A phase I study to evaluate the safety of four repeated infusions of bone marrow-derived mesenchymal stem cells for the treatment of steroid-refractory and progressive chronic graft-versus host disease.
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 10
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Response rate and molecular mechanisms of MSC treatment through the monitoring of immunological markers