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Sponsored by: |
University Hospital of Liege |
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Information provided by: | University Hospital of Liege |
ClinicalTrials.gov Identifier: | NCT00504803 |
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 |
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Hematological Malignancies |
Procedure: Mesenchymal stem cell infusion |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 30 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | May 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MSC co-infusion with either HLA-mismatched PBSC or cord blood
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Procedure: Mesenchymal stem cell infusion
Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.
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Ages Eligible for Study: | up to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
V.1. Patients
V.1.1. Diseases
Hematological malignancies confirmed histologically and not rapidly progressing:
V.1.2. Clinical situations
Theoretical indication for a standard allo-transplant, but not feasible because:
V.1.3. Other inclusion criteria
V.1.4. Exclusion criteria
V.2. PBSC donors
V.2.1. Inclusion criteria
V.2.2. Exclusion criteria
V.2.3. HLA matching
Related or unrelated donors who have 1-2 HLA mismatches, as either :
V.3. Cord blood unit
Banked cord blood units will be used if they fulfill the following criteria:
Contact: Frederic Baron, MD, PhD | 32-4-366 72 01 | F.Baron@ulg.ac.be |
Contact: Yves Beguin, MD, PhD | 32-4-366 72 01 | yves.beguin@chu.ulg.ac.be |
Belgium | |
CHU Sart Tilman | Recruiting |
Liege, Belgium, 4000 | |
Principal Investigator: Frederic Baron, MD, PhD | |
Principal Investigator: Yves Beguin, MD, PhD | |
Sub-Investigator: Chantal Lechanteur, PhD | |
Sub-Investigator: Etienne Baudoux, MD | |
Sub-Investigator: Evelyne Willems, MD |
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 |
Responsible Party: | University Hospital of Liege ( Baron Frédéric ) |
Study ID Numbers: | TJB0601 |
Study First Received: | July 19, 2007 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00504803 History of Changes |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
HCT, nonmyeloablative, mesenchymal stem cells, GVHD |
Graft Versus Host Disease Hematologic Neoplasms Hematologic Diseases Graft vs Host Disease Homologous Wasting Disease |
Neoplasms Neoplasms by Site Immune System Diseases |
Hematologic Neoplasms Hematologic Diseases Graft vs Host Disease |