

Resource links provided by NLM:


Further study details as provided by University Hospital of Liege:

Primary Outcome Measures:
  • Day-100 incidence of non-relapse mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution [ Time Frame: 365 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: December 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MSC co-infusion with either HLA-mismatched PBSC or cord blood
Procedure: Mesenchymal stem cell infusion
Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.
Other Name: Mesenchymal stem cells

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504803

Locations
Belgium
CHU Sart Tilman
Liege, Belgium, 4000
Sponsors and Collaborators
University Hospital of Liege
Investigators
Principal Investigator: Frederic Baron, MD, PhD CHU-ULg
Principal Investigator: Yves Beguin, MD, PhD CHU-ULg
Study Chair: Chantal Lechanteur, PhD CHU-ULg
Study Chair: Etienne Baudoux, MD CHU-ULg
Study Chair: Evelyne Willems, MD CHU-ULg
  More Information

No publications provided by University Hospital of Liege

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yves Beguin, Prof, University Hospital of Liege
ClinicalTrials.gov Identifier: NCT00504803     History of Changes
Other Study ID Numbers: TJB0601
Study First Received: July 19, 2007
Last Updated: September 1, 2011
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by University Hospital of Liege:
HCT, nonmyeloablative, mesenchymal stem cells, GVHD

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on October 20, 2014