Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell

A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell

Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.

Study Overview

• Status: Unknown
• Conditions: Graft-vs-Host Disease (GVHD)
• Intervention / Treatment: Procedure: Mesenchymal stem cell (MSC)

Detailed Description

This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10^6 MSC/Kg recipient´s bodyweight).

MSC will be infused, by a central venous catheter, to patients diagnosed with GVHD refractory to first-line or subsequent treatment.

All patients will receive the same treatment. MSC suspension will be obtained from the bone marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with autologous donor´s serum and with no animal-derived products.

• Study Type: Interventional
• Enrollment: 15
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Santa Creu i Sant Pau Hospital
    • Principal Investigator: David Varcárcel Ferrerías, MD
  • Barcelona, Spain, 08036
    • Recruiting
    • Clinic i Provincial Hospital
    • Principal Investigator: Carmen Martínez Muñoz, MD
  • Salamanca, Spain, 37007
    • Recruiting
    • University Hospital of Salamanca
    • Principal Investigator: Consuelo del Cañizo, MD
    • Principal Investigator: José A Pérez-Simón, MD
  • Pamplona
    • Navarra, Pamplona, Spain, 31080
      • Recruiting
      • University Clinic of Navarra
      • Principal Investigator: José Rifón Roca, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with hematological malignancies who had been undergone an allogenic hematopoietic stem cell transplant and diagnosed with GVHD refractory to a usual treatment.
• Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.
• Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
• Patients with ages between 18 and 65 years.
• Signature of informed consent form is required to be done by patient and donor.

Exclusion Criteria:

• Patients whose hematopathology has not been controlled by the transplant or is in progress.
• Patients with bacterial, viral or fungal infection not being controlled with the adequate treatment.
• Patients with an inadequate cardiac or pulmonary function.
• Patients who, in the investigator´s point of view, are not in situation to tolerate the treatment.
• Patients who do not have the required donor (HLA-identical sibling donor and not HLA-identical sibling donor).
• Pregnant females or childbearing potential who are not on adequate contraceptive measures.
• Patients <18 or >65 years.
• Patients who do not sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.
Efficacy will be evaluated in terms of GVHD response.
Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.

Secondary Outcome Measures

Outcome Measure
Evaluation of infectious complications after MSC infusion.
Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease.
Study the influence of MSC infusion on DFS and OS.
Determine MSC grafted into the bone marrow (or in other organs).

Collaborators and Investigators

• Sponsor: University of Salamanca
• Collaborators: Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
• Investigators: Study Chair: Consuelo del Cañizo, MD, Haematology Service, University Hospital of Salamanca; Principal Investigator: José A Pérez-Simón, MD, Haematology Service, University Hospital of Salamanca; Principal Investigator: David Varcárcel Ferrerías, MD, Haematology Service, Santa Creu i Sant Pau Hospital, Barcelona; Principal Investigator: Carmen Martínez Muñoz, MD, Haematology Service, Clinic i Provincial Hospital, Barcelona; Principal Investigator: José Rifón Roca, MD, Haematology Service, University Clinic of Navarra

Publications and helpful links

General Publications

• Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: March 13, 2007
• First Submitted That Met QC Criteria: March 13, 2007
• First Posted (Estimate): March 14, 2007

Study Record Updates

• Last Update Posted (Estimate): March 22, 2007
• Last Update Submitted That Met QC Criteria: March 20, 2007
• Last Verified: March 1, 2007

More Information

Terms related to this study

• Keywords: Refractory; Allotransplant; Allogenic; Graft-vs-host disease (GVHD); Mesenchymal stem cell (MSC); Allogeneic hematopoietic stem cell transplant; CSM/EICH2005
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: CSM/EICH2005; EudraCT Number: 2005-003674-14