Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT03463551
Eligibility Criteria:
Inclusion Criteria:
* Aged ≥18 years.
* Males or females not of child-bearing potential defined as being post-menopausal based on cessation of regular menses for a minimum of 12 consecutive months with no alternative cause, permanently sterilised (e.g. hysterectomy, bilateral tubal occlusion, bilateral salpingectomy), or having medically confirmed ovarian failure.
* Ischaemic stroke \<72h after onset.
* Previous functional independence (estimated mRS \<3).
* Capacity to consent.
Exclusion Criteria:
* Women of child bearing potential.
* Contraindications to MRI scanning (eg cardiac pacemaker, ferromagnetic implants, known hypersensitivity to gadolinium containing contrast media).
* Known allergy to ABL-101 or any of its constituents, (including egg phospholipids).
* Clinical need for, or contraindication to, supplemental oxygen.
* Known impaired renal function (eGFR \<30ml/min) precluding radiological contrast.
* Known thrombocytopaenia (platelet count \<150x109) or history of platelet function disorder.
* Known intercurrent infection.
* Known severe COPD or cardiac failure (eg significantly limiting exercise capacity or requiring hospitalisation within the preceding 12 months).
* Known significant liver disease (eg liver failure or cirrhosis, chronic infectious or autoimmune hepatitis, or transaminases \>3 times upper limit of normal).
* Any current medical condition causing impaired immunity (eg HIV infection, hyposplenism) or use of systemic immunosuppressant medication except for inhaled, nasal intra-articular or topical corticosteroids) on an ongoing basis or within the preceding 30 days.
* Any medical condition potentially limiting survival within the study follow-up period.
* Participation in another CTIMP within preceding 90 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03463551
Study Brief:
Protocol Section:
NCT03463551