Acute Ischemic StrokePhase 2/3NCT06129175
UCMSCs as Treatment for Patients With Acute Ischemic Stroke (Stroke Neuroncell-EX)
A Phase 2/3 study testing Neuroncell-EX in people with Acute Ischemic Stroke, run by Cytopeutics Sdn. Bhd. at 1 site in Malaysia.
Trial summary
The primary objective of this study is to evaluate the functional recovery based on Barthel index (BI) and modified Rankin Scale (mRS) while the secondary objectives are to assess the survival and re-admission rate as well as to investigate the inflammatory response in a subclinical study within 1 year of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Neuroncell-EX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteMalaysia
- Study dates
- 19 Dec 2023to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be aged ≥ 18 years old.
- Patients with acute ischemic stroke symptom onset within 4 weeks.
- Patients diagnosed with "moderate to severe" based on NIHSS (6-24) at the time of recruitment.
- Patients who are not eligible for thrombolysis or thrombectomy.
- Written informed consent by the patient or next-of-kin.
Who cannot join
- Patients who are medically unfit such as those who are haemodynamically unstable or whose general condition is deteriorating.
- Patients with transient ischemic attack (TIA).
- Patients who have been diagnosed with malignancy (past or present) or primary haematological disorders.
- Patients who have renal impairment with serum creatinine more than 200 µmol/l or creatinine clearance less than 30 ml/min.
- Patients who have liver impairment with serum aspartate transaminase (AST) and alanine aminotransferase (ALT) two times greater than upper normal limit.
- Patients who are pregnant or are breastfeeding.
Show all 12Show fewer
- Patients diagnosed with brain hemorrhage or other pathological brain disorders such as vascular malformation (brain arteriovenous malformation), tumor, abscess, cardiogenic, inflammatory and infectious cerebral embolism or other common non- ischemic brain diseases, or diagnosed with severe brain atrophy, as determined by CT or MRI scans.
- Patients diagnosed/suspected diagnosis with acute coronary syndrome.
- Patients with congestive cardiac failure.
- Patients with history of confirmed or suspected pulmonary embolism or chronic obstructive pulmonary disease (COPD).
- Patients with mental, cognitive or psychological disorders that affects their understanding and adherence to research procedures and follow-ups.
- Patients that are undergoing experimental drug or instrument testing or have participated in other clinical drug trials in the past 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
Wan Nur Nafisah Wan Yahya, +603-91455798, nafisahyahya@gmail.com
Siti Zaleha Sahibulddin, zazz_lea21@yahoo.com
About this study
Official title: Cytopeutics® A Phase II-III Double-Blind Randomized Controlled Study to Assess the Efficacy of Umbilical Cord Mesenchymal Stem Cells (Neuroncell-EX) Transplantation in Patients With Acute Ischemic Stroke
The primary objective of this study is to evaluate the functional recovery based on Barthel index (BI) and modified Rankin Scale (mRS) while the secondary objectives are to assess the survival and re-admission rate as well as to investigate the inflammatory response in a subclinical study within 1 year of Neuroncell-EX infusion in participants with acute ischemic stroke.
Read the detailed description
Background: Ischemic stroke is a serious cerebrovascular disease with high morbidity and disability worldwide. Despite the great efforts that have been made, the prognosis of stroke patients remains unsatisfactory. Mesenchymal stem cells (MSCs) therapy is an emerging treatment studied in various medical conditions including autoimmune, inflammatory as well as central nervous system diseases. The mechanism of MSCs in the treatment of ischemic stroke involved with immune regulation, neuroprotection, angiogenesis, and neural circuit reconstruction. A large number of preclinical data have proved the feasibility of MSCs in the treatment of stroke where the administration of MSCs can alleviate neurological deficits. Similarly, a number of clinical trials have also proved the effectiveness and safety of MSCs in the treatment of stroke. Among these is a phase 2, single-center, assessor-blinded randomized controlled study by investigators using bone marrow-derived MSCs in patients with subacute middle cerebral artery infarct. The investigators demonstrated the safety, tolerability, and efficacy of intravenous infusion of MSCs with significant improvement in median infarct volume (Law et al., 2021).
Objective: To determine the efficacy of intravenous infusion of allogeneic Cytopeutics umbilical cord mesenchymal stem cells (Neuroncell-EX) in participants with acute ischemic stroke.
