Status:
UNKNOWN
Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
Lead Sponsor:
University of Salamanca
Collaborating Sponsors:
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Conditions:
Graft-vs-Host Disease (GVHD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 al...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
End Date :
August 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00447460
Start Date
January 1 2007
End Date
August 1 2009
Last Update
March 22 2007
Active Locations (4)
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1
Santa Creu i Sant Pau Hospital
Barcelona, Barcelona, Spain, 08025
2
Clinic i Provincial Hospital
Barcelona, Barcelona, Spain, 08036
3
University Clinic of Navarra
Navarra, Pamplona, Spain, 31080
4
University Hospital of Salamanca
Salamanca, Salamanca, Spain, 37007