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Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

Primary Purpose

Stroke

Status
Withdrawn
Phase
Phase 1
Locations
Malaysia
Study Type
Interventional
Intervention
Ex vivo cultured adult allogenic MSCs
Plasmalyte-A
Sponsored by
Stempeutics Research Pvt Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Ischemic Cerebral Stroke

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Raja Permaisuri Bainun
  • Hospital Kuala Lumpur
  • Hospital Melaka
  • Hospital Seberang jaya Jalan Tun Hussein Onn, 13700
  • Hospital Sungai Buloh
  • Hospital Sultanah Bahiyah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ex vivo cultured adult allogenic MSCs

Plasmalyte-A

Arm Description

Outcomes

Primary Outcome Measures

The type of AE(s), number of AE(s) and proportion of patients with AE(s).
Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS).

Secondary Outcome Measures

Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living.
Improvement of Global outcome as assessed by the Modified Rankin Scale
MRI Parameters - Change in infarct size T2 - weighted images and blood flow in infarct area as evaluated by Diffusion Weighted Index

Full Information

First Posted
March 22, 2010
Last Updated
May 11, 2016
Sponsor
Stempeutics Research Pvt Ltd
Collaborators
Stempeutics Research Malaysia SDN BHD
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1. Study Identification

Unique Protocol Identification Number
NCT01091701
Brief Title
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

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Business reasons
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Stempeutics Research Pvt Ltd
Collaborators
Stempeutics Research Malaysia SDN BHD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Ischemic Cerebral Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ex vivo cultured adult allogenic MSCs
Arm Type
Experimental
Arm Title
Plasmalyte-A
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Ex vivo cultured adult allogenic MSCs
Intervention Description
Single IV dose of allogenic MSCs
Intervention Type
Other
Intervention Name(s)
Plasmalyte-A
Intervention Description
Single IV dose of Plasmalyte-A
Primary Outcome Measure Information:
Title
The type of AE(s), number of AE(s) and proportion of patients with AE(s).
Time Frame
12 Months
Title
Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS).
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living.
Time Frame
12 Months
Title
Improvement of Global outcome as assessed by the Modified Rankin Scale
Time Frame
12 Months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Abdul Syukur Abdullah, MD
Organizational Affiliation
Hospital Sultanah Bahiyah Consultant Physician, Medical Department, Km 6 Jalan Langgar, 5460 Alor Setar, Kedah
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Irene Looi, MD
Organizational Affiliation
Hospital Seberang jaya Jalan Tun Hussein Onn 13700 Prai, Pulau Pinang
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Uduman Ali Mohamed Yousuf, MD
Organizational Affiliation
Hospital Melaka Consultant Neurologist, Neurology Clinic, Medical Department, Jalan Mufti Haji Khalil, 75400 Melaka
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Dato K Chandran, MD
Organizational Affiliation
Hospital Raja Permaisuri Bainun Consultant Physician, Jalan Hospital, 30990,Ipoh, Perak
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Chuah Siew Kee, MD
Organizational Affiliation
Hospital Sungai Buloh Consultant Physician, Department of Medicine, Jalan Hospital, 47000 Sungai Buloh, Selangor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Yau Weng Keong, MD
Organizational Affiliation
Hospital Kuala Lumpur Consultant Physian and Geriatrician, Jalan Pahang, 50586 Kuala Lumpur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Raja Permaisuri Bainun
City
Jalan Hospital, 30990,
State/Province
Ipoh, Perak
Country
Malaysia
Facility Name
Hospital Kuala Lumpur
City
Jalan Pahang, 50586
State/Province
Kuala Lumpur
Country
Malaysia
Facility Name
Hospital Melaka
City
Jalan Mufti Haji Khalil, 75400
State/Province
Melaka
Country
Malaysia
Facility Name
Hospital Seberang jaya Jalan Tun Hussein Onn, 13700
City
Prai
State/Province
Pulau Pinang
Country
Malaysia
Facility Name
Hospital Sungai Buloh
City
Jalan Hospital, 47000
State/Province
Sungai Buloh, Selangor
Country
Malaysia
Facility Name
Hospital Sultanah Bahiyah
City
Km 6 Jalan Langgar, 5460 Alor Setar, Kedah
Country
Malaysia

12. IPD Sharing Statement

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Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke

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