Using umbilical cord stem cells to treat acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy of intravenous infusion of allogeneic umbilical cord mesenchymal stem cells (Neuroncell-EX) in patients with acute ischemic stroke. It aims to assess functional recovery using the Barthel index and modified Rankin Scale, while also monitoring survival rates and inflammatory responses over one year. The study involves 80 participants and employs a double-blind, randomized controlled design to ensure robust results. The research builds on previous findings that suggest mesenchymal stem cells can alleviate neurological deficits in stroke patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Canselor Tuanku Muhriz UKM
  Cheras, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Principal investigator: Wan Nur Nafisah Wan Yahya — National University of Malaysia
• Study coordinator: Sze Piaw Chin
• Email: operation@cytopeutics.com
• Phone: +603-8688 1098

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Short-Term outside-in nerve stimulation for acute ischemic stroke

  This trial tests whether a 5-day external trigeminal nerve stimulation given after stroke can help more patients recover better than a sham treatment.

  Recruiting Xidian University · Xi'an · NCT07911605

• Sevoflurane vs. Propofol for anesthesia in stroke patients undergoing clot-removal

  This study tests whether sevoflurane or propofol used for anesthesia during endovascular treatment of an acute ischemic stroke affects the final brain damage and recovery.

  Recruiting Phase 3 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Barcelona · NCT07902791

• Safety of adding NRICM301 to standard care for adults with acute ischemic stroke

  This study tests whether adding NRICM301, a traditional Chinese medicine formula, to usual care is safe for adults with acute ischemic stroke.

  Recruiting En Chu Kong Hospital · New Taipei City · NCT07900503

• Intracranial Recanalization with LT3001 in Acute Ischemic Stroke

  This phase II study tests whether LT3001 given to adults with acute ischemic stroke can help reopen blocked brain arteries.

  Recruiting Phase 2 Lumosa Therapeutics Co., Ltd. · Taichung · NCT07890298

• Mobilisation After Endovascular Stroke Treatment

  This study checks whether moving around 12 hours after endovascular stroke treatment is as safe as moving around 24 hours for people with an acute ischemic stroke.

  Recruiting at 2 sites Karolinska Institutet · Tampere and 1 other locations · NCT07860333

• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

  In people with acute ischemic stroke due to distal or medium vessel blockages, this study tests whether adding endovascular treatment to the usual medical care helps improve outcomes compared with medical care alone.

  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.