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Could stem cells help stroke patients recover? new trial begins
NCT ID NCT06129175
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether umbilical cord stem cells (Neuroncell-EX) can improve recovery in people who recently had a moderate to severe stroke. Eighty participants will receive either the stem cells or a placebo, plus standard care. The goal is to see if the treatment helps with daily functioning and reduces disability over one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- umbilical cord mesenchymal stem cells (Neuroncell-EX)
- What this could lead to
- If it works, this could point toward a new treatment to improve functional recovery after a stroke, helping patients regain independence.
- What could go wrong
- This is an early-to-mid-stage trial with only 80 participants, so results may not be conclusive. Stem cell therapies also carry risks like infusion reactions or unknown long-term effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients must be aged ≥ 18 years old. 2. Patients with acute ischemic stroke symptom onset within 4 weeks. 3. Patients diagnosed with "moderate to severe" based on NIHSS (6-24) at the time of recruitment. 4. Patients who are not eligible for thrombolysis or thrombectomy. 5. Written informed consent by the patient or next-of-kin. Exclusion Criteria: 1. Patients who are medically unfit such as those who are haemodynamically unstable or whose general condition is deteriorating. 2. Patients with transient ischemic attack (TIA). 3. Patients who have been diagnosed with malignancy (past or present) or primary haematological disorders. 4. Patients who have renal impairment with serum creatinine more than 200 µmol/l or creatinine clearance less than 30 ml/min. 5. Patients who have liver impairment with serum aspartate transaminase (AST) and alanine aminotransferase (ALT) two times greater than upper normal limit. 6. Patients who are pregnant or are breastfeeding. 7. 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. 8. Patients diagnosed/suspected diagnosis with acute coronary syndrome. 9. Patients with congestive cardiac failure. 10. Patients with history of confirmed or suspected pulmonary embolism or chronic obstructive pulmonary disease (COPD). 11. Patients with mental, cognitive or psychological disorders that affects their understanding and adherence to research procedures and follow-ups. 12. Patients that are undergoing experimental drug or instrument testing or have participated in other clinical drug trials in the past 3 months.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Canselor Tuanku Muhriz UKM
RECRUITINGCheras, Kuala Lumpur, 56000, Malaysia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better