Trial | NCT01298830  Report issue

Official Title

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

  • Phase

    Phase 1/Phase 2

  • Lead Sponsor

    BTG

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    11
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.
Study Started
Oct 31
2008
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Last Update
Mar 26
2013
Estimate

Drug 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.

GLP-1 CellBeads Experimental

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
No Results Posted