Topics

Effect of Different Transplantation Time for Mesenchymal Stem Cells(MSCs) of Cerebral Infarction Patients

2019-09-23 04:51:41 | BioPortfolio

Summary

This is a placebo controlled, randomized, double blinded study including Phase 1 and Phase 2. Phase I study is a safety assessment and Phase 2 study is incline to assess effectiveness of MSCs. Potential subjects must be screened and consented before enrolled.

The primary objective of this study is to determine the effects of different time points for intravenous infusion of allogeneic human umbilical cord mesenchymal stem cells (HucMSCs or MSCs used in the following section) for patients with acute ischemic stroke. Eligible patients will receive a single dose of MSCs or placebo within 12 hours or 5-7days after stroke. Patients will be followed for 2 years post infusion for safety and efficacy (change in neurological symptoms and quality of life). Assessments will occur during transplantation and at 3,7, 14 days and1,3, 6, 12, 18 and 24 months after infusions of stem cells.

Description

In Phase 1 study, the eligible patients with acute cerebral infarction 5-7 days after onset will be randomized to MSCs group or control group and receive intravenous MSCs 2 x 10^6/kg or placebo as a single dose, respectively. Each group will enroll 10 patients and patients will be followed for 2 years to observe the adverse events and evaluate the safety of MSCs for acute ischemic stroke patients.

The safety and preliminary effectiveness of MSCs in the treatment of acute cerebral infarction will be summarized after all patients of Phase 1 study were followed for 3 months post infusion, and the report will be submit to the academic committee and the ethics committee to evaluate before approval to begin the Phase 2 study.

In Phase 2 study, 100 patients with acute infarction within 12 hours after onset or 5-7 days after onset will be enrolled and randomized to MSCs group or control group. Patients will have baseline laboratory examinations and cerebral image (MRI or CTP). Enrolled patients will receive intravenous infusion of 2*10^6/kg MSCs or placebo for a single dose and follow for 24 months to assess the adverse events, neurological functional recovery and quality of life.

Study Design

Conditions

Infarction, Middle Cerebral Artery

Intervention

human umbilical cord mesenchymal stem cells, Placebo, standardized treatment

Location

Gang Li
Shanghai
Shanghai
China
200123

Status

Recruiting

Source

Shanghai East Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-23T04:51:41-0400

Clinical Trials [4594 Associated Clinical Trials listed on BioPortfolio]

Umbilical Cord Mesenchymal Stem Cells Therapy for Diabetic Nephropathy

This clinical trial assessed the safety of human umbilical cord mesenchymal stem cell therapy in 15 patients with diabetic nephropathy. Fifteen subjects received umbilical cord mesenchymal...

Study of Human Umbilical Cord-derived Mesenchymal Stem Cells for Treatment of Refractory Immune Thrombocytopenia

Primary Objective: To evaluate the safety and efficacy of human umbilical cord-derived mesenchymal stem cells(hUC-MSCs) to treat refractory immune thrombocytopenia(ITP). Secondary...

Evaluating Safety and Efficacy of Mesenchymal Stem Cells From Umbilical Cord

This study was to evaluate the safety and efficacy of Mesenchymal Stem Cells (MSCs) from umbilical cord in the treatment of 7 knee OA patients by assessing unexplained local and systemic s...

The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)

The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients

The Safety/Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Osteoarthritis

The purpose of this study is verify the efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) therapy for patients with Osteoarthritis, and in addition, provide basis...

PubMed Articles [26355 Associated PubMed Articles listed on BioPortfolio]

Proliferation and odontogenic differentiation of human umbilical cord mesenchymal stem cells and human dental pulp cells co-cultured in hydrogel.

The aim of this study was to evaluate the proliferation and odontogenic differentiation of human dental pulp cells (hDPCs) and human umbilical cord mesenchymal stem cells (hUCMSCs) in three-dimensiona...

Exosomal miR-451 from human umbilical cord mesenchymal stem cells attenuates burn-induced acute lung injury.

The aim of this study was to investigate the molecular mechanism of human umbilical cord mesenchymal stem cells (MSCs)-derived exosomes (hUCMSC-Exos) in regulating burn-induced acute lung injury (ALI)...

Nitrogen-doped carbon nanocages and human umbilical cord mesenchymal stem cells cooperatively inhibit neuroinflammation and protect against ischemic stroke.

This study aimed to explore the synergistic effects of nitrogen-doped carbon nanocages (NCNCs) and human umbilical cord mesenchymal stem cells (HUC-MSCs) on ischemic stroke and investigate the potenti...

Human umbilical cord mesenchymal stem cells pretreated with Angiotensin-II attenuate pancreas injury of rats with severe acute pancreatitis.

Mesenchymal stem cells (MSCs) pretreatment is an effective route for improving cell-based therapy of endothelial cell survival, vascular stabilization, and angiogenesis. We hypothesized that the appli...

Human umbilical cord mesenchymal stem cells derived-exosomes in diseases treatment.

Exosomes are extracellular vesicles with the size of 40-100 nm in diameter and a density of 1.13-1.19 g/mL, containing proteins, mRNAs, miRNAs, and DNAs. Exosomes change the recipient cells bioche...

Medical and Biotech [MESH] Definitions

Bone-marrow-derived, non-hematopoietic cells that support HEMATOPOETIC STEM CELLS. They have also been isolated from other organs and tissues such as UMBILICAL CORD BLOOD, umbilical vein subendothelium, and WHARTON JELLY. These cells are considered to be a source of multipotent stem cells because they include subpopulations of mesenchymal stem cells.

Transplantation of STEM CELLS collected from the fetal blood remaining in the UMBILICAL CORD and the PLACENTA after delivery. Included are the HEMATOPOIETIC STEM CELLS.

Endothelial cells that line venous vessels of the UMBILICAL CORD.

Jelly-like connective tissue of the UMBILICAL CORD that contains MESENCHYMAL STROMAL CELLS.

Venous vessels in the umbilical cord. They carry oxygenated, nutrient-rich blood from the mother to the FETUS via the PLACENTA. In humans, there is normally one umbilical vein.

More From BioPortfolio on "Effect of Different Transplantation Time for Mesenchymal Stem Cells(MSCs) of Cerebral Infarction Patients"

Quick Search

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Stem Cells
Track and monitor developments in stem cell research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on stem cells and follow companies active in the stem cell industry.  BioPort...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...


Searches Linking to this Trial