NCT01091701

Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

A Randomized, Double Blind, Multicentric, Placebo Controlled, Single Dose, Phase -I/ II Study Assessing The Safety And Efficacy Of Intravenous Ex Vivo Cultured Adult Allogenic Mesenchymal Stem Cells In Patients With Ischemic Cerebral Stroke

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stempeutics Research Pvt Ltd · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
BIOLOGICAL	Ex vivo cultured adult allogenic MSCs	Single IV dose of allogenic MSCs
OTHER	Plasmalyte-A	Single IV dose of Plasmalyte-A

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-03-24
• Last updated: 2016-05-12

Locations

6 sites across 1 country: Malaysia