Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

NCT ID: NCT01091701

Last Updated: 2016-05-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ex vivo cultured adult allogenic MSCs

Group Type: EXPERIMENTAL

Ex vivo cultured adult allogenic MSCs

Intervention Type: BIOLOGICAL

Single IV dose of allogenic MSCs

Plasmalyte-A

Group Type: PLACEBO_COMPARATOR

Plasmalyte-A

Intervention Type: OTHER

Single IV dose of Plasmalyte-A

Interventions

Ex vivo cultured adult allogenic MSCs

Single IV dose of allogenic MSCs

Intervention Type: BIOLOGICAL

Plasmalyte-A

Single IV dose of Plasmalyte-A

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 20 and 80 years old
• MRS equal to or less than 4.
• Full functional independence before present stroke.
• Patients will be included within the time frame of 10 days after an acute cerebral ischemic episode. This time period refers to the date of dosing.
• Neuro-imaging examination showing ischemic cerebral infarct.
• CT or MRI brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
• Stroke symptoms are to be present for at least 30 minutes and have not improved before treatment. Symptoms must be distinguishable from an episode of generalized ischemia (i.e. syncope), seizure, or migraine disorder. Patients should have motor weakness following the acute cerebral ischemic episode.
• Able to comply with study procedures for the entire length of the study

Exclusion Criteria

• Haematological causes of stroke
• Evidence of intracranial haemorrhage (ICH) on the CT-scan.
• Severe stroke as assessed clinically (e.g. MRS>4).
• Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition
• Previous intra-cranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arterial venous malformation, intra cranial surgery or radiological evidence of previous cerebral stroke with clinical manifestation.
• History of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
• Size and location of the cerebral infarct cannot be determined.
• Comatose / clinically unstable
• Serious, pre-existing medical conditions such as bleeding disorders (eg. leukopenia, thrombocytopenia) septicemia, TB, hepatic dysfunction (> 2.5 times the ULN of hepatic function tests) and renal dysfunction (Serum creatinine > 2 mg/dl).
• Disease or impairment that precludes adequate neurological exam
• Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is < 3.0 or > 20.0mmol/L.
• The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breast feeding.
• Patient is likely to be unavailable for follow-up e.g. no fixed home address
• Patients with evidence of life threatening infection or life threatening illness (e.g. advanced cancer) or having tested positive for HIV, Hepatitis B, Hepatitis C and VDRL
• Patient was already dependent in activities of daily living before the present acute stroke
• Patients who have been included in any other clinical trial within the previous month
• History of neoplasia or other comorbidity that could impact patient's short-term survival
• Previous or concomitant treatment with immune modulators or experimental drugs 60 days prior to study enrolment
• Any condition that in the judgment of the investigator would place the patient under undue risk
• Sustained systolic BP >220 mmHg, or <80mmHg, or diastolic BP > 140mmHg or <50 mmHg.
• Patients contraindicated for MRI examination.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stempeutics Research Malaysia SDN BHD

UNKNOWN

Sponsor Role: collaborator

Stempeutics Research Pvt Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Stempeutics Research Malaysia SDN BHD

Principal Investigators

Dr Abdul Syukur Abdullah, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sultanah Bahiyah Consultant Physician, Medical Department, Km 6 Jalan Langgar, 5460 Alor Setar, Kedah

Dr Irene Looi, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Seberang jaya Jalan Tun Hussein Onn 13700 Prai, Pulau Pinang

Dr Uduman Ali Mohamed Yousuf, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Melaka Consultant Neurologist, Neurology Clinic, Medical Department, Jalan Mufti Haji Khalil, 75400 Melaka

Dr Dato K Chandran, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Raja Permaisuri Bainun Consultant Physician, Jalan Hospital, 30990,Ipoh, Perak

Dr Chuah Siew Kee, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Sungai Buloh Consultant Physician, Department of Medicine, Jalan Hospital, 47000 Sungai Buloh, Selangor

Dr Yau Weng Keong, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Kuala Lumpur Consultant Physian and Geriatrician, Jalan Pahang, 50586 Kuala Lumpur

Locations

Hospital Raja Permaisuri Bainun

Jalan Hospital, 30990,, Ipoh, Perak, Malaysia

Hospital Kuala Lumpur

Jalan Pahang, 50586, Kuala Lumpur, Malaysia

Hospital Melaka

Jalan Mufti Haji Khalil, 75400, Melaka, Malaysia

Hospital Seberang jaya Jalan Tun Hussein Onn, 13700

Perai, Pulau Pinang, Malaysia

Hospital Sungai Buloh

Jalan Hospital, 47000, Sungai Buloh, Selangor, Malaysia

Hospital Sultanah Bahiyah

Km 6 Jalan Langgar, 5460 Alor Setar, Kedah, , Malaysia

Countries

Malaysia

Other Identifiers

SRM/CS/09-10/001

Identifier Type: -

Identifier Source: org_study_id