Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Stempeutics Research Pvt Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Stempeutics Research Malaysia SDN BHD
Information provided by:
Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:
NCT01091701
First received: March 22, 2010
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Stroke
Biological: Ex vivo cultured adult allogenic MSCs
Other: Plasmalyte-A
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Stempeutics Research Pvt Ltd:

Primary Outcome Measures:
  • The type of AE(s), number of AE(s) and proportion of patients with AE(s). [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
  • Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS). [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Improvement of Global outcome as assessed by the Modified Rankin Scale [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • MRI Parameters - Change in infarct size T2 - weighted images and blood flow in infarct area as evaluated by Diffusion Weighted Index [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 78
Study Start Date: December 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ex vivo cultured adult allogenic MSCs Biological: Ex vivo cultured adult allogenic MSCs
Single IV dose of allogenic MSCs
Placebo Comparator: Plasmalyte-A Other: Plasmalyte-A
Single IV dose of Plasmalyte-A

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091701

Contacts
Contact: Anjan K Das, MD 6-03-8996-1023 anjan.das@stempeutics.com.my
Contact: Madhukumar MK 6-01-9210-9245 madhu@stempeutics.com.my

Locations
Malaysia
Hospital Kuala Lumpur Not yet recruiting
Jalan Pahang,, 50586 Kuala Lumpur, Malaysia
Contact: Dr Yau Weng Keong, MD    03- 2615 6116    dryauwk@gmail.com   
Contact: Dr Lee Fatt Soon, MD    03- 2615 6116      
Principal Investigator: Dr Yau Weng Keong, MD         
Hospital Sultanah Bahiyah Not yet recruiting
Km 6 Jalan Langgar,, 5460 Alor Setar, Kedah, Malaysia
Contact: Dr Abdul Syukur Abdullah, MD    04- 7407801    syuks77@gmail.com   
Contact: Dr Sharifah Baizura Bt Syed Alwi, MD    04- 7407801      
Principal Investigator: Dr Abdul Syukur Abdullah, MD         
Hospital Melaka Not yet recruiting
Jalan Mufti Haji Khalil,, 75400 Melaka, Malaysia
Contact: Dr Uduman Ali Mohamed Yousuf, MD    06- 2707171    uduman_ali@yahoo.com   
Contact: Dr. Koh Kee Leong, MD    06- 2707171      
Principal Investigator: Dr Uduman Ali Mohamed Yousuf, MD         
Hospital Raja Permaisuri Bainun Not yet recruiting
Jalan Hospital, 30990,, Ipoh, Perak, Malaysia
Contact: Dr Dato' K Chandran, MD    05- 2533 333    ackipoh@hotmail.com   
Contact: Dr Chong Li An, MD    05- 2533 333      
Principal Investigator: Dr Dato K Chandran, MD         
Hospital Seberang jaya Jalan Tun Hussein Onn Not yet recruiting
13700 Prai,, Pulau Pinang, Malaysia
Contact: Dr Irene Looi, MD    04- 3983333    irenelooi@yahoo.com   
Contact: Dr Ang Hock Aun, MD    04- 3983333      
Principal Investigator: Dr Irene Looi, MD         
Hospital Sungai Buloh Not yet recruiting
Jalan Hospital, 47000, Sungai Buloh, Selangor, Malaysia
Contact: Dr Chuah Siew Kee, MD    03- 61454333    cskllc@yahoo.com.sg   
Contact: Dr Rasidah Bt Senian, MD    03- 61454333      
Principal Investigator: Dr Chuah Siew Kee, MD         
Sponsors and Collaborators
Stempeutics Research Pvt Ltd
Stempeutics Research Malaysia SDN BHD
Investigators
Principal Investigator: Dr Abdul Syukur Abdullah, MD Hospital Sultanah Bahiyah Consultant Physician, Medical Department, Km 6 Jalan Langgar, 5460 Alor Setar, Kedah
Principal Investigator: Dr Irene Looi, MD Hospital Seberang jaya Jalan Tun Hussein Onn 13700 Prai, Pulau Pinang
Principal Investigator: Dr Uduman Ali Mohamed Yousuf, MD Hospital Melaka Consultant Neurologist, Neurology Clinic, Medical Department, Jalan Mufti Haji Khalil, 75400 Melaka
Principal Investigator: Dr Dato K Chandran, MD Hospital Raja Permaisuri Bainun Consultant Physician, Jalan Hospital, 30990,Ipoh, Perak
Principal Investigator: Dr Chuah Siew Kee, MD Hospital Sungai Buloh Consultant Physician, Department of Medicine, Jalan Hospital, 47000 Sungai Buloh, Selangor
Principal Investigator: Dr Yau Weng Keong, MD Hospital Kuala Lumpur Consultant Physian and Geriatrician, Jalan Pahang, 50586 Kuala Lumpur
  More Information

No publications provided

Responsible Party: Dr Anjan K Das, Stempeutics Research Malaysia SDN BHD
ClinicalTrials.gov Identifier: NCT01091701     History of Changes
Other Study ID Numbers: SRM/CS/09-10/001
Study First Received: March 22, 2010
Last Updated: June 16, 2011
Health Authority: Malaysia: Ministry of Health

Keywords provided by Stempeutics Research Pvt Ltd:
Ischemic Cerebral Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 29, 2014