Treatment of Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell.

NCT01956903 | Completed Phase 1

• 2 other identifiers: CSM/EICH20102010-020947-11
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of sequential infusion of allogenic mesenchymal stem cells (MSC) expanded "in vitro" in treating patients with acute graft-versus-host disease refractory to first-line therapy.

Conditions

Chronic Graft-Versus-Host Disease

Keywords

mesenchymal stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Adverse effects

  * Infusion related. * Infection Rate.

  from infusion to 100 days after stem cell transplant

Secondary Outcomes (1)

• efficacy

  Acute Graft-Versus-Host Disease period (100 days)

Study Arms (1)

Allogenic Mesenchymal Stem Cell

EXPERIMENTAL

Sequential Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell (MSC). Dosage 0,7 x 10e6 MSC/Kg/dose (cumulative minimum dose: 2,8 x 10e6 CSM/Kg.

Genetic: Allogenic Mesenchymal Stem Cell

Interventions

Allogenic Mesenchymal Stem Cell GENETIC

Expanded in-Vitro Allogenic Mesenchymal Stem Cell (authorized by Spain, "Agencia Española de Medicamentos y Productos Sanitarios" with number 06-076)

Allogenic Mesenchymal Stem Cell

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hematologic malignancies who have undergone allogenic stem cell transplantation and who are diagnosed with acute graft-versus-host-disease refractory to first-line treatment.
• Patients must have adequate cardiac function without evidence of uncontrolled hypertension, congestive heart failure or myocardial infarction within 6 months prior to the process.
• Adequate pulmonary function with no evidence of severe obstructive or restrictive pulmonary disease.
• Be able to understand the information and sign the informed consent.

You may not qualify if:

• Patients with uncontrolled disease or in progress at the time of treatment.
• Patients with uncontrolled bacterial, viral or fungal infection.
• Patients with inadequate cardiac or pulmonary function.
• Patients who do not have the required donor.
• Women pregnant or at risk of pregnancy by inadequate contraceptive measures.
• Patients who in the opinion of the investigator are not able to participate in the study.

Sponsors & Collaborators

• Grupo Espanol de trasplantes hematopoyeticos y terapia celular: lead

Study Sites (1)

Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Madrid, Madrid, 28010, Spain

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Fermín M Sánchez Guijo, MD

  Hospital Universitario de Salamanca, Salamanca. Spain.

  PRINCIPAL INVESTIGATOR

• Felipe Prosper, MD

  Clínica Universitaria de Navarra, Spain.

  PRINCIPAL INVESTIGATOR

• Eduardo Olavarría, MD

  Hospital de Navarra, Spain

  PRINCIPAL INVESTIGATOR

• Rocío Parody, MD

  Hospital Universitario Virgen del Rocío, Seville, Spain.

  PRINCIPAL INVESTIGATOR

• Carmen Regidor, MD

  Hospital Universitario Puerta del Hierro, Spain

  PRINCIPAL INVESTIGATOR

• Carmen Martínez, MD

  Hospital Clinic i Provincial de Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Rodrigo Martino, MD

  Hospital de la Santa Creu i Sant Pau, Spain

  PRINCIPAL INVESTIGATOR

• José Antonio Pérez-Simón, MD

  Hospital Universitario Virgen del Rocío, Seville, Spain.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: January 1, 2010
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 8, 2013

Record last verified: 2013-09

Locations

ES (1)