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

March 22, 2010
June 16, 2011
December 2011
May 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01091701 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Stroke
  • Biological: Ex vivo cultured adult allogenic MSCs
    Single IV dose of allogenic MSCs
  • Other: Plasmalyte-A
    Single IV dose of Plasmalyte-A
  • Experimental: Ex vivo cultured adult allogenic MSCs
    Intervention: Biological: Ex vivo cultured adult allogenic MSCs
  • Placebo Comparator: Plasmalyte-A
    Intervention: Other: Plasmalyte-A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
78
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years to 80 Years
No
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
Malaysia
 
NCT01091701
SRM/CS/09-10/001
Yes
Dr Anjan K Das, Stempeutics Research Malaysia SDN BHD
Stempeutics Research Pvt Ltd
Stempeutics Research Malaysia SDN BHD
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
Stempeutics Research Pvt Ltd
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP