StrokePhase 1/2NCT01091701
Ex Vivo Cultured Adult Allogenic MSCs in Ischemic Cerebral Stroke
A Phase 1/2 study testing Ex vivo cultured adult allogenic MSCs and Plasmalyte-A in people with Stroke, run by Stempeutics Research Pvt Ltd at 6 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Ex vivo cultured adult allogenic MSCs and Plasmalyte-A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 6 sitesMalaysia
- Study dates
- Dec 2011to May 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Malaysia6 sites
Hospital Raja Permaisuri Bainun
Jalan Hospital, 30990,, Ipoh, Perak
Hospital Sungai Buloh
Jalan Hospital, 47000, Sungai Buloh, Selangor
Hospital Melaka
Jalan Mufti Haji Khalil, 75400, Melaka
Hospital Kuala Lumpur
Jalan Pahang, 50586, Kuala Lumpur
Hospital Sultanah Bahiyah
Km 6 Jalan Langgar, 5460 Alor Setar, Kedah
Hospital Seberang jaya Jalan Tun Hussein Onn, 13700
Perai, Pulau Pinang
About this study
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
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
- Being tested
- Ex vivo cultured adult allogenic MSCs, Plasmalyte-A
- Keywords
- Ischemic Cerebral Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ex vivo cultured adult allogenic MSCsBiological
Single IV dose of allogenic MSCs
Plasmalyte-AOther
Single IV dose of Plasmalyte-A
| Study group | Role | What they receive |
|---|---|---|
| Ex vivo cultured adult allogenic MSCs | Experimental | Not described Receives: Biological: Ex vivo cultured adult allogenic MSCs |
| Plasmalyte-A | Placebo comparator | Not described Receives: Other: Plasmalyte-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
The type of AE(s), number of AE(s) and proportion of patients with AE(s).
Measured: 12 Months
Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS).
Measured: 12 Months
Secondary outcomes (3)
Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living.
Measured: 12 Months
Improvement of Global outcome as assessed by the Modified Rankin Scale
Measured: 12 Months
MRI Parameters - Change in infarct size T2 - weighted images and blood flow in infarct area as evaluated by Diffusion Weighted Index
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startDec 2011
- Primary completionMay 2013 (estimated)
- Study completionMay 2013 (estimated)
Why it stopped: Business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stempeutics Research Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stempeutics Research Malaysia SDN BHD
- Investigators
- Dr Abdul Syukur Abdullah, MD, Principal investigator, Hospital Sultanah Bahiyah Consultant Physician, Medical Department, Km 6 Jalan Langgar, 5460 Alor Setar, KedahDr Irene Looi, MD, Principal investigator, Hospital Seberang jaya Jalan Tun Hussein Onn 13700 Prai, Pulau PinangDr Uduman Ali Mohamed Yousuf, MD, Principal investigator, Hospital Melaka Consultant Neurologist, Neurology Clinic, Medical Department, Jalan Mufti Haji Khalil, 75400 MelakaDr Dato K Chandran, MD, Principal investigator, Hospital Raja Permaisuri Bainun Consultant Physician, Jalan Hospital, 30990,Ipoh, PerakDr Chuah Siew Kee, MD, Principal investigator, Hospital Sungai Buloh Consultant Physician, Department of Medicine, Jalan Hospital, 47000 Sungai Buloh, SelangorDr Yau Weng Keong, MD, Principal investigator, Hospital Kuala Lumpur Consultant Physian and Geriatrician, Jalan Pahang, 50586 Kuala Lumpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091701
- Sponsor's protocol ID
- SRM/CS/09-10/001
- Status last verified
- Jun 2011
- First submitted
- 22 Mar 2010
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01091701
- Acronym / sponsor ID
- SRM/CS/09-10/001
- Conditions
- Stroke
- Keywords
- Ischemic Cerebral Stroke
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stempeutics Research Pvt LtdIndustry (pharma, biotech, devices)
- Collaborators
- Stempeutics Research Malaysia SDN BHD
- Study start
- Dec 2011
- Primary completion
- May 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ex vivo cultured adult allogenic MSCs | Experimental | Biological: Ex vivo cultured adult allogenic MSCs |
| Plasmalyte-A | Placebo comparator | Other: Plasmalyte-A |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ex vivo cultured adult allogenic MSCsSingle IV dose of allogenic MSCs | Biological | Ex vivo cultured adult allogenic MSCs |
| Plasmalyte-ASingle IV dose of Plasmalyte-A | Other | Plasmalyte-A |
Primary outcome
The type of AE(s), number of AE(s) and proportion of patients with AE(s).
Time frame: 12 Months
Improvement of neurological recovery as assessed by NIH Stroke Scale (NIHSS).
Time frame: 12 Months
3 secondary outcomes
Improvement of the Functional recovery - assessed by Barthel's Index for activities of daily living.
Time frame: 12 Months
Improvement of Global outcome as assessed by the Modified Rankin Scale
Time frame: 12 Months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Abdul Syukur Abdullah, MD principal investigator
Hospital Sultanah Bahiyah Consultant Physician, Medical Department, Km 6 Jalan Langgar, 5460 Alor Setar, Kedah
Dr Irene Looi, MD principal investigator
Hospital Seberang jaya Jalan Tun Hussein Onn 13700 Prai, Pulau Pinang
Dr Uduman Ali Mohamed Yousuf, MD principal investigator
Hospital Melaka Consultant Neurologist, Neurology Clinic, Medical Department, Jalan Mufti Haji Khalil, 75400 Melaka
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ex vivo cultured adult allogenic MSCs and Plasmalyte-A in people with Stroke, run by Stempeutics Research Pvt Ltd at 6 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The type of AE(s), number of AE(s) and proportion of patients with AE(s). (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.