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

NCT00504803 | Completed Phase 2

• 1 other identifier: TJB0601
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hematological Malignancies

Keywords

HCT, nonmyeloablative, mesenchymal stem cells, GVHD

Outcome Measures

Primary Outcomes (1)

• Day-100 incidence of non-relapse mortality

  100 days

Secondary Outcomes (1)

• 1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution

  365 days

Study Arms (1)

1

EXPERIMENTAL

MSC co-infusion with either HLA-mismatched PBSC or cord blood

Procedure: Mesenchymal stem cell infusion

Interventions

Mesenchymal stem cell infusion PROCEDURE

Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.

Also known as: Mesenchymal stem cells

1

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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 :

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU Sart Tilman

Liège, Liege, 4000, Belgium

Location

Related Publications (1)

• Baron F, Lechanteur C, Willems E, Bruck F, Baudoux E, Seidel L, Vanbellinghen JF, Hafraoui K, Lejeune M, Gothot A, Fillet G, Beguin Y. Cotransplantation of mesenchymal stem cells might prevent death from graft-versus-host disease (GVHD) without abrogating graft-versus-tumor effects after HLA-mismatched allogeneic transplantation following nonmyeloablative conditioning. Biol Blood Marrow Transplant. 2010 Jun;16(6):838-47. doi: 10.1016/j.bbmt.2010.01.011. Epub 2010 Jan 28.

  PMID: 20109568 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Graft vs Host Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Frederic Baron, MD, PhD

  CHU-ULg

  PRINCIPAL INVESTIGATOR

• Yves Beguin, MD, PhD

  CHU-ULg

  PRINCIPAL INVESTIGATOR

• Chantal Lechanteur, PhD

  CHU-ULg

  STUDY CHAIR

• Etienne Baudoux, MD

  CHU-ULg

  STUDY CHAIR

• Evelyne Willems, MD

  CHU-ULg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: December 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 2, 2011

Record last verified: 2011-09

Locations

BE (1)