Phase IIb Clinical trial to Evaluate the Efficacy and Safety of Mesenchymal Stem Cell in Patients with Chronic Graft Versus Host Disease
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0003656
- Lead Sponsor
- SCM Lifescience
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 74
1) Male and female =19 years of age with body weight in the range of 40 ~ 80 kg
2) Patients diagnosed of chronic Graft Versus Host Disease(cGVHD) following allogeneic hematopoietic stem cell transplantation who are refractory to or dependent on standard steroid therapy
- No improvement despite treatment with prednisone or equivalent corticosteroid at= 1.0 mg/kg/day for 2 weeks;
- No improvement despite treatment with prednisone or equivalent corticosteroid at =0.5 mg/kg/day or 1.0 mg/kg/day every other day for 4 weeks; or
- Inability to taper prednisone or equivalent corticosteroid to >0.25 mg/kg/day or>0.5 mg/kg/day every other day without recurrence on at least 2 occasions separated by at least 8 weeks
3) Patients who received no more than 3 previous systemic GVHD therapies including steroids prior to Visit 1 (screening), and received stable dose for 2 weeks prior to Visit 2(baseline)
4) Patients who meet following criteria:
- Absolute neutrophil count (ANC) = 1,000 cells/mm3
- Serum creatinine < 2 x upper limit of normal (ULN)
5) Patients who meet any of the following conditions:
a. Patients who are surgically sterile
b. Post-menopausal female patients =45 years of age and >2 years after the last menstrual period
c. Pre-menopausal female patients of childbearing potential who agreed to using at least two contraceptive methods (including barrier method) at least up to 30 days
- after the last dose of investigational product to prevent pregnancy
d. Male patients who agreed to using recommended proper contraceptive methods
6) Patients who or whose representative received explanation about study details including objective and method and voluntarily signed the written consent form
1) Patient with acute GVHD (aGVHD) including Classic, de Novo Late, Recurrent Late, Persistent Late aGVHD
2) Patients with positive result in HIV antibody test
3) Patients with active result in Hepatitis B Virus(HBV) antigen or Hepatitis C Virus(HCV) antibody test
4) Patients with uncontrolled comorbidity such as moderate to severe infection or bleeding
5) Patients with severe (NYHA class III/IV) heart failure, congestive heart failure, or arrhythmias requiring treatment
6) Patients who received allogeneic hematopoietic stem cell transplantation more than once
7) Patients with positive reaction in penicillin skin test
8) Patients with relapse of underlying disease that primarily required hematopoietic stem cell transplantation (e.g., Acute Lymphocytic Leukemia(ALL), Chronic Myelogenous Leukemia(CML), Chronic Lymphocytic Leukemia(CLL), Acute Myeloid Leukemia(AML), Non-Hodgkin Lymphoma(NHL), and multiple myeloma) or patients diagnosed as secondary malignant disease after hematopoietic stem cell transplantation
9) Patients who received anti-thymocyte globulin (ATG) within 2 weeks prior to Visit 1(screening)
10) Patients with Forced Vital Capacity(FVC) or Forced Expiratory Volume in one second(FEV1) <40% (however, patients are allowed to participate in the study at the discretion of the investigator if there is no sign of active infection or if impaired pulmonary function is attributed to cGVHD)
11) Patients with history of pulmonary embolism or deep venous thrombosis within 24 hours prior to Visit 1 (screening)
12) Female patients who are pregnant or breast-feeding
13) Patients who participated in another study within 4 weeks prior to Visit 1 (screening)
14) Patients with unstable vital signs
15) Patients who are ineligible as judged by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall response rate
- Secondary Outcome Measures
Name Time Method overall response rate(every 2 weeks until 8 weeks, every 4 weeks until 24 weeks, every 24 weeks until 48 weeks)