Clinical trial NCT01091701: Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: Ischemic Cerebral Stroke
Lead sponsor: Stempeutics Research Pvt Ltd
Sponsor class: INDUSTRY
Collaborators: name: Stempeutics Research Malaysia SDN BHD
First posted: 2010-03-24
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The type of AE(s), number of AE(s) and proportion of patients with AE(s).
timeFrame: 12 Months
measure: Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS).
timeFrame: 12 Months
Secondary outcomes:
measure: Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living.
timeFrame: 12 Months
measure: Improvement of Global outcome as assessed by the Modified Rankin Scale
timeFrame: 12 Months
measure: MRI Parameters - Change in infarct size T2 - weighted images and blood flow in infarct area as evaluated by Diffusion Weighted Index
timeFrame: 12 Months
Other outcomes:
Locations:
city: Jalan Hospital, 30990,
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Ipoh, Perak
city: Jalan Pahang, 50586
country: Malaysia
facility: Hospital Kuala Lumpur
state: Kuala Lumpur
city: Jalan Mufti Haji Khalil, 75400
country: Malaysia
facility: Hospital Melaka
state: Melaka
city: Prai
country: Malaysia
facility: Hospital Seberang jaya Jalan Tun Hussein Onn, 13700
state: Pulau Pinang
city: Jalan Hospital, 47000
country: Malaysia
facility: Hospital Sungai Buloh
state: Sungai Buloh, Selangor
city: Km 6 Jalan Langgar, 5460 Alor Setar, Kedah
country: Malaysia
facility: Hospital Sultanah Bahiyah
Study officials:
affiliation: Hospital Sultanah Bahiyah Consultant Physician, Medical Department, Km 6 Jalan Langgar, 5460 Alor Setar, Kedah
name: Dr Abdul Syukur Abdullah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Seberang jaya Jalan Tun Hussein Onn 13700 Prai, Pulau Pinang
name: Dr Irene Looi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Melaka Consultant Neurologist, Neurology Clinic, Medical Department, Jalan Mufti Haji Khalil, 75400 Melaka
name: Dr Uduman Ali Mohamed Yousuf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Raja Permaisuri Bainun Consultant Physician, Jalan Hospital, 30990,Ipoh, Perak
name: Dr Dato K Chandran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Sungai Buloh Consultant Physician, Department of Medicine, Jalan Hospital, 47000 Sungai Buloh, Selangor
name: Dr Chuah Siew Kee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Kuala Lumpur Consultant Physian and Geriatrician, Jalan Pahang, 50586 Kuala Lumpur
name: Dr Yau Weng Keong, MD
role: PRINCIPAL_INVESTIGATOR
References: