Intracerebral Hemorrhage (ICH)
Conditions
Brief summary
The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.
Interventions
DRUGGLP-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.
Sponsors
CellMed AG, a subsidiary of BTG plc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Neurological conditions | 6 months |
Countries
Germany
Outcome results
None listed