Study Design: This is a phase II-III double-blind randomized controlled study involving 80 participants, diagnosed with acute ischemic stroke admitted to HCTM-UKM. Investigational treatment arm (Group A-MSCs) consist of 40 participants will receive Neuroncell-EX whereas control treatment arm (Group B-Control) consist of 40 participants will receive placebo. Both groups will also receive standard medical care for acute stroke. Efficacy assessments will include Barthel index (BI) and modified Rankin Scale (mRS), Functional Magnetic Resonance Imaging (fMRI) and blood tests including biomarkers within 12 months follow-up.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Neuroncell-EX, Placebo
- Keywords
- Mesenchymal stem cells
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroncell-EXBiological
Intravenous infusion of Neuroncell-EX (2 million UCMSCs per kg body weight) on day 1 and day 14 plus standard medical care.
PlaceboOther
Intravenous infusion of Placebo (normal saline) on day 1 and day 14 plus standard medical care.
| Study group | Role | What they receive |
|---|---|---|
| Neuroncell-EX | Experimental | Umbilical cord-derived mesenchymal stem cells Receives: Biological: Neuroncell-EX |
| Control | Placebo comparator | Normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index (BI)
Functional recovery after stroke onset is measured by the Barthel Index (BI). BI score from 0-100, higher scores mean better outcome. The investigators measure and compare the BI score for ischemic stroke patients who received Neuroncell-EX and control treatments.
Measured: Baseline, 6 weeks, 3 months, 6 months and 12 months
Modified Rankin Scale
Functional recovery after stroke onset is measured by the modified Rankin Scale (mRS). mRS is a 7 point (0-6) ranking scale to assess neurological disability. A score of 0 indicates normal functions with no symptoms while higher scores indicates more severe neurological disability.The investigators measure and compare the mRS score for ischemic stroke patients who received Neuroncell-EX and control treatments.
Measured: Baseline, 6 weeks, 3 months, 6 months and 12 months
Secondary outcomes (3)
Number of participants with adverse events due to umbilical cord-derived mesenchymal stem cells infusion as assessed by clinical examination.
Presence or absence of any adverse events due to the umbilical cord-derived mesenchymal stem cells (UC-MSCs) infusion, sepsis, organ failure (clinically apparent or subclinical), hospitalization, cancers and death during the study period based on clinical examination.
Measured: Baseline, day 1, day 14, 6 weeks, 3 months, 6 months and 12 months
Survival and Re-admission rate
Survival and re-admission rate
Measured: Baseline, day 1, day 14, 6 weeks, 3 months, 6 months and 12 months
Blood inflammatory markers before and after umbilical cord derived mesenchymal stem cell infusion based on subclinical analysis.
Biomarkers concentration: Interleukin-6 (IL-6), interleukin-2 (IL-2), matrix metalloproteinase-9 (MMP-9), tumour necrosis factor alpha (TNFα), interleukin-1beta (IL-1β), vascular endothelial growth factor (VEGF), interleukin-10 (IL-10), Interleukin-1 receptor antagonist protein (IL-1Ra) and transforming growth factor beta 1 (TGF-β1).
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start19 Dec 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytopeutics Sdn. Bhd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University of Malaysia
- Responsible party
- Sponsor
- Investigators
- Wan Nur Nafisah Wan Yahya, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129175
- Sponsor's protocol ID
- POD0031/CP/R
- Status last verified
- Dec 2025
- First submitted
- 12 Oct 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytopeutics® A Phase II-III Double-Blind Randomized Controlled Study to Assess the Efficacy of Umbilical Cord Mesenchymal Stem Cells (Neuroncell-EX) Transplantation in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06129175
- Acronym / sponsor ID
- POD0031/CP/R
- Conditions
- Acute Ischemic Stroke
- Keywords
- Mesenchymal stem cells
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cytopeutics Sdn. Bhd.Industry (pharma, biotech, devices)
- Collaborators
- National University of Malaysia
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- 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.
The primary objective of this study is to evaluate the functional recovery based on Barthel index (BI) and modified Rankin Scale (mRS) while the secondary objectives are to assess the survival and re-admission rate as well as to investigate the inflammatory response in a subclinical study within 1 year of Neuroncell-EX infusion in participants with acute ischemic stroke.
Detailed description
Background: Ischemic stroke is a serious cerebrovascular disease with high morbidity and disability worldwide. Despite the great efforts that have been made, the prognosis of stroke patients remains unsatisfactory. Mesenchymal stem cells (MSCs) therapy is an emerging treatment studied in various medical conditions including autoimmune, inflammatory as well as central nervous system diseases. The mechanism of MSCs in the treatment of ischemic stroke involved with immune regulation, neuroprotection, angiogenesis, and neural circuit reconstruction. A large number of preclinical data have proved the feasibility of MSCs in the treatment of stroke where the administration of MSCs can alleviate neurological deficits. Similarly, a number of clinical trials have also proved the effectiveness and safety of MSCs in the treatment of stroke. Among these is a phase 2, single-center, assessor-blinded randomized controlled study by investigators using bone marrow-derived MSCs in patients with subacute middle cerebral artery infarct. The investigators demonstrated the safety, tolerability, and efficacy of intravenous infusion of MSCs with significant improvement in median infarct volume (Law et al., 2021).
Objective: To determine the efficacy of intravenous infusion of allogeneic Cytopeutics umbilical cord mesenchymal stem cells (Neuroncell-EX) in participants with acute ischemic stroke.
Study Design: This is a phase II-III double-blind randomized controlled study involving 80 participants, diagnosed with acute ischemic stroke admitted to HCTM-UKM. Investigational treatment arm (Group A-MSCs) consist of 40 participants will receive Neuroncell-EX whereas control treatment arm (Group B-Control) consist of 40 participants will receive placebo. Both groups will also receive standard medical care for acute stroke. Efficacy assessments will include Barthel index (BI) and modified Rankin Scale (mRS), Functional Magnetic Resonance Imaging (fMRI) and blood tests including biomarkers within 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuroncell-EX | Experimental | Biological: Neuroncell-EXUmbilical cord-derived mesenchymal stem cells |
| Control | Placebo comparator | Other: PlaceboNormal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be aged ≥ 18 years old.
- Patients with acute ischemic stroke symptom onset within 4 weeks.
- Patients diagnosed with "moderate to severe" based on NIHSS (6-24) at the time of recruitment.
- Patients who are not eligible for thrombolysis or thrombectomy.
- Written informed consent by the patient or next-of-kin.
Key exclusion criteria (12 listed)
- Patients who are medically unfit such as those who are haemodynamically unstable or whose general condition is deteriorating.
- Patients with transient ischemic attack (TIA).
- Patients who have been diagnosed with malignancy (past or present) or primary haematological disorders.
- Patients who have renal impairment with serum creatinine more than 200 µmol/l or creatinine clearance less than 30 ml/min.
- Patients who have liver impairment with serum aspartate transaminase (AST) and alanine aminotransferase (ALT) two times greater than upper normal limit.
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 |
|---|---|---|
| Neuroncell-EXIntravenous infusion of Neuroncell-EX (2 million UCMSCs per kg body weight) on day 1 and day 14 plus standard medical care. | Biological | Neuroncell-EX |
| PlaceboIntravenous infusion of Placebo (normal saline) on day 1 and day 14 plus standard medical care. | Other | Control |
Primary outcome
Barthel Index (BI)
Time frame: Baseline, 6 weeks, 3 months, 6 months and 12 months
Functional recovery after stroke onset is measured by the Barthel Index (BI). BI score from 0-100, higher scores mean better outcome. The investigators measure and compare the BI score for ischemic stroke patients who received Neuroncell-EX and control treatments.
Modified Rankin Scale
Time frame: Baseline, 6 weeks, 3 months, 6 months and 12 months
Functional recovery after stroke onset is measured by the modified Rankin Scale (mRS). mRS is a 7 point (0-6) ranking scale to assess neurological disability. A score of 0 indicates normal functions with no symptoms while higher scores indicates more severe neurological disability.The investigators measure and compare the mRS score for ischemic stroke patients who received Neuroncell-EX and control treatments.
3 secondary outcomes
Number of participants with adverse events due to umbilical cord-derived mesenchymal stem cells infusion as assessed by clinical examination.
Time frame: Baseline, day 1, day 14, 6 weeks, 3 months, 6 months and 12 months
Survival and Re-admission rate
Time frame: Baseline, day 1, day 14, 6 weeks, 3 months, 6 months and 12 months
Blood inflammatory markers before and after umbilical cord derived mesenchymal stem cell infusion based on subclinical analysis.
Time frame: Baseline, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
Wan Nur Nafisah Wan Yahya principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Neuroncell-EX in people with Acute Ischemic Stroke, run by Cytopeutics Sdn. Bhd. at 1 site 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sze Piaw Chin (+603-8688 1098, operation@cytopeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (BI) (time frame: Baseline, 6 weeks, 3 months, 6 months and 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 2 Jan 2026.