GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage

CellMed

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Intracerebral Hemorrhage (ICH)

Treatments: Drug: GLP-1 CellBeads

Study type: Interventional

Funder types: Industry

Identifiers

NCT01298830

CM GLP-1/01

2007-004516-31 (EudraCT Number)

Details and patient eligibility

About

The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage in conjunction with ICH by cranial computed tomography (CCT) or Magnetic Resonance Tomography (MRT)
• Patients who need by judgement of a clinical neurologist or neurosurgeon surgical removal of the blood clot due to its space-occupying effects
• Age greater or equal 18 years for men
• Age greater or equal 18 years for women if confirmed infertility (e.g. hysterectomy or surgical sterilisation at least 3 months before study start)
• For all other women age greater or equal 50 years with last menstrual bleeding at least one year before study start
• Minimum hematoma diameter of 2 cm as measured in baseline CCT or MRT
• Signed, written informed consent of patient or consent/assertion from the patient's legally acceptable representative/affiliated if the patient is unable to provide informed consent

Exclusion criteria

• Participation in any other clinical trial within the past 3 months or ongoing
• Occurrence of inconsistency with initial diagnosis at baseline during surgery of the patient leading to unfulfilled inclusion criterion Hemorrhage secondary to tumour or trauma
• Patients with a cerebellar hemorrhage or extension of a supratentorial hemorrhage into the brainstem
• Patients with severe pre-existing physical or mental disability or severe comorbidity that interferes with the assessment of outcome
• Allergy to contrast media (MRT)
• Acute infection
• Muscular, neurological, or vascular insufficiency of the respective tissue
• Polypropylene incompatibility
• Acute immunosuppressive medication
• Patient after organ transplantation
• Patient with immune depression
• Patients with a high probability of spontaneous recovery or showing rapidly improving signs
• Patients with extensive intracranial hemorrhages or with deep hemispheric localisation of the clots
• Patients whose diagnosis of ICH is uncertain

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

GLP-1 CellBeads

Experimental group

Treatment:

Drug: GLP-1 CellBeads