Umbilical Cord Mesenchymal Stem Cells for Patients With Autoimmune Hepatitis
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|ClinicalTrials.gov Identifier: NCT01661842|
Recruitment Status : Unknown
Verified May 2013 by Fu-Sheng Wang, Beijing 302 Hospital.
Recruitment status was: Recruiting
First Posted : August 10, 2012
Last Update Posted : May 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Hepatitis||Other: conventional plus UC-MSC treatment Other: Conventional plus placebo treatment||Phase 1 Phase 2|
Autoimmune hepatitis (AIH) is an immune-mediated necroinflammatory disease of the liver characterized by elevation of IgG, presence of characteristic autoantibodies, and histological feature of interface hepatitis. Standard therapy consists of a combination of corticosteroids and azathioprine, which is efficacious in 80% of patients. However, current treatment strategies are complicated by frequent relapse after drug withdrawal, medication intolerance, and refractory disease. Alternative medical therapy may be need for AIH.
The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, bone marrow-derived mesenchymal stem cell (BM-MSC) transplantation has been applicated in the clinic for treat several human disease such as GVHD, cardiac injury and brain injury, and displayed good tolerance and efficiency. Recently, umbilical cord-derived MSCs (UC-MSC) has also been used to treat severe autoimmune diseases, such as immune thrombocytopenia, systemic lupus erythematosus, and therapy-resistant rheumatoid arthritis.
The purpose of this study is to learn whether and how UC-MSC can improve the disease condition in patients with autoimmune hepatitis (AIH). This study will also look at how well UC-MSC is tolerated and its safety in AIH patients
Participants in the study will be randomly assigned to one of two treatment arms:
Arm A: Participants will receive 12 weeks of UC-MSC treatment plus conventional treatment (combination of corticosteroids and azathioprine) Arm B: Participants will receive 12 weeks of placebo plus conventional treatment. (combination of corticosteroids and azathioprine) UC-MSC will be prepared according to standard procedures and is collected in plastic bags containing anticoagulant. UC-MSCs are given via i.v. under sonography monitoring. After cell therapy, patients are followed up at week 12, 24, 36, 48, 72, 96. The evaluation of some clinical parameters such as the level of serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), γ-globulin, total bilirubin (TB), prothrombin time (PT), albumin (ALB), prealbumin (PA) and IgG, are detected at these time points. MELD score, Liver histology, treatment side effects, relapse rate and clinical symptoms were also observed simultaneously.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Study of UC-MSC Treatment for Evaluation the Efficacy and Safety in Patients With Autoimmune Liver Disease|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2014|
Experimental: Conventional plus UC-MSC treatment
Participants will receive conventional treatment plus a dose of UC-MSC from day 0 through the week 12 study visit.
Participants will then be followed until the week 96 study visit.
Other: conventional plus UC-MSC treatment
Received conventional treatment and taken i.v., once per 4 week, at a dose of 1×106 UC-MSC/kg body weight for 12 weeks.
Experimental: Conventional plus placebo treatment
Participants will receive conventional plus placebo treatment from day 0 through the week 12 study visit. Participants will then be followed until the week 96 study visit.
Other: Conventional plus placebo treatment
Received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks
- Liver Histology change [ Time Frame: baseline and 96 weeks ]
- Serum alanine aminotransferase (ALT) [ Time Frame: 0,12, 24, 36, 48, 72, 96 weeks after treatment ]
- Serum AST [ Time Frame: At baseline and at week 12, 24, 36, 48, 72, 96 ]
- Serum Tbil [ Time Frame: At baseline and at week 12, 24, 36, 48, 72, 96 ]
- Serum immunoglobulin G (IgG) [ Time Frame: At baseline and at week 12, 24, 36, 48, 72, 96 ]
- Serum γ-globulin [ Time Frame: At baseline and at week 12, 24, 36, 48, 72, 96 ]
- MELD score [ Time Frame: At base line and at week 12, 24, 36, 48, 72, 96 ]
- Number of participants with treatment side effects [ Time Frame: At base line and at week 12, 24, 36, 48, 72, 96 ]weight gain, acne, facial rounding, dorsal hump formation, hirsutism, osteopenia and diabetes mellitus, et al
- Number of participants with improvement of clinical symptoms [ Time Frame: At base line and at week 12, 24, 36, 48, 72, 96 ]diffuse arthralgias, fatigue, generalized malaise, jaundice, abdominal pain, nausea, and loss of appetite
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661842
|Contact: Fu-Sheng Wang, professor||86-10-63879735 ext email@example.com|
|Contact: Zheng Zhang, Doctor||86-10-63879735 ext 2015.12||Zhangzheng1975@yahoo.com.cn|
|Beijing 302 Hospital||Recruiting|
|Beijing, Beijing, China, 100039|
|Contact: Fu-Sheng Wang, professor 86-10-63879735 ext 2015.12 firstname.lastname@example.org|
|Contact: Lifeng Wang, Doctor 86-10-63879735 ext 2015.12 email@example.com|
|Principal Investigator: Fu-Sheng Wang, Professor|
|Principal Investigator:||Fu-Sheng Wang, professor||Beijing 302 Hospital|