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

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

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

Conditions
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Intracerebral Hemorrhage (ICH)

Intervention / Treatment
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* Drug: GLP-1 CellBeads


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GLP-1 CellBeads<br> | Drug: GLP-1 CellBeads<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological conditions |  | 6 months |