Safety and Efficacy of Diverse Mesenchymal Stem Cells Transplantation for Liver Failure

Liver Failure Clinical Trial

Official title:

Clinical Comparison of Safety and Efficacy of Allogeneic Umbilical-Cord and Bone Marrow-derived Mesenchymal Stem Cells Transplantation for HBV-related Liver Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01844063
• Other study ID #: The Third Affiliated Hospital
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 20, 2013
• Last updated: July 4, 2013
• Start date: July 2013
• Est. completion date: January 2019

Study information

• Verified date: July 2013
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Qihuan Xu, Doctor
• Phone: +86 20 85253179
• Email: xqh0303[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

HBV-related liver failure (HBV-LF), a dramatic clinical syndrome, is characterized with massive necrosis of liver cells. Liver transplantation might be the most effective therapy for HBV-LF. However, there are a lot of problems such as lack of donors, surgical complications, transplant rejection, and high cost, which could limit the application of liver transplantation. It is demonstrated that mesenchymal stem cells could directionally differentiate into hepatocytes and cholangiocytes in injured liver, as well as reduce inflammation of the liver by immune regulation. In this study, we assess the safety and efficacy of human bone marrow and umbilical cord mesenchymal stem cells transplantation for patients with HBV-LF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: January 2019
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Aged 18-65 years

• Liver failure

• Negative pregnancy test (female patients in fertile age)

• Written consent

• HBsAg positive

• TB=171 µmol/L or ascend =17.1 µmol/L/per day,

• INR=1.5 or 20%<PTA=40%

• 17=MELD score=30

Exclusion Criteria:

• Hepatocellular carcinoma or other malignancies

• Severe problems in other vital organs(e.g.the heart,renal or lungs)

• Pregnant or lactating women

• Severe bacteria infection

• Anticipated with difficulty of follow-up observation

• Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on

• Other candidates who are judged to be not applicable to this study by doctors

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Failure

Intervention

Genetic:
• Conventional plus BM-MSC treatment
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times).
• Conventional plus UC-MSC treatment
Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times)

Drug:
• Conventional treatment
Received conventional treatment including: A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma.

Locations

Country	Name	City	State
China	Qi Zhang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate	The survival rate and time	72 weeks	No
Secondary	Liver function	The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST),Cholinesterase (CHE) ,Total Bilirubin(TB),Direct Bilirubin(DB), Serum Albumin (ALB)	72 weeks after treatment	No
Secondary	Marker of liver cancer	The level of alpha-fetoprotein (AFP)	72 weeks after treatment	No
Secondary	The degree of hepatic necrosis	The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)	2 years after treatment	No
Secondary	The improvement of symptoms	The improvement of clinical symptoms [including appetite, debilitation, abdominal distension, edema of lower limbs, et al	72 weeks after treatment	No
Secondary	The score for Model for End-Stage Liver Disease		72 weeks after treatment	No
Secondary	The improvement of immune function	cluster of differentiation 4 (CD4+)T/ cluster of differentiation 8 (CD8+)T,T helper cell 1 (Th1)/ T helper cell 1(Th2),natural killer cell(NK),natural killer T(NK T),interleukin-1ß(IL-1ß),interleukin-4(IL-4),interleukin-6(IL-6),interleukin-8(IL-8),interleukin-12(IL-12),interleukin-15(IL-15),interleukin-17A(IL-17A),Tumor necrosis factor-alpha (TNF-a),Interferon-gamma (IFN-?)	72 weeks after treatment	No
Secondary	complications	The occurrence of complications [including body temperature, tetter and allergy]	Between 0 to 8 hours after MSC transfusion	Yes
Secondary	The incidence of hepatocellular carcinoma		72 weeks after treatment	Yes