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

Phase 1

Terminated

• Conditions: Intracerebral Hemorrhage (ICH)
• Interventions: Drug: GLP-1 CellBeads

• Registration Number: NCT01298830
• Lead Sponsor: CellMed AG, a subsidiary of BTG plc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-18
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-25
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GLP-1 CellBeads	GLP-1 CellBeads	-

Primary Outcome Measures

Name	Time	Method
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage	6 months

Secondary Outcome Measures

Name	Time	Method
Neurological conditions	6 months

Trial Locations

Locations (6)

Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany

Neurochirurgische Klinik der Universität Erlangen-Nürnberg; 🇩🇪 Erlangen, Bavaria, Germany

Klinik für Neurochirurgie Medizinische Hochschule Hannover; 🇩🇪 Hannover, Lower Saxony, Germany

Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München; 🇩🇪 München, Bavaria, Germany

Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie; 🇩🇪 Hannover, Lower Saxony, Germany

International Neuroscience Institute; 🇩🇪 Hannover, Lower Saxony, Germany