NCT00447460

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 14, 2007

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

March 22, 2007

Status Verified

March 1, 2007

First QC Date

March 13, 2007

Last Update Submit

March 20, 2007

Conditions

Graft-vs-Host Disease (GVHD)

Keywords

Graft-vs-host disease (GVHD)Mesenchymal stem cell (MSC)Allogeneic hematopoietic stem cell transplantAllotransplantAllogenicRefractoryCSM/EICH2005

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • 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).

Interventions

Mesenchymal stem cell (MSC)PROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Santa Creu i Sant Pau Hospital

Barcelona, Barcelona, 08025, Spain

RECRUITING

Clinic i Provincial Hospital

Barcelona, Barcelona, 08036, Spain

RECRUITING

University Clinic of Navarra

Navarra, Pamplona, 31080, Spain

RECRUITING

University Hospital of Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 21393326DERIVED

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Consuelo del Cañizo, MD

    Haematology Service, University Hospital of Salamanca

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mercedes Comas, CRA

CONTACT

+(034)915545476mercedes.comas@logitest.es

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2007

First Posted

March 14, 2007

Study Start

January 1, 2007

Study Completion

August 1, 2009

Last Updated

March 22, 2007

Record last verified: 2007-03

Locations

ES(4)