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

Primary Purpose

Graft-vs-Host Disease (GVHD)

Status

Unknown status

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Mesenchymal stem cell (MSC)

About this trial

This is an interventional treatment trial for Graft-vs-Host Disease (GVHD) focused on measuring Graft-vs-host disease (GVHD), Mesenchymal stem cell (MSC), Allogeneic hematopoietic stem cell transplant, Allotransplant, Allogenic, Refractory, CSM/EICH2005

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Clinic of NavarraRecruiting
Santa Creu i Sant Pau HospitalRecruiting
Clinic i Provincial HospitalRecruiting
University Hospital of SalamancaRecruiting

Outcomes

Primary Outcome Measures

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

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).

Full Information

NCT ID

NCT00447460

First Posted

March 13, 2007

Last Updated

March 20, 2007

Sponsor

University of Salamanca

Collaborators

Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán

1. Study Identification

Unique Protocol Identification Number

NCT00447460

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University of Salamanca

Collaborators

Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Graft-vs-Host Disease (GVHD)

Keywords

Graft-vs-host disease (GVHD), Mesenchymal stem cell (MSC), Allogeneic hematopoietic stem cell transplant, Allotransplant, Allogenic, Refractory, CSM/EICH2005

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Mesenchymal stem cell (MSC)

Primary Outcome Measure Information:

Title

Efficacy will be evaluated in terms of GVHD response.

Title

Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.

Secondary Outcome Measure Information:

Title

Evaluation of infectious complications after MSC infusion.

Title

Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease.

Title

Study the influence of MSC infusion on DFS and OS.

Title

Determine MSC grafted into the bone marrow (or in other organs).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mercedes Comas, CRA

Phone

+(034)915545476

Ext

mercedes.comas@logitest.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Consuelo del Cañizo, MD

Organizational Affiliation

Haematology Service, University Hospital of Salamanca

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

José A Pérez-Simón, MD

Organizational Affiliation

Haematology Service, University Hospital of Salamanca

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Varcárcel Ferrerías, MD

Organizational Affiliation

Haematology Service, Santa Creu i Sant Pau Hospital, Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carmen Martínez Muñoz, MD

Organizational Affiliation

Haematology Service, Clinic i Provincial Hospital, Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

José Rifón Roca, MD

Organizational Affiliation

Haematology Service, University Clinic of Navarra

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Clinic of Navarra

City

Navarra

State/Province

Pamplona

ZIP/Postal Code

31080

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

José Rifón Roca, MD

Facility Name

Santa Creu i Sant Pau Hospital

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Varcárcel Ferrerías, MD

Facility Name

Clinic i Provincial Hospital

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carmen Martínez Muñoz, MD

Facility Name

University Hospital of Salamanca

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Consuelo del Cañizo, MD

First Name & Middle Initial & Last Name & Degree

José A Pérez-Simón, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

21393326

Citation

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.

Results Reference

derived

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

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