Dose Finding Study to Assess Safety and Efficacy of Stem Cells in Liver Cirrhosis
Summary
This study will evaluate the safety and efficacy of mesenchymal stem cells in patients with cirrhosis of liver. Stem cells will be injected into the hepatic artery. Improvement in various parameters will be observed over 2 years.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Alcoholic Liver Cirrhosis
Intervention
Standard protocol of care, Allogeneic Mesenchymal Stem Cells, Allogeneic Mesenchymal Stem Cells, Allogeneic Mesenchymal Stem Cells
Location
Centre for Liver Research & Diagnostics
Hyderabad
Andhra Pradesh
India
500058
Status
Recruiting
Source
Stempeutics Research Pvt Ltd
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01591200
- Information obtained from ClinicalTrials.gov on August 09, 2012
Medical and Biotech [MESH] Definitions
Mesenchymal Stem Cell Transplantation
Transfer of MESENCHYMAL STEM CELLS between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS).
Graft Rejection
An immune response with both cellular and humoral components, directed against an allogeneic transplant, whose tissue antigens are not compatible with those of the recipient.
Bloodless Medical And Surgical Procedures
The treatment of patients without the use of allogeneic BLOOD TRANSFUSIONS or blood products.
Mesenchymal Stem Cells
Cells that can develop into distinct mesenchymal tissue such as BONE; TENDONS; MUSCLES; ADIPOSE TISSUE; CARTILAGE; NERVE TISSUE; and BLOOD and BLOOD VESSELS.
Bone Marrow Purging
Techniques for the removal of subpopulations of cells (usually residual tumor cells) from the bone marrow ex vivo before it is infused. The purging is achieved by a variety of agents including pharmacologic agents, biophysical agents (laser photoirradiation or radioisotopes) and immunologic agents. Bone marrow purging is used in both autologous and allogeneic BONE MARROW TRANSPLANTATION.
Clinical Trials
Allogeneic Mesenchymal Stem Cells Transplantation for Systemic Sclerosis (SSc)
This study will explore safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) to treat patients with diagnosis of systemic sclerosis(SSc) who have been resistant...
Primary Objective The primary objective of this study is to evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the...
This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in subjects...
Allogeneic Hematopoietic Stem Cell Transplant for Epidermolysis Bullosa
This is an open-label, single institution, phase II study in patients with epidermolysis bullosa (EB). The underlying hypothesis is that the infusion of bone marrow or umbilical cord blood...
Unrelated Umbilical Cord Blood Transplantation With Coinfusion of Mesenchymal Stem Cells
A pilot study to assess the feasibility of unrelated umbilical cord blood transplantation with coinfusion of third-party mesenchymal stem cells after myeloablative or nonmyeloablative cond...
PubMed Articles
Immunological Aspects of Allogeneic Mesenchymal Stem Cell Therapies.
Allogeneic mesenchymal stem or stromal cells (MSC) are proposed as cell therapies for degenerative, inflammatory and autoimmune diseases. The feasibility of allogeneic MSC therapies rests heavily on t...
Although the majority of patients with Hodgkin lymphoma achieve sustained remission with frontline treatment, there is still a subset of patients with much less favorable prognosis. The current standa...
Intense research is under way to determine the optimal stem cell type and regimen for repairing diseased myocardium. Although initial studies in humans focused on the use of homologous stem cells, all...
CONTEXT Mesenchymal stem cells (MSCs) are under evaluation as a therapy for ischemic cardiomyopathy (ICM). Both autologous and allogeneic MSC therapies are possible; however, their safety and efficacy...
Allogeneic mesenchymal stem cells transplantation in patients with refractory RA.
This study aimed to determine the safety and efficacy of allogeneic mesenchymal stem cells transplantation (MSCT) in refractory rheumatoid arthritis (RA). Four patients with persistently active RA und...
