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
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:
Neoplasms
Graft vs Host Disease
Hematologic Neoplasms
Immune System Diseases
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on April 20, 2014