None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Product name: Allogeneic bone marrow derived mesenchymal stem cells
Cell dose: 1x10e6 cells / kg (body weight)
Number of doses: Total of 4 doses, every 2 weeks
Administ
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Minimum age of 1 year old up to maximum age of 80 years old * For pediatric patients aged 1 to 4 years old, informed consent must be attained from a legal guardian * For pediatric and adolescent patients aged from 5 to 12 years old must, assent (child's affirmative agreement) must be attained). * For patients over 13 up to 80 years old, informed consent must be attained from the patient himself. 2) Patients who have been diagnosed with chronic graft-versus-host disease following allogeneic hematopoietic stem cell transplantation and ? Who do not show clinical improvement following 4 weeks of conventional treatment including steroids and immunosuppresant (eg. FK506, cyclosporine) OR ? Who show worsening of clinical symptoms during 2 weeks of conventional therapy or during tapering process of immunosuppresants. 3) Eastern Cooperative Oncology Group (ECOG) performance rating of 0, 1, 2 4) Patients who are judged to survive for more than 3 months 5) Patients with no evidence of an acute infectious disease 6) Patients with no evidence of associated tumor 7) Patients who have voluntarily signed informed consent
Exclusion criteria
Exclusion criteria: 1) Pregnant women, nursing mothers or women who have the possibility of being pregnant or who did not take appropriate contraceptive measures. 2) Patients with unknown active infection or fever (=38 ?) or patients with bacterial or fungal infection 3) Patients aged less than 1 year old or more than 80 years old 4) Eastern Cooperative Oncology Group (ECOG) performance rating of 3, 4 5) Patients who have previously diagnosed with HIV infection, uncontrolled hypertension (diastolic blood pressure> 115 mmHg), unstable angina, congestive heart failure (that is not well controlled; New York Heart Association Functional classification class II or higher), severe diabetes, cornonary angioplasty within six months, any non-malignant diseases within the last six months including acute myocardial infarction, atrial or ventricular arrythmias. 6) Patients with mental disorders or drug addiction that are determined to affect the outcome of the study 7) Patients participating in another clinical trial (However, clinical judgment can be made by investigators) 8) Patients who are judged to be unfit for the clinical trial by clinical investigators 9) Patients with any other serious medical conditions that may decrease the adherence of the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of four repetitive infusions of mesenchymal stem cells(MSC) in steroid-refractory or progressive chronic graft-versus host disease patients following allogeneic hematopoietic stem cell transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate and molecular mechanisms of MSC treatment through the monitoring of immunological markers | — |
Countries
Korea, Republic of
Contacts
Public ContactNayoun Kim
The Catholic University of Korea
Outcome results
None listed