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

University of Salamanca

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Graft-vs-Host Disease (GVHD)

Treatments

Procedure: Mesenchymal stem cell (MSC)

Study type

Interventional

Funder types

Other

Identifiers

NCT00447460

CSM/EICH2005

EudraCT Number: 2005-003674-14

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.