Pilot study of bone marrow-derived mesenchymal stem cells for the treatment of refractory hemorrhagic cystitis occurring after hematopoietic stem cell transplantatio
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0002826
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 3
1) Confirmed hemorrhagic cystitis patient occurring after allogeneic or autologous hematopoietic stem cell transplantation
2) Patients with ECOG performance status rating of 0, 1, or 2
3) Patients who are considered to be able to survive for 3 months or more
4) Patients without evidence of acute infectious disease
5) Patients who have no evidence of accompanying tumor
1) Pregnant, lactating women or women who have the possibiity of being pregnant or who have not taken adequate contraceptive
2) Patients with active infection or fever with unknown etiology or ongoing bacterial or fungal infection
3) ECOG performance status of 3 or 4
4) Patients with previously confirmed HIV infection, uncontrolled hypertension (diastolic blood pressure > 115mmg Hg), unstable angina, congestive heart failure (NY class II or higher), poorly controlled severe diabetes, coronary angioplasty within 6 months, Patients with acute myocardial infarction or non-malignant disease including uncontrolled atrial or ventricular arrhythmia within the last 6 months
5) Patients with mental illnesses,drug addiction, etc. who are judged to have an influence on the outcome of the study
6) Patients participating in other clinical trials (but, subject to the clinical judgment of the investigator)
7) Patients who are judged to be inadequate due to the judgment of the person in charge of clinical trial (principal investigator)
8) Patients with other serious medical conditions that may reduce compliance with clinical trials
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: physical examination, chest x-ray, EKG, blood chemistry, blood test, adverse event evaluation, ECOG performance evaluation, Assessment of quality of life
- Secondary Outcome Measures
Name Time Method Efficacacy: urine test, immunological analyses