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Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

NCT01091701 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2016-05-12

No results posted yet for this study

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

Interventions

BIOLOGICAL

Ex vivo cultured adult allogenic MSCs

Single IV dose of allogenic MSCs

OTHER

Plasmalyte-A

Single IV dose of Plasmalyte-A

Sponsors & Collaborators

  • Stempeutics Research Malaysia SDN BHD

    collaborator UNKNOWN

  • Stempeutics Research Pvt Ltd

    lead INDUSTRY

Principal Investigators

  • Dr Abdul Syukur Abdullah, MD · Hospital Sultanah Bahiyah Consultant Physician, Medical Department, Km 6 Jalan Langgar, 5460 Alor Setar, Kedah

  • Dr Irene Looi, MD · Hospital Seberang jaya Jalan Tun Hussein Onn 13700 Prai, Pulau Pinang

  • Dr Uduman Ali Mohamed Yousuf, MD · Hospital Melaka Consultant Neurologist, Neurology Clinic, Medical Department, Jalan Mufti Haji Khalil, 75400 Melaka

  • Dr Dato K Chandran, MD · Hospital Raja Permaisuri Bainun Consultant Physician, Jalan Hospital, 30990,Ipoh, Perak

  • Dr Chuah Siew Kee, MD · Hospital Sungai Buloh Consultant Physician, Department of Medicine, Jalan Hospital, 47000 Sungai Buloh, Selangor

  • Dr Yau Weng Keong, MD · Hospital Kuala Lumpur Consultant Physian and Geriatrician, Jalan Pahang, 50586 Kuala Lumpur

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Malaysia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01091701 on ClinicalTrials.gov