Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage liver diseases. However, the critical shortage of donor organs, high cost, and the problem of immune rejection limit its clinical application, and even some patients on the waiting list will never survive to receive a matched liver. Stem cell transplantation instead of conventional medical therapy or orthotopic liver transplantation will be a promising alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs) are generally thought of as an autologous source of regenerative cells in previous studies.In this study, the safety and efficacy of menstrual blood-derived stem cells transplantation for patients with liver cirrhosis will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cirrhosis Fibrosis Liver Disease Digestive System Disease |
Biological: conventional therapy plus MenSC transplantation Drug: Conventional therapy plus placebo treatment |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1/2 Study of Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation for the Evaluation of the Efficacy and Safety in Patients With Liver Cirrhosis |
- Overall Survival [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Liver function improvement [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Complications [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al.
- The improvement of ascites after 12-week treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Child-Pugh score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- MELD score [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- SF36-quality of life [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention
Conventional therapy plus MenSCs treatment
|
Biological: conventional therapy plus MenSC transplantation
patients will receive conventional treatment,such as antiviral drugs, lowering aminotransferase and jaundice medicine. MenSCs transplantation: taken i.v., twice per week, at a dose of 1*10E6 MSC/kg body for 2 weeks. Other Names:
|
|
Active Comparator: No intervention
Conventional therapy plus placebo treatment: Oral or intravenous administration |
Drug: Conventional therapy plus placebo treatment
25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
Other Names:
|
Detailed Description:
The purpose of this study is to show whether menstrual blood-derived stem cells can improve the disease conditions in patients with liver cirrhosis.
One of two treatment arms will be assigned to the patients. One group will receive 2 weeks of conventional therapy plus MenSCs treatment; The other group will receive 2 weeks of conventional therapy plus placebo treatment.
MenSCs will be cultured and collected in a GMP lab. Patients were strictly monitored after the cells injection via i.v.. Patients are followed up at intervals up to at least 2 years.Clinical parameters such as ascites volume,serum alanine aminotransferase,total bilirubin,prothrombin time,albumin,MELD score,and Child-Pugh score will be evaluated at each timepoint.
Eligibility| Ages Eligible for Study: | 20 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Written informed consent
- Aged 20 to 50years
- Liver cirrhosis
- Negative pregnancy test
Exclusion Criteria:
- Pregnant or lactating women
- Malignancies
- Sepsis
- Vital organs failure
- Severe bacteria infection
- Vascular thromboses in the portal or hepatic veins
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01483248
| China, Zhejiang | |
| the First Affiliated Hospital of Zhejiang University-IRB | |
| Hangzhou, Zhejiang, China, 310003 | |
| Principal Investigator: | Charlie Xiang, Professor | S-Evans Biosciences Co.,Ltd. |
More Information
Additional Information:
Publications:
| Responsible Party: | S-Evans Biosciences Co.,Ltd. |
| ClinicalTrials.gov Identifier: | NCT01483248 History of Changes |
| Other Study ID Numbers: | SEB-1115-LC |
| Study First Received: | November 23, 2011 |
| Last Updated: | June 6, 2012 |
| Health Authority: | United States: Food and Drug Administration China: Food and Drug Administration |
Keywords provided by S-Evans Biosciences Co.,Ltd.:
|
Menstrual blood Mesenchymal stem cell Liver cirrhosis |
Additional relevant MeSH terms:
|
Digestive System Diseases Gastrointestinal Diseases Liver Cirrhosis Liver Diseases Interferons Ursodeoxycholic Acid Anti-Infective Agents |
Antineoplastic Agents Antiviral Agents Cholagogues and Choleretics Gastrointestinal Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015