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Could stem cells help stroke patients recover? new trial begins

NCT ID NCT06129175

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Hospital Canselor Tuanku Muhriz UKM

    RECRUITING

    Cheras, Kuala Lumpur, 56000, Malaysia

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