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

• Status: Terminated
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CellMed AG, a subsidiary of BTG plc.
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

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