Advertisement

Topics

Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis

2014-08-27 03:38:27 | BioPortfolio

Summary

The standard treatment for decompensated cirrhosis is liver transplantation. But, it has several limitations. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. The investigators have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo controlled trial in 50 patients with decompensated cirrhosis.

Description

The standard treatment for decompensated cirrhosis is liver transplantation. But, it has several limitations including small donor pool, long waiting list, and several complications. Recent animal studies suggest that bone marrow stem cell transplantation can lead to regression of liver fibrosis. We have already completed the phase 1 study of bone marrow mesenchymal stem cell (MSC) transplantation in 4 patients with cirrhosis. The procedure was safe, and feasible, and led to somewhat promising results (Mohamadnejad M, et al. 2006; Submitted for publication). The aim of this study is to find efficacy of this new treatment strategy in the setting of a multicenter, randomized placebo controlled trial. After assignment of the written informed consent, fifty patients with decompensated cirrhosis will be enrolled, and will be randomized by block randomization into treatment or placebo arm. All the enrolled patients will be in the waiting list of liver transplantation. In the treatment arm bone marrow of the patients will be aspirated, and autologous bone marrow mesenchymal stem cells will be cultured, and then will be infused through a peripheral vein. Also, the corresponding placebo will be infused for the placebo group. The patients will be followed up for 1 year after performing the procedure.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Cirrhosis

Intervention

Autologous mesenchymal stem cell transplantation

Location

Digestive Disease Research Center, Shariati Hospital
Tehran
Iran, Islamic Republic of
14117-13135

Status

Recruiting

Source

University of Tehran

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:38:27-0400

Clinical Trials [2726 Associated Clinical Trials listed on BioPortfolio]

Mesenchymal Stem Cells Transplantation for Liver Cirrhosis Due to HCV Hepatitis

In this study, we aimed to transplant autologous, adipose tissue derived mesenchymal stem cells to the patients with liver cirrhosis due to HCV. We also aimed to assess liver tissue regene...

Bone Mesenchymal Stem Cell (BMSC) Transplantation in Liver Cirrhosis Via Portal Vein

The objective of this study is to evaluate the therapeutic efficacy of autologous bone marrow mesenchymal stem cells (BMSCs) transplantation via portal vein in patients with early and midd...

Autologous Mesenchymal Stem Cell (MSC) Transplantation in MS

The study is an investigator-run, open-label Phase 1 safety study of autologous mesenchymal stem cell transplantation, involving approximately 24 participants with relapsing forms of MS (a...

Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke

Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation pro...

Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control thei...

PubMed Articles [20580 Associated PubMed Articles listed on BioPortfolio]

Autologous Stem Cells Transplantation in Egyptian Patients with Liver Cirrhosis on Top of Hepatitis C Virus.

Use of pluripotent stem cells is an ideal solution for liver insufficiencies. This work aims is to evaluate the safety and feasibility of autologous stem cells transplantation (SCT) in Egyptian patien...

Lower Oncogenic Potential of Human Mesenchymal Stem Cells Derived from Cord Blood Compared to Induced Pluripotent Stem Cells.

In regenerative medicine, use of each of the mesenchymal stem cells derived from bone marrow, cord blood, and adipose tissue, has several cons and pros. Mesenchymal stem cells derived from cord blood ...

Persistent seropositivity for yellow fever in a previously vaccinated autologous hematopoietic stem cell transplantation recipient.

The duration of a protective level of yellow fever antibody after autologous hematopoietic stem cell transplantation in a previously vaccinated person has been unclear. Here, we describe a case who ha...

Case 8-2015: A Man with Multiple Myeloma, Skin Tightness, Arthralgias, and Edema.

To the Editor: Wigley et al. (March 12 issue)(1) discuss the case of a 68-year-old man with multiple myeloma and scleroderma. Notably, autologous stem-cell transplantation had been performed 7 months ...

Case 8-2015: A Man with Multiple Myeloma, Skin Tightness, Arthralgias, and Edema.

To the Editor: Wigley et al. (March 12 issue)(1) discuss the case of a 68-year-old man with multiple myeloma and scleroderma. Notably, autologous stem-cell transplantation had been performed 7 months ...

Medical and Biotech [MESH] Definitions

Transfer of MESENCHYMAL STEM CELLS between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS).

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

The transfer of STEM CELLS from one individual to another within the same species (TRANSPLANTATION, HOMOLOGOUS) or between species (XENOTRANSPLANTATION), or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). The source and location of the stem cells determines their potency or pluripotency to differentiate into various cell types.

The transference of BONE MARROW from one human or animal to another for a variety of purposes including HEMATOPOIETIC STEM CELL TRANSPLANTATION or MESENCHYMAL STEM CELL TRANSPLANTATION.

Transplantation of stem cells collected from the peripheral blood. It is a less invasive alternative to direct marrow harvesting of hematopoietic stem cells. Enrichment of stem cells in peripheral blood can be achieved by inducing mobilization of stem cells from the BONE MARROW.

More From BioPortfolio on "Mesenchymal Stem Cell Transplantation in Decompensated Cirrhosis"

Quick Search
Advertisement
 

Searches Linking to this Trial