Phase 2 Stroke Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 80 years of any gender
• People who weigh between 45 and 90 kilograms
• People who have been diagnosed with an acute ischemic stroke (a stroke caused by a blocked blood vessel) that started between 6 and 72 hours before enrolling, who either received clot-dissolving treatment or are not planned to receive it, and are not planned for a clot-removal procedure
• People whose stroke severity falls within a moderate range, as measured by a standard stroke assessment tool (NIHSS score between 6 and 20), and who are not deeply unconscious
• People, or their legally authorised representative, who are able to understand and sign a written consent form

Who may not be able to join:

• People who had significant physical disability before the stroke, as measured by a standard disability scale (pre-stroke mRS score of 2 or higher)
• People who have a history of bleeding in or around the brain, or who show signs of new bleeding within the stroke-affected area alongside worsening symptoms, or who have other brain conditions such as vascular malformations, multiple sclerosis, severe brain injury, brain infection, or other conditions that can cause stroke-like symptoms
• People with poorly controlled health conditions including very high blood pressure (above 180/120 mmHg), severe or unstable diabetes, severely reduced kidney function, severe liver failure, severe heart failure, or serious chronic breathing problems
• People with a history of seizures, unless they had seizures linked to another condition and are not currently taking medication for them
• People who have had a brain tumour or most types of cancer in the past 5 years (some fully treated, early-stage cancers may be exceptions — confirm with trial site)
• People with a history of active or uncontrolled autoimmune disease, certain blood clotting disorders (such as Protein C or Protein S deficiency), sickle cell anaemia, deep vein thrombosis, pulmonary embolism, or abnormal blood vessels in the brain (such as moyamoya disease)
• People who have another condition or physical limitation (such as severe arthritis, amputation, or blindness) that would make it difficult to accurately measure their recovery using standard assessment tools
• People who have had major surgery (such as heart, chest, abdominal, or brain surgery) within the past 30 days
• People currently experiencing severe heart failure, a serious infection requiring systemic antibiotic or antifungal treatment within the past 14 days, immune system disorders, bleeding disorders, bone marrow transplantation, or uncontrolled depression or dementia that could affect study assessments
• People with an active uncontrolled infection, or who have received systemic infection treatment within 7 days before the study drug is given and where the infection may become uncontrolled
• People whose blood test results show abnormally low blood cell counts, poor liver or kidney function, or abnormal blood clotting results, beyond specified thresholds (confirm with trial site for exact values)
• People with significant, uncorrected imbalances in blood salts (such as potassium or sodium levels) that could affect study assessments
• People who are unable to have a CT or MRI brain scan for any reason, including having a pacemaker, metal implants, or severe claustrophobia
• People with a history of drug or alcohol misuse within the past year
• People with a known allergy to bovine (cow) or porcine (pig) products, human albumin products, or the antibiotic gentamicin
• People who have taken part in another clinical trial of an experimental drug, device, stem cell therapy, or immune cell therapy within the past 3 months
• People who have had a blood transfusion or received a live or weakened-virus vaccine within the past 3 months
• Women who are pregnant, breastfeeding, planning to become pregnant during the study, unwilling to use effective contraception, who have a positive pregnancy test, or who have been taking oral contraceptives continuously for more than 30 days
• People who the trial doctor considers unsuitable for any other reason, or who are unlikely to be able to complete all study requirements

Important: Always verify eligibility with the trial site directly before applying.