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Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

2014-08-27 03:15:03 | BioPortfolio

Summary

This study will evaluate the safety and efficacy of intravenous ex vivo cultured adult allogenic mesenchymal stem cells in patients with ischemic cerebral stroke. Patient will be given single intravenous dose of allogenic mesenchymal stem cells 2 million cells/Kg body weight or placebo within 10 days of stroke. Patients will be followed up till 12 months. Safety will be evaluated by type, number and proportion of patients with adverse events. Efficacy will be evaluated by clinical parameters and MRI.

Study Design

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

Conditions

Stroke

Intervention

Ex vivo cultured adult allogenic MSCs, Plasmalyte-A

Location

Hospital Kuala Lumpur
Jalan Pahang,
50586 Kuala Lumpur
Malaysia

Status

Not yet recruiting

Source

Stempeutics Research Pvt Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:03-0400

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Medical and Biotech [MESH] Definitions

Restoration of functions to the maximum degree possible in a person or persons suffering from a stroke.

Cells propagated in vitro in special media conducive to their growth. Cultured cells are used to study developmental, morphologic, metabolic, physiologic, and genetic processes, among others.

Stroke caused by lacunar infarction or other small vessel diseases of the brain. It features hemiparesis (see PARESIS), hemisensory, or hemisensory motor loss.

A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810)

A condition caused by the failure of body to dissipate heat in an excessively hot environment or during PHYSICAL EXERTION in a hot environment. Contrast to HEAT EXHAUSTION, the body temperature in heat stroke patient is dangerously high with red, hot skin accompanied by DELUSIONS; CONVULSIONS; or COMA. It can be a life-threatening emergency and is most common in infants and the elderly.

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