Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis

Liver Cirrhosis Clinical Trial

— LC  

Official title:

Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01573923
• Other study ID #: Alliancells-2012-1
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: April 6, 2012
• Last updated: April 12, 2015
• Start date: July 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2012
• Source: Alliancells Bioscience Corporation Limited
• Contact: Xuetao Pei, MD,PhD
• Phone: 86-10-68214650
• Email: peixt[@]nic.bmi.ac.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. In this current prospective cohort, the investigators plan to organize four hospitals to determine the safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the treatment of patients with liver cirrhosis in next three years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: October 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• written informed consent

• aged 30-60 years

• clinical diagnosis of compensated or decompensated liver

• child-Pugh B/C (7-12 points)

• expecting lifetime is over three years

Exclusion Criteria:

• pregnant woman

• patient with severe vascular diseases

• patient with any organ failure

• patient with any tumors

• patient with HIV

• patient who has been transplanted

• patient treated with immunosuppressors

• patient for whom the follow-up is considered impossible

• patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Study Design

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

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Biological:
• mesenchymal stem cells
Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
• Conventional therapy
Conventional therapy without cell therapy

Locations

Country	Name	City	State
China	The 302 Hospital of Chinese People's Liberation Army	Beijing	Beijing
China	the First Affiliated Hospital of Lanzhou University	Lanzhou	Gansu
China	The first people's hospital of Lianyungang	Lianyungang	Jiangsu
China	Hainan BOAO Life infinity international anti-aging medical center	Qionghai	Hainan
China	Tongji Hospital of Tongji University	Shanghai	Shanghai
China	The 323 Hospital of Chinese People's Liberation Army	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Alliancells Bioscience Corporation Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival time		3-year follow up	Yes
Secondary	Serum markers regarding liver and kidney function	liver functions:Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function:Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)	0, 3, 6, 9 and 12 months	Yes
Secondary	Serum markers regarding lipid and sugar profile	Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar;	0, 3, 6, 9 and 12 months	Yes
Secondary	Serum markers regarding cytokine profile	IL-1ß, IL-4, IL-6, IL-8, IL-10, IL-12(p40), IL-15, IL-17A, TNFa, TNFß, IFN-?, RANTES, TGFß, lymphotactin, and C-reactive protein level (CRP)	0, 3, 6, 9 and 12 months	Yes
Secondary	Serum levels of Hepatitis B and C	Serum levels of Hepatitis B and C	0, 3, 6, 9 and 12 months	Yes
Secondary	tolerance and the adverse events	The classification for uncomfortable reaction is: 0, no discomfort; 1, slightly unwell, does not affect daily life; 2, moderate discomfort, affects daily life and work; 3, moderately unwell, significantly affects life, and bed rest; 4, severely unwell, life-threatening.; A serious adverse event is defined as fatal, life threatening, permanently disabling, and tumors, particularly hepatocellular carcinoma.	3-year follow up	Yes
Secondary	Changes of any clinical symptoms	abdominal distension, appetite, debilitation, and edema of lower limbs.	3-year follow up	Yes