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

NCT ID: NCT01298830

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-06-30

Brief Summary

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

Conditions

Intracerebral Hemorrhage (ICH)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

GLP-1 CellBeads

Group Type: EXPERIMENTAL

GLP-1 CellBeads

Intervention Type: DRUG

GLP-1 CellBeads are alginate microcapsules containing allogenic mesenchymal cells, transfected to secrete Glucagon like peptide-1. By implantation into brain tissue cavity after surgical evacuation of the hematoma, a volume of 500μl GLP-1 CellBeads which equals approximately 2330 GLP-1 CellBeads resulting in a total number of approximately 7.8 million cells is administered to the patient. The cells are removed by second surgery after a 14 days treatment period.

Interventions

GLP-1 CellBeads

GLP-1 CellBeads are alginate microcapsules containing allogenic mesenchymal cells, transfected to secrete Glucagon like peptide-1. By implantation into brain tissue cavity after surgical evacuation of the hematoma, a volume of 500μl GLP-1 CellBeads which equals approximately 2330 GLP-1 CellBeads resulting in a total number of approximately 7.8 million cells is administered to the patient. The cells are removed by second surgery after a 14 days treatment period.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CellMed AG, a subsidiary of BTG plc.

INDUSTRY

Sponsor Role: lead

Responsible Party

CellMed AG

Principal Investigators

Thomas Brinker, Prof. Dr.med.

Role: STUDY_CHAIR

International Neuroscience Institute Hanover

Locations

Neurochirurgische Klinik und Neurologische Klinik des Universitätsklinikums Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Neurochirurgische Klinik der Universität Erlangen-Nürnberg

Erlangen, Bavaria, Germany

Klinik für Neurochirurgie Klinikum Bogenhausen Akademisches Lehrkrankenhaus der Technischen Universität München

München, Bavaria, Germany

Klinikum Region Hannover Krankenhaus Nordstadt, Klinik für Neurologie

Hanover, Lower Saxony, Germany

International Neuroscience Institute

Hanover, Lower Saxony, Germany

Klinik für Neurochirurgie Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

Countries

Germany

Other Identifiers

2007-004516-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CM GLP-1/01

Identifier Type: -

Identifier Source: org_study_